A-01 Surface Plasmon Resonance Biosensor Analysis for Chloramphenicol Residue Determination in Crab and Shrimp W. C. Andersen1 , S. B. Turnipseed1 , C. M. Karbiwnyk1 , L. E. Carr2 , R. H. Lee2 , M. R. Madson2 , K. S. Kreuzer2 , 1Animal Drug Research Center, FDA, Denver, CO 80225, 2Denver District Laboratory, FDA, Denver, CO 80225
A-02 Compton Suppression Spectrometry for Analysis of Short-lived Neutron Activation Products in Foods D. L. Anderson, W. C. Cunningham, CFSAN, FDA, College Park
A-03 Characterizing perfluorochemical migration from food contact paper. T. H. Begley, W. Hsu, G. W. Diachenko, CFSAN, FDA, College Park, MD
A-04 Determination of Side-Reaction Products and an Intermediate in the Color Additives D&C Red Nos. 21 and 22 (Eosin Y) using High-Performance Liquid Chromatography H. W. Yang1 , H. T. Mai1 , A. Weisz2 , 1Office of Cosmetics and Colors, Color Certification Branch, FDA College Park, MD, 20740, 2Office of Cosmetics and Colors, Color Technology Branch, FDA College Park, MD 20740
A-05 Overcoming the Bottleneck of Sample Preparation using Tablet Processing Workstation I. Vertsman, Y. T. Cain, Wyeth Research, Wyeth
A-06 Ion Mobility Spectrometry - Successful Implementations and The Path Forward Y. T. Cain, M. Meyers, Wyeth Research, Wyeth
A-07 Rapid Packaging ID of Pharmaceutical Drug Product using Fiber Optic Probe Fluorescence Spectroscopy Y. T. Cain, M. Meyers, Wyeth Research, Wyeth
A-08 Fiber Optic Dissolution: The Future Y. T. Cain, J. L. Edgar, Wyeth Research, Wyeth
A-09 Analysis of erythromycin residues in salmon by LC-MS-MS S. Smith, C. S. Cheely, C. Gieseker, R. Reimschuessel, M. C. Carson, CVM, FDA, Laurel, MD
A-10 Determination of Total Bound and Free Residues of Nitrofurans in Milk of Lactating Cows Using Liquid Chromatography/Tandem Mass Spectrometry P. Chu, M. Lopez, CVM, FDA, Laurel, MD
A-11 Determination of Trace Amounts of Penicillin in Cephalosporins by Liquid Chromatography D. Dai, S. Wang, NRL, FDA, Jamaica, NY
A-12 Development of a SPME-GC-MS Method for the Determination of Coumarin in Vanilla Extract L. S. de Jager, G. A. Perfetti, G. W. Diachenko, CFSAN, FDA, College Park MD
A-13 A novel method of measuring mass loss from bioresorbable polymers containing optically-active compounds Q. Ge, R. V. Bahulekar, P. M. Amin, M. W. Diamond, F. M. Buevich, F. T. Do, R. A. Ebelle, S. K. Pulapura, A. C. Moses, W. C. McJames, TyRx Pharma, Inc.
A-14 Seafood Biotoxin Risk Management Success Story: 2005 New England Paralytic Shellfish Poisoning (Non)-Event S. M. Etheridge1 , J. R. Deeds1 , S. M. Conrad1 , S. Hall1 , P. DiStefano2 , M. Ellwanger2 , K. Chu3 , F. Pettengill4 , M. Hickey5 , D. Couture6 , 1OS, CFSAN, FDA, Laurel, MD, 2OS, CFSAN, FDA, College Park, MD, 3NOAA Fisheries Service, Gloucester, MA, 4Div. of Marine Fisheries, Gloucester, MA, 5MA Marine Fisheries, Pocasset, MA, 6Dept. of Marine Resources, W. Boothbay Harbor, ME
A-15 Size exclusion chromatography (SEC) with refractive index detection to assess the molecular weight (MW) of polysaccharides R. B. Shah, Y. Yang, M. A. Khan, P. J. Faustino, Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Science, FDA, Silver Spring, MD
A-16 Detection and Structural Characterization of Phosphodiesterase-5 Inhibitor Analogs in Suspect Counterfeit Products and Dietary Supplements S. R. Gratz, R. A. Flurer, M. R. Witkowski, C. L. Flurer, Forensic Chemistry Center, FDA, Cincinnati, OH
A-17 Studies of Variability in Dissolution Testing with USP Apparatus 2 Z. Gao, T. Moore, A. Smith, W. H. Doub, B. J. Westenberger, L. F. Buhse, FDA
A-18 Generic Drug Products Demonstrate Small Differences in Bioavailability Relative to the Brand Name Counterparts: A Review of ANDAs Approved 1996 - 2005 P. E. Nwakama, S. H. Haidar, Y. S. Yang, B. M. Davit, D. P. Conner, L. X. Yu, CDER, FDA, Rockville, MD
A-19 DIOXINS AND FURANS FOUND IN OLIVE OIL M. K. Halbert, J. C. Archer, ARL, FDA
A-20 Production and purification of marine biotoxins to support FDA research and regulatory programs S. Hall, S. M. Etheridge, J. R. Deeds, S. M. Conrad, WSL, OS, CFSAN, FDA, Laurel, MD
A-21 Automation for Isomer Specific Determination of Polychlorinated dibenzo-p-dioxins/furans, Polychlorinated biphenyls and Polybrominated diphenyl ethers in Foods and Feeds D. G. Hayward1 , T. S. Pisano2 , 1CFSAN, FDA, College Park, MD, 2JIFSAN, University of Maryland, College Park, MD
A-22 Method for determining fat in freeze-dried cow's milk during an automated extraction and purification procedure for halogenated organic pollutants T. S. Pisano1 , D. G. Hayward2 , 1JIFSAN, University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD
A-23 Method to Enforce Lead and Arsenic Specifications in Bone Black (D&C Back No. 3) Using X-Ray Fluorescence Spectrometry N.M. Hepp, Office of Cosmetics and Colors, CFSAN, FDA, College Park, MD
A-24 Determination of Methylmercury and Estimation of Total Mercury in Seafood by High Performance Liquid Chromatography (HPLC) and Inductively Coupled Plasma-Mass Spectrometry (ICP MS): Method Development and Ratio of Methyl/Total Mercury in Seafood S. C. Hight, J. Cheng, FDA
A-25 Determination of Retinol, Retinyl Palmitate and Retinoic Acid in Consumer Cosmetic Products J. C. Hubinger, D. C. Havery, Office of Cosmetics and Colors, CFSAN, FDA, College Park, MD
A-26 Comparison of Escherichia O157:H7 isolates using a multilocus variable-number tandem repeat analysis (MLVA) J. N. Jean-Giles, G. L. George, J. E. LeClerc, T. A. Cebula, Mod-1
A-PO-27 A Quick Method for Identification of Certifiable Color Additives By FTIR A. N. Joshi, J. Nickelsen, G. Gavini, FDA
A-28 NMR - An alternative method to Measure pKa. P. A. Jupp, D. Trew, C. H. Turner, Wyeth Research
A-29 Sensitive Liquid Chromatography/Tandem Mass Spectrometry Method for the Quantitation and Confirmation of Oxytocin in a Dilute IV Saline Solution C. M. Karbiwnyk1 , K. C. Faul2 , S. B. Turnipseed1 , W. C. Andersen1 , K. E. Miller3 , 1ORA, Animal Drugs Research Center, FDA, Denver, CO, 2ORA, FDA, Denver, CO, 3Univ. of Denver, Denver, CO
A-30 Establishment of ELISA for Quantification of Human Alpha-1-Proteinase Inhibitor E. Karnaukhova, B. Golding, Y. Ophir, Division of Hematology, CBER, FDA, Bethesda, MD
A-31 In vitro Complexes of Human Alpha-1-Proteinase Inhibitor with Retinoic Acid. A search for bi-functional drugs for treatment of human emphysema E. Karnaukhova, Division of Hematology, CBER, FDA, Bethesda, MD 20895
A-32 Interaction of Human Serum Albumin with Retinoids E. Karnaukhova, Division of Hematology, CBER, FDA, Bethesda, MD 20895
A-33 Separation, characterization and quantification of an unexpected degradant formed from tocopherol succinate polyethylene glycol using HPLC, LC-MS and NMR I. P. Leader, P. A. Jupp, P. Weatherhead, V. Huynh, D. Trew, C. H. Turner, T. Day, D. Wheatley, WYETH RESEARCH
A-34 Development of an LC/MS quantitative method for sulfadimethoxine residue and major metabolite in bovine tissues and fluids H. Li, P. J. Kijak, J. von Bredow, A. Chiesa, M. L. Smith, CVM, FDA, Laurel, MD
A-35 Simultaneous Quantitative Analysis of Histamine, Putrescine and Cadaverine of Scombroid Fish Samples and Fishery Products by Cationic Ion Chromatography B. S. Liao, T. T. Cain, PRL/SW, FDA, Irvine, CA
A-36 Determination of Nitrofuran Residues in Honey M. Lopez1 , M. Feldlaufer2 , P. Chu1 , 1CVM, FDA, 2ARS, USDA
A-37 Thermogravimetric Methods: Applications to Determination of Residual Moisture in Freeze-Dried Biological Products J. C. May1 , N. M. Etz1 , H. Wang1 , L. Rey2 , 1CBER, FDA, Rockville, MD, 2Conseiller Scientifique, Lausanne, Switzerland
A-38 Rapid Determination and Confirmation of Four Fluoroquinolone Residues in Fish Tissue S. E. McMullen, V. A. Vega, F. J. Schenck, SRL, Atlanta, GA
A-39 Novel Fluorometric Assay for Hydroxyl Radical Scavenging Capacity (HOSC) Estimation J. C. Moore1 , J. J. Yin2 , L. Yu1 , 1Dept. of Nutrition and Food Science, University of Maryland, College Park, MD, 2FDA, CFSAN, College Park, MD
A-41 Assessment of Tests Marketed for Detection Ruminant Proteins in Finished Feed H. F. Yancy, D. E. Farrell, J. D. Washington, C. M. Deaver, R. A. Frobish, CVM, FDA, Laurel, MD
A-42 Determination of MS-222 residues in farmed fish C. B. Nochetto, C. S. Cheely, C. Gieseker, R. Reimschuessel, M. C. Carson, CVM, FDA
A-43 Screening and Confirmatory Methods for the Detection of Monofluoroacetic Acid in Foods by Liquid Chromatography Mass Spectrometry. G. O. Noonan, T. H. Begley, G. W. Diachenko, CFSAN, FDA, College Park, MD
A-44 Determination of HKI-272 in Human Plasma by LC/MS/MS M. Hamed, L. Mello, M. Osman, Bioanalytical R&D, Wyeth Research, Collegeville, PA
A-45 Determination of PSI-697 in Human Plasma by LC/MS/MS L. Mello, S. Mathews, M. Khan, M. Osman, Bioanalytical R&D, Wyeth Research, Collegeville, PA
A-46 Stability-Indicating Method for Glycopyrrolate in Compounded Glycoprrolate Oral Suspension Formulae S. H. Atwell, P. A. White, S. Z. Wahab, United States Pharmacopeia
A-47 Method Development and Validation of an HPLC Assay Method for the Quantitation of Trimethoprim in Compounded Oral Preparations A. Ashley, R. Maheswaran, J. L. Belsky, S. Z. Wahab, United States Pharmacopeia
A-48 Method Development and Validation of an HPLC Assay Method for the Quantitation of Flecainide in Compounded Preparations of Flecainide Oral Suspensions R. Maheswaran, P. A. White, S. Z. Wahab, United States Pharmacopeia
A-49 Evaluation of Ginger Capsules by Dissolution Profile and Content of Marker Compounds E. Biba, L. R. Strauch, S. Z. Wahab, P. A. White, United States Pharmacopeia
A-50 Experimental Design for Dissolution Variance Study of USP Prednisone Tablets G. Deng1 , A. Ashley1 , W. Brown1 , J. Eaton1 , M. Liddell1 , L. Kikwai-Mutua1 , R. Manning1 , J. Munoz1 , B. Ning1 , P. Nithyanandan1 , H. Rowe1 , S. Tan1 , S. Z. Wahab1 , W. Hauck2 , 1United States Pharmacopeia, Rockville, MD, 2Thomas Jefferson University, Philadelphia, PA
A-51 Chemical and Physical Characteristics of USP Prednisone Tablets Lot P G. Deng, W. Brown, B. Chow, J. Eaton, M. Glasgow, M. Goede, L. Kikwai-Mutua, R. Manning, L. Wang, S. Z. Wahab, United States Pharmacopeia
A-52 USP Apparatus 4 Dissolution Profile of Prednisone Tablets Lot P J. Eaton, G. Deng, W. Brown, R. Manning, S. Z. Wahab, United States Pharmacopeia
A-53 GAS CHROMATOGRAPHIC ANALYSIS OF SUGARS AND SUGAR ALCOHOLS IN FOODS OF LOW CARBOHYDRATE CONTENT J. L. Perry, M. P. Yurawecz, CFSAN, FDA, College Park, MD
A-54 Direct Method for the Determination of Sudan I in FD&C Yellow No. 6 by Reversed-Phase High Performance Liquid Chromatography B. R. Petigara, A. L. Scher, CFSAN, FDA, College Park, MD
A-55 Direct Method for the Determination of Sudan I in D&C Orange No. 4 by Reversed-Phase High Performance Liquid Chromatography B. R. Petigara, A. L. Scher, CFSAN, FDA, College Park, MD
A-56 Immuno-Affinity Centrifugal Precipitation Chromatography: Pilot Studies L. Qi1 , Y. Ito2 , 1ONDQA, CDER, FDA, 2Center for Biochemistry and Biophysics, NHLBI, NIH
A-57 Use of HPLC analysis of ginsenoside content to develop a cost comparison among ten commercially available ginseng products. L. Caputo1 , N. Barnoy1 , J. Kim1 , J. Park1 , K. Senthil1 , P. Stahl1 , P. Delmonte2 , 1U.Md., 2CFSAN, FDA, College Park, Md.
A-58 Use of liquid chromatography-mass spectrometry and a hydrolytic technique for the detection and structure elucidation of a novel synthetic vardenafil designer drug added illegally to a "natural" herbal dietary supplement J. C. Reepmeyer, J. T. Woodruff, Division of Pharmaceutical Analysis, CDER, FDA, St. Louis, MO
A-59 DEVELOPMENT AND VALIDATION OF A MICROARRAY-BASED ASSAY THAT RAPIDLY DETECTS GENETIC VARIABILITY IN WEST NILE VIRUS GENOME. A. Grinev1 , S. Daniel1 , M. Laassri2 , K. Chumakov2 , V. E. Chizhikov2 , I. K. Hewlett1 , M. Rios1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2OVRR/CBER/FDA, Rockville, MD
A-60 Determination of usnic acid in toxic lichen by liquid chromatography with ultraviolet and tandem mass spectrometry detection J.A. Roach, CFSAN, FDA, College Park, MD
A-61 Determination of Avermectin Residues in Raw Milk, Pasteurized Whole Milk and Pasteurized Skim Milk using HPLC with Fluorescence Detection W. D. Rowe1 , M. R. Madson1 , J. N. Sofos1 , F. J. Schenck2 , V. A. Vega2 , L. H. Lagman3 , D. M. Altwein4 , 1FDA, Denver, CO, 2FDA, Atlanta, GA, 3FDA, Jefferson, AR, 4FDA, Bothell, WA
A-62 Development of Official Analytical Methods and Reference Materials for Dietary Supplements J. M. Betz1 , L. G. Saldanha1 , M. J. Smith2 , B. J. Cañas2 , Y. Tokiwa2 , L. C. Sander3 , K. E. Sharpless3 , S. A. Wise3 , 1Office of Dietary Supplements, NIH, Bethesda, MD, 2CFSAN, College Park, MD, 3National Institute of Standards and Technology , Gaithersburg, MD
A-63 Forensic Chemistry Center: Solutions to Current Forensic Challenges Using Multiple Analytical Approaches R.D. Satzger, FCC, ORA, FDA, Cincinnati, OH
A-64 Determination of Chlorothalonil Pesticide Residues in Produce Samples: Analytical Difficulties F. J. Schenck, S. E. McMullen, Southeast Regional Laboratory, FDA, Atlanta, GA
A-65 Isotopic Labeling Method for Quantitation of Peanut Allergens using Mass Spectrometry. K. J. Shefcheck, J. H. Callahan, S. M. Musser, CFSAN, FDA, College Park, MD
A-66 Intact Protein Biomarker Discovery for Determining Animal Host of Salmonella enterica serovar Newport T. L. Williams1 , R. Singh2 , H. C. Harbottle3 , D. Andrezjewski1 , D. N. Heller3 , R. D. Walker3 , S. M. Musser1 , 1CFSAN, FDA, College Park, MD 20740, 2CVM, FDA, Rockville, MD 20855, 3CVM, FDA, Rockville, MD 20708
A-67 Analysis of Aminoglycosides in Animal Feed by LC/MS M. L. Smith, D. N. Heller, CVM-OR, FDA, Laurel, MD
A-68 LC-MS Analysis of Star Anise, Black Cohosh and Grape Seed Extract. R. E. Smith, R. Luchtefeld, FDA
A-69 Analysis of dietary supplements containing Blue Cohosh (Caulophylum thalictroides) for major alkaloids and saponins by high performance liquid chromatography (HPLC) S. Satchithanandam1 , M. Ganzera2 , E. Grundel1 , K. D. White1 , J. I. Rader1 , 1CFSAN, FDA, College Park, MD, 2University of Innsbruck, Innrian 52, Austria
A-70 Use of LC/MS and NMR to identify selected diterpenoids in methanol extracts of authenticated Teucrium chamaedrys L. and T.canadense (Germander) P. R. Sundaresan1 , E. Grundel1 , K. D. White1 , E. Mazzola2 , J. I. Rader1 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA & Univ. MD, MD
A-71 Characterization of CMD-193, a Calicheamicin-Anti-Lewis Y Monoclonal Antibody Conjugate Using LC-MS and LC-MS/MS J. X. Tang, E. Vidunas, J. Moran, P. Desai, M. Ruppen, Wyeth Research, 401 North Middletown Road, Pearl River, NY 10965
A-72 LC-APPI-MS of Steroids and Small Organic Molecules Using PhotoSprayTM Ion Source J. X. Tang, R. Tsao, Wyeth Research, 401 North Middletown Road, Pearl River, NY 10965
A-73 Improved Method of Analysis for Histamine in Canned Fish without Derivatization S. Tefera, S. Ehling, S. J. Yoo, I. P. Ho, Food Products Association (FPA), Washington, DC
A-74 Determination of Aflatoxins in Ginseng Herbal Supplements E. Yanik1 , L. Lenz1 , C. M. Weaver2 , C. J. Oles3 , M. W. Trucksess2 , 1University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD, 3CFSAN, FDA,College Park, MD
A-75 Determination of Fumonisin B1 in Botanical Roots M. W. Trucksess1 , C. M. Weaver1 , C. J. Oles1 , J. I. Rader2 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA,College Park, MD
A-76 Development of a multi-class multi-residue LC-MS screening method for drugs residues in milk S. B. Turnipseed1 , C. M. Karbiwnyk1 , W. C. Andersen1 , S. B. Clark1 , K. E. Miller2 , 1ORA, FDA, Denver, CO, 2University of Denver, Denver, CO
A-77 Sulfite Determination in Dried Fruits: A Comparison of the Monier-Williams Procedure and Anion Exchange Chromatography J. R. Urban, D. S. Jackson, US FDA, Forensic Chemistry Center, Cincinnati, OH
A-78 IN VITRO GASTRIC AND INTESTINAL STABILITY OF VENLAFAXINE E. B. Asaju-Adjaye, P. J. Faustino, M. A. Tawakkul, D. A. Volpe, DPQR, CDER, FDA, Silver Spring, MD
A-79 A Novel Animal Model for Detecting Damage to Human Platelet Transfusion Products: In Vivo Recovery and Survival in Severe Combined Immunodeficient Mice. J. T. Piper, J. G. Vostal, CBER, FDA, Bethesda, MD
A-80 Analysis for Formaldehyde in influenza virus vaccines by an HPLC method H. Wang, N. M. Etz, J. C. May, CBER, FDA, Rockville, MD
A-81 Unravel the Mystery of NONMEM Estimation Methods by Visualization Y. Wang, CDER, FDA, Rockville, MD
A-82 Investigation of Flour Tortillas Implicated in Episodes of Illnesses Associated with School Lunches C. R. Warner1 , G. O. Noonan1 , N. Sugimoto2 , A. Beisaw3 , W. Hsu3 , G. A. Perfetti1 , T. H. Begley1 , G. W. Diachenko1 , 1FDA, College Park, MD, 2National Institutes of Health Sciences, Tokyo, 3JIFSAN, University of Maryland, College Park, MD
A-83 Antimicrobial Resistance and Genetic Relatedness among Salmonella from Retail Foods of Animal Origin: NARMS Retail Meat Surveillance S. Zhao1 , P. F. McDermott1 , S. Friedman1 , J. W. Abbott1 , S. L. Ayers1 , A. Glenn1 , E. Hall-Robinson1 , S. K. Hubert1 , H. C. Harbottle1 , R. D. Walker1 , T. M. Chiller2 , D. G. White1 , 1CVM, FDA, Rockville, MD, 2CDC, Atlanta, GA
A-84 Differentiation of Enterobacter sakazakii from closely related Enterobacter and Citrobacter species using fatty acid profiles P. Whittaker1 , C. E. Keys1 , E. W. Brown1 , B. D. Tall2 , S. G. Edelson-Mammel1 , F. S. Fry1 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA, Laurel, MD
A-85 Quality by Design in Analytical Chemistry L. J. Wrisley, L. Zhang, Wyeth Research
A-86 Gas chromatography/mass spectrometry determination of carbon monoxide in commercially treated tuna and mahi-mahi W. H. Wu, C. R. Anderson, PRLNW/SPRC, ORA, FDA, Bothell, WA
A-87 Effects of Conjugated Linoleic Acid (CLA) Isomers on Oxygen Diffusion-Concentration Products in Liposomes and Phospholipid Solutions J. J. Yin1 , M. P. Yurawecz2 , J. K. Kramer3 , A. R. Eynard4 , L. Yu5 , 1CFSAN, FDA, College Park, MD, 2Retired, 3Agri-Food Canada, 4Universidad Nacional de Córdoba, Argentina, 5University of Maryland
A-88 Accurate Identification of Trans Fatty Acid Methyl Ester Peaks Using GC-FID on a Polar Capillary Column S. J. Yoo, E. Kwok, I. P. Ho, Food Products Association (FPA), Washington, DC
A-PO-89 SIMULATED FIELD APPLICATION OF PEDXRF FOR THE DETECTION OF ACUTE LEVELS OF SOME TOXIC ELEMENTS IN TWO MODEL FOODS R. M. Jacobs1 , P. T. Palmer2 , 1ORA,FDA, Alameda, CA, 2SFSU, San Francisco, CA
A-PO-90 PEDXRF - A FASTER, SIMPLER, AND CHEAPER ALTERNATIVE TO ATOMIC SPECTROMETRY FOR SCREENING OF PPM TO PERCENT LEVELS OF TOXIC ELEMENTS IN FOODS AND MEDICINES P. T. Palmer1 , R. M. Jacobs2 , K. Yamamoto3 , S. Webber3 , K. Ferguson3 , 1SF District Lab & SF State University, San Francisco, CA, 2SF District Lab, Alameda, CA, 3SF State University, San Francisco, CA
A-91 Development of an LC-UV Method for the Determination of Coumarin in Vanilla Extract L.H. Ali, G.A. Perfetti, and G.W. Diachenko, CFSAN, FDA
B-01 ALTERATIONS IN BLOOD-BRAIN BARRIER FUNCTION BY MORPHINE AND METHAMPHETAMINE H. S. Sharma1 , S. F. Ali2 , 1University of Uppsala, Sweden, 2NCTR, FDA, Jefferson, AR
B-02 Increasing Confidence Level in DNA Microarray Chip Hybridization Data of 71 Genes with PCR Amplification of 10 genes in Salmonella Typhimurium S. F. Al-Khaldi1 , S. Courtney2 , M. E. Mossoba1 , T. S. Hammack1 , C. E. Keys1 , 1CFSAN,FDA, College Park, MD, 2JIFSAN,FDA, College Park, MD
B-03 Evaluation of Commercially Available ELISA-Based Kits for Protein Fining Agents in Wine J. R. Ammann1 , M. A. Mabud1 , E. A. Garber2 , 1Alcohol and Tobacco Tax and Trade Bureau, US Treasury Dept., Beltsville, MD 20705, 2CFSAN, FDA, College Park, MD 20740
B-04 Differential reactive oxygen and nitrogen production and clearance of Salmonella serovars by chicken and mouse macrophages U. S. Babu1 , D. W. Gaines1 , H. Lillehoj2 , R. B. Raybourne1 , 1FDA, Mod I, Laurel, MD, 2USDA, Beltsville, MD
B-05 An Improved Automated Enzyme Linked Immunosorbent Assay Based Method for Detection of Staphylococcal Enterotoxin by Antibody Modification R.W. Bennett, CFSAN, College Park, MD
B-06 Aminoglycoside Resistance Genes Found in Enterococcus spp. Recovered From Retail Meats S. M. Bodeis-Jones, D. G. White, T. NARMS Working Group, FDA, CVM, Office of Research, Laurel, MD
B-07 Intraperitoneal administration of lipopolysaccharide (LPS) produces a stable juvenile pig model of endotoxemia for toxicity testing of compounds released from medical device materials D. Wray-Cahen1 , R. P. Brown1 , A. I. Steen2 , H. Baskar3 , M. E. Stratmeyer1 , 1MOD2, CDRH, FDA, Laurel, MD, 2ODE, CDRH, FDA, Rockville, MD, 3University of Maryland
B-08 Intravenously administered ethylene glycol (EG) produces hemolysis and hemodynamic changes in the pig R. P. Brown1 , D. Wray-Cahen2 , A. D. Lucas1 , A. I. Steen3 , H. Baskar4 , M. E. Stratmeyer1 , 1CDRH, FDA, Silver Spring, MD, 2CDRH, FDA, Laurel, MD, 3CDRH, FDA, Rockville, MD, 4University of Maryland, College Park, MD
B-09 Cytotoxicity of extracts from ethylene oxide-sterilized cardiopulmonary bypass oxygenators R. P. Brown1 , A. D. Lucas1 , V. M. Hitchins1 , M. D. O'Hara1 , T. L. Murray2 , W. H. Cyr1 , M. E. Stratmeyer1 , S. F. Ali3 , M. Srivatasan4 , 1CDRH, FDA, Silver Spring, MD, 2CDRH, FDA, Laurel, MD, 3NCTR, FDA, Jefferson, AR, 4Arkansas State University, Little Rock, AR
B-10 Cell line sensitivity to a cleaning agent and disinfectant used to reprocess single-use medical devices H. Baskar1 , A. I. Steen2 , R. P. Brown3 , 1University of Maryland, College Park, MD, 2CDRH, FDA, Rockville, MD, 3CDRH, FDA, Silver Spring, MD
B-11 Qualitative Analysis of Streptococcus Group A Rapid Antigen Detection Test Kit G. S. Bushar1 , R. Shively2 , S. C. Wood1 , M. M. Lightfoote1 , 1CDRH, FDA, Silver Spring, MD, 2CDRH, FDA, Rockville, MD
B-12 The PE_PGRS33 protein of Mycobacterium tuberculosis induces an immune response that may benefit the pathogen. N. Cadieux, V. Dheenadhayalan, M. Parra, M. J. Brennan, CBER, FDA, Bethesda, MD
B-13 Bazedoxifene acetate in vitro metabolism A. Chandrasekaran, S. Ahmad, W. DeMaio, T. Hultin, R. Talaat, J. A. Scatina, Department of Biotransformation, Wyeth Research, Collegeville, PA
B-14 Multi-virulence-locus sequence typing identifies epidemic clones from numerous listeriosis outbreaks Y. X. Chen1 , W. Zhang2 , S. J. Knabel1 , 1The Pennsylvania State University, University Park, PA, 16801, 2Illinois Institute of Technology, Summit, Illinois, 60501
B-15 Precision Treatment of Sand Rats (Psammomys obesus) with Insecticides to Control Phlebotomine Sand Flies (Phlebotomus papatasi): Challenges in Parasite Control and Treatment V. M. Chenault1 , M. G. Hodges2 , C. P. Schnupp1 , P. W. Miles3 , V. B. Solberg3 , 1FDA, 2NIH, 3WRAIR
B-16 Reduced fitness of individual parts of vaccine poliovirus genomes may determine the pattern of their recombination in vivo E. Cherkasova1 , E. Korotkova2 , V. Agol3 , K. M. Chumakov1 , 1CBER, FDA, Rockville, MD, 2A. N. Belozersky Institute of Physical-Chemical Biology, Moscow State University, Moscow, Russia, 3M. P. Chumakov Institute of Poliomyelitis and Viral Encephalitides, Russian Academy of Medical Sciences, Moscow, Russia
B-17 Characterization of Campylobacter recovered from NARMS Retail Meats by Pulsed-Field Gel Electrophoresis P. Cullen, S. L. Friedman, J. W. Abbott, L. L. English, A. A. Stearns, P. F. McDermott, S. Zhao, D. G. White, R. D. Walker, FDA, Laurel, MD
B-18 Evaluation of inactivation methods for severe acute respiratory syndrome coronavirus (SARS-CoV) in non-cellular blood products M. R. Darnell, D. R. Taylor, CBER, Office of Blood Research and Review, FDA, Rockville, MD
B-19 Exploring the programmed cell death pathways of human parasites to identify novel drug targets N. Lee, S. Gannavaram, A. Selvapandiyan, A. Debrabant, CBER, FDA, Bethesda, MD
B-21 Effects and Interactions of pH and Water Activity (aw) on the Thermal Resistance of Listeria monocytogenes F4258: Examining the Impact of Acid Adaptation S. G. Edelson-Mammel1 , R. C. Whiting2 , S. W. Joseph3 , R. L. Buchanan4 , 1DDES,OPDF, FDA, College Park, MD, 2OPDF, FDA, College Park, MD, 3CBMG, UMD, College Park, MD, 4OSCI, FDA, College Park, MD
B-22 Inactivation of Escherichia coli O157:H7, Salmonella spp. and Listeria monocytogenes in Cranberry Juice Concentrates E. Enache, Y. Chen, Food Products Association, Washington, DC 20005
B-23 Characterization of a Rodent Pediatric Nephrotoxicity Model P. Espandiari1 , T. J. Miller1 , J. Zhang1 , A. D. Knapton1 , P. L. Goering2 , R. P. Brown2 , V. S. Vaidya3 , A. M. Johnson3 , J. V. Bonventre3 , B. A. Rosenzweig1 , K. L. Thompson1 , P. S. Pine1 , S. Schnackenberg4 , R. D. Beger4 , E. H. Herman1 , J. L. Weaver1 , J. P. Hanig1 , 1CDER, FDA, Silver Spring, MD, 2CDRH, FDA, Silver Spring, MD, 3Harvard Medical School, Boston, MA, 4NCTR, Jefferson, AR
B-24 Anthrax Lethal Toxin Has Direct and Potent Inhibitory Effects on B Cell Proliferation and Immunoglobulin Production H. Fang, L. Xu, T. Chen, J. Cyr, D. M. Frucht, DMA,OBP,CDER,FDA
B-25 Interferon-alpha effectively inhibits replication of HIV-1 in human macrophages, but not T-lymphocytes: Influence of cell type and co-receptor use K. H. Fields1 , F. Schwartzkopff1 , R. Hu2 , H. Schmeisser2 , J. Bekisz2 , C. R. Lankford1 , K. Zoon2 , K. A. Clouse1 , 1CDER, FDA, Bethesda, MD 20892, 2NIAID, NIH, Bethesda, MD 20892
B-26 Attachment, growth and differentiation of cryopreserved human hepatocytes in culture - development of a method for studying mechanisms of chemical-induced hepatotoxicity T. J. Flynn, C. Y. Kelly, CFSAN, FDA, Laurel, MD
B-27 Endonuclease G is an important cell death nuclease in trypanosotmatid parasites S. Gannavaram, A. Debrabant, Laboratory of Bacterial Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Bethesda, MD 20892
B-28 Impact of Seven Day Storage on Immunophenotypes and Activities of Cell Membrane Microparticles in Apheresis Platelets M. P. Gelderman-Fuhrmann1 , O. Simakova2 , L. B. Carter1 , J. Simak3 , 1FDA, Rockville, MD, 2USUHS, Bethesda, MD, 3DFA, Rockville, MD
B-29 Role of double stranded RNA (dsRNA) in apoptosis induction by hepatitis A virus M. Kulka, B. B. Goswami, T. A. Cebula, D. Ngo, M. Ayodeji, CFSAN, OARSA, FDA, Laurel, MD
B-30 Detection of Escherichia coli O157:H7 in Produce M. A. Grant, R. M. Trump, Pacific Regional Laboratory, Northwest, FDA, Bothell, WA
B-31 MECHANISM OF ESCAPE FROM HIV PEPTIDE FUSION N. Gupta1 , W. Wang2 , E. Desmezieres2 , R. Vassell1 , Y. He1 , P. Wingfield3 , C. D. Weiss2 , 1CBER,FDA,BETHESDA,MD, 2CBER,FDA,BETHESDA,,MD, 3NIH,BETHESDA,MD
B-32 Effectiveness of the Bacteriological Analytical Manual Salmonella Culture Method for the Recovery of Salmonella Typhi from Selected Foods T. S. Hammack, A. P. Jacobson, W. H. Andrews, CFSAN, FDA, College Park, MD
B-33 Comparison of Salmonella enterica serotype Newport isolates from 1958-2003 using Multi-Locus Sequence Typing and Antimicrobial Susceptibility Profiling H. C. Harbottle1 , D. G. White2 , S. Zhao1 , R. D. Walker1 , P. F. McDermott1 , 1FDA, CVM, OR, DAFM, Laurel, MD, 2FDA, CVM, OR, Laurel, MD
B-34 Real Time PCR Detection of 16S rRNA Genes Speeds MPN Enumeration of Foodborne Listeria monocytogenes E. C. De Martinis, R. E. Duvall, A. D. Hitchins, CFSAN, FDA, College Park, MD
B-35 Proteomic Analysis of Lymph Nodes in Female SKH-1 Hairless Mice Following Tattooing N. V. Gopee1 , R. D. Edmondson1 , S. Thyparambil1 , R. C. Jones1 , J. T. Taylor1 , W. G. Wamer2 , P. C. Howard1 , 1NCTR, Jefferson, AR, 2CFSAN, College Park, MD
B-36 Gene Expression Profiles in Tattooed Skin of SKH-1 Hairless Mice N. V. Gopee1 , V. G. Desai1 , B. J. Miller1 , J. C. Fuscoe1 , W. Tong1 , H. Fang1 , W. G. Wamer2 , P. C. Howard1 , 1NCTR, Jefferson, AR, 2CFSAN, College Park, MD
B-37 Quantification of Nanoscale Quantum Dot Fluorescence in Tissues P. C. Howard1 , N. V. Gopee1 , A. R. Warbritton2 , N. J. Walker3 , W. W. Yu4 , V. L. Colvin4 , P. Webb1 , R. L. Bronaugh5 , M. E. Kraeling5 , D. W. Roberts1 , 1NCTR, Jefferson, AR, 2Toxicol. Pathology Assoc., Jefferson, AR, 3NIEHS, Research Triangle Park, NC, 4Rice University, Houston, TX, 5CFSAN, Laurel, MD
B-38 Penetration of Nanoscale Quantum Dots in Dermabraded Mouse Skin N. V. Gopee1 , D. W. Roberts1 , P. Webb1 , C. Cozart1 , P. Siitonen1 , A. R. Warbritton2 , N. J. Walker3 , W. W. Yu4 , V. L. Colvin4 , P. C. Howard1 , 1NCTR, Jefferson, AR, 2Toxicol. Pathol. Assoc., Jefferson, AR, 3NIEHS, Research Triangle Park, NC, 4Rice University, Houston, TX
B-39 Comparison of five methods of sample preparation for the isolation of Salmonella from alfalfa seeds A. P. Jacobson, T. S. Hammack, W. H. Andrews, FDA, College Park, MD
B-40 Pulsed Field Gel Electrophoresis of Enterobacter sakazakii Strains Reveals Extensive Genotypic Diversity C. E. Keys, P. Whittaker, F. S. Fry, E. W. Brown, CFSAN, FDA, College Park, MD
B-41 Single Enzyme Pulsed-Field Gel Electrophoresis is a Poor Evolutionary Indicator in Salmonella E. W. Brown, C. E. Keys, CFSAN, FDA, College Park, MD
B-42 Antimicrobial Resistance Patterns of Salmonella Isolated from FDA Regulated Products During 2005 C. R. Kiessling1 , M. B. Buen1 , W. M. Kiessling1 , E. W. Laster1 , M. H. Loftis1 , J. N. Sofos2 , 1FDA, 2Colorado State University
B-43 Involvement of Interleukin-13 Receptor in Development of Glioblastoma Multiforme M. Kioi1 , J. Han1 , E. Michishita2 , T. Shimamura1 , R. K. Puri1 , 1CBER, FDA, Bethesda, MD, 2NCI, NIH, Bethesda, MD
B-44 Preclinical Data to Support Human Studies of Immune Globulin Products H.S. Ko, CBER, FDA, Rockville, MD
B-45 Sunburn Cell Formation in Human Skin Induced by UV-exposure. Is this Process Dose-Rate Dependent? A. Kornhauser1 , R. R. Wei1 , J. C. Hubinger2 , C. N. Barton2 , K. Kaidbey3 , S. A. Miller4 , S. G. Coelho5 , J. Z. Beer5 , B. Z. Zmudzka5 , V. J. Hearing6 , Y. Yamaguchi6 , 1FDA, College Park, MD, 2FDA, College Park, MD, 3Ivy Laboratories, PA, 4FDA, Rockville, MD, 5FDA, Rockville, MD, 6NCI, Bethesda, MD
B-46 In Vitro Percutaneous Absorption of Salicylic Acid in Hairless Mouse and Human Skin M. E. Kraeling, R. L. Bronaugh, Office of Cosmetics and Colors, CFSAN, FDA, Laurel, MD
B-47 Evaluation of Genetic Stability of Chimera WN/DEN4-3'Delta30 the New Candidate of West Nile Vaccine M. Laassri1 , A. Pletnev2 , K. M. Chumakov1 , 1CBER, FDA, Rockville, MD, 2NIAID, NIH, Bethesda, MD
B-48 Residual Total Protein and Total Organic Carbon Levels on Reprocessed Gastrointestinal (GI) Biopsy Forceps S. K. Lappalainen, S. V. Gomatam, V. M. Hitchins, FDA, CDRH, Rockville, MD 20850
B-49 Residual Total Protein and Total Organic Carbon Levels on Reprocessed Bidirectional Steerable Cardiac Ablation Catheters S. K. Lappalainen, S. V. Gomatam, V. M. Hitchins, FDA, CDRH, Rockville, MD 20850
B-50 Combined synthesis of multi-valent conjugate vaccines C. H. Lee, W. C. Kuo, CBER, FDA, Rockville, MD
B-51 In Vitro Protection of Human Endothelial Cells from Adenovirus Vector Toxicity by Activated Protein C. J. N. Lozier, F. d'Agnillo, CBER, FDA, Rockville, MD
B-52 Mild hyperthermic incubation can potentiate the cytotoxicity of exogenous compounds and medical device extracts A. D. Lucas, D. Wray-Cahen, R. P. Brown, S. K. Lappalainen, CDRH, FDA Silver Spring MD
B-53 A Preliminary Limited Study on Detection of Shigella sonnei from Cantaloupe Rinse by Culturing with or without Pre-enrichment, Cell Capture, and Aerobic or Anaerobic Enrichment S. M. Madson1 , E. W. Laster1 , M. Z. Thomas1 , K. A. Watts1 , J. N. Sofos2 , 1FDA Denver District Laboratory, Denver, CO 80225, 2Colorado State University, Fort Collins, CO 80523
B-54 Negligible Risk of Integration of Plasmid-based Vaccines Delivered with Cationic Lipid- and Poloxamer-based Formulations or with Electroporation R. K. Mahajan, A. Vilalta, J. Hartikka, T. Martin, D. Jones, V. Bozoukova, D. Rusalov, P. Lalor, K. Hall, M. Sawdey, A. Rolland, D. Kaslow, Vical, Inc.
B-55 Some Suggestions for Non-clinical Testing of Topical Combination Products Developed From Marketed Drugs for the Treatment of Dermatomycoses. K.D. Mainigi, CDER, Silver Spring, MD
B-56 Assessing the Potential of Cell Substrates Used for Vaccine Production to Propagate the Agents of Transmissible Spongiform Encephalopathies (TSEs) O. A. Maximova1 , I. Bacik1 , K. L. Pomeroy1 , J. Cervenak1 , I. Vasilyeva2 , O. Yakovleva2 , L. Cervenakova2 , P. Piccardo1 , D. M. Asher1 , 1CBER, FDA, Rockville , MD, 2The Jerome Holland Laboratory, American Red Cross, Rockville, MD
B-57 Comparison of antimicrobial susceptibility profiles among Salmonella spp. recovered from retail poultry, NARMS 2002-2004. S. K. Hubert, S. L. Ayers, A. Glenn, E. Hall-Robinson, P. F. McDermott, L. A. Walker, T. Proeschodt, S. Zhao, S. L. Friedman, J. W. Abbott, R. D. Walker, D. G. White, CVM Office of Research, Laurel, MD
B-58 Ampicillin and Gentamicin Resistance in E. coli from 1950 - 2002 P. F. McDermott1 , S. K. Hubert1 , J. Tang2 , L. Quesada2 , R. D. Walker1 , 1CVM Office of Research, Laurel, MD, 2American Type Culture Collection, Manassas, VA
B-59 Utilization of sucrose and D-serine in foodborne Escherichia coli pathogens A. Mukherjee, K. L. McCutchan, D. Roberson, J. E. LeClerc, T. A. Cebula, CFSAN, FDA, Laurel, MD
B-60 Threat Assessment of Potentially Emerging Salmonella Serovars Associated with Roma Tomato Outbreak and Egg Houses in the United States E. Job1 , G. Wagley2 , S. F. Al-Khaldi2 , S. L. Foley3 , D. E. Farmer2 , M. O. Walderhaug2 , K. Kerdahi2 , C. E. Cerniglia2 , R. Nayak2 , 1Brigham Young Univ., 2FDA, 3Marshfield Clinic Research Foundation
B-61 Genotyping of measles virus in clinical specimens based on oligonucleotide microarray hybridization patterns A. A. Neverov1 , M. A. Riddell2 , W. J. Moss3 , D. V. Volokhov1 , P. A. Rota4 , L. E. Lowe4 , D. Chibo2 , S. B. Smit5 , D. E. Griffin3 , K. M. Chumakov1 , V. E. Chizhikov1 , 1CBER, FDA, Rockville, MD, 20852, 2Victorian Infectious Diseases Reference Laboratory, Melbourne, Victoria, Australia, 3051, 3Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, 4National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, 5National Institute for Communicable Diseases, Johannesburg, South Africa, 2131
B-62 The Pathway and Expression of the Fusion Protein Von Willebrand Cleavage Protease ADAMTS13 in Human Cells C. E. Allen1 , R. Lieber1 , E. Plum1 , S. Garfield2 , S. Wincovitch2 , J. M. Newell1 , C. Kimchi-Sarfaty1 , 1CBER, FDA, Bethesda, MD, 2NCI, NIH, Bethesda, MD
B-63 The Effect of Cyclosporine A on ADAMTS13 Metalloprotease J. M. Newell1 , C. E. Allen1 , A. M. Calcagno2 , Z. E. Sauna2 , C. Kimchi-Sarfaty1 , 1CBER, FDA, Bethesda, MD, 2NCI, NIH, Bethesda, MD
B-64 Deaths due to transfusion-transmitted Klebsiella pneumoniae, 1995-2004 M. T. Niu, M. Knippen, L. Simmons, L. Holness, CBER, FDA, Rockville, MD
B-65 Comparison of 3M Petrifilm Environmental Listeria Plates with Selective Enrichment Methods for the Detection and Recovery of Listeria monocytogenes on Environmental Surfaces. J. E. Groves, D. G. Nyachuba, C. W. Donnelly, Department of Nutrition & Food Sciences, University of Vermont, Burlington, VT 05405
B-66 Development of human cell based safety evaluation assay for N. meningitidis Group B non-capsular vaccines. M. Paul-Satyaseela, S. Gudlavalleti, M. S. Blake, C. E. Frasch, M. C. Bash, CBER, FDA, Rockville, MD USA
B-67 Studies on SV40: Development of Neutralization Assays for Primate Polyomaviruses and the Isolation of New Strains of SV40 L. Sheng, R. Omeir, M. Yacobucci, M. Klutch, A. Pal, A. Lewis, K. Peden, CBER, FDA, Bethesda, MD
B-68 Translational Control of the SARS Coronavirus E. P. Plant1 , J. D. Dinman2 , D. R. Taylor1 , 1CBER, Office of Blood Research and Review, FDA, Bethesda, MD, 2CBMG, University of Maryland, College Park, MD
B-69 WEST NILE VIRUS ADHERES TO HUMAN RED BLOOD CELLS (RBC) IN WHOLE BLOOD. M. Rios1 , S. Daniel1 , S. L. Stramer2 , I. K. Hewlett1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2American Red Cross, Gaithersburg, MD
B-70 WEST NILE VIRUS NAT-POSITIVE HUMAN PLASMA CONTAINING WNV-IgM AND IgG ANTIBODIES CAN INFECT VERO CELLS AND HUMAN PRIMARY MACROPHAGES IN CULTURE. M. Rios1 , S. Daniel1 , S. L. Stramer2 , S. Caglioti3 , O. Wood1 , I. K. Hewlett1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2American Red Cross, Gaithersburg, MD, 3Blood Systems Laboratory, Tampe, AZ
B-71 Genetic Variability in West Nile Virus (WNV) Isolates From Blood Donors Specimens From 2002 - 2005 USA Epidemics A. Grinev1 , S. Daniel1 , S. L. Stramer2 , S. Caglioti3 , I. K. Hewlett1 , M. Rios1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2American Red Cross, Gaithersburg, MD, 3Blood Systems Laboratories, Tempe, AZ
B-72 Histopathological Effects of Acute Toxicity of Colchicine (COL) and Lipopolysaccharide (LPS) in Young Adult Rats. M. G. Robl1 , P. L. Wiesenfeld1 , L. H. Garthoff1 , T. J. Sobotka1 , J. K. Suagee2 , 1OARSA, CFSAN, FDA, Laurel, MD, 2University, of Maryland, College Park, MD
B-73 Application of OECD Guideline 425 (UP and Down Procedure) to Establish Dose Range for Toxicity Study M. G. Robl1 , P. L. Wiesenfeld1 , L. H. Garthoff1 , T. J. Sobotka1 , J. K. Suagee2 , 1OARSA, CFSAN, FDA, Laurel, MD, 2University of Maryland, College Park, MD
B-74 Toxicity of oral colchicine (COL) in young adult male and female rats: interactions of vehicle matrix and pre-exposure to lipopolysaccharide (LPS) P. L. Wiesenfeld1 , L. H. Garthoff1 , T. J. Sobotka1 , J. K. Suagee2 , C. N. Barton3 , 1OARSA, CFSAN, FDA, Laurel, MD, 2University of Maryland, College Park, MD, 3OSAS, CFSAN, FDA, College Park, MD
B-75 Description of aw milk-associated illnesses in the United States reported to the U.S. Food and Drug Administration (FDA), 2000-2005. M. Ross, C. Leonard, K. C. Klontz, J. Sanders, J. Sheehan, R. Childers, D. Street, CFSAN, FDA, College PArk
B-76 Moving to molecular biology-based pre-clinical vaccine safety testing: Understanding the viral genetics of mumps virus neurovirulence C. J. Sauder1 , C. X. Zhang1 , K. M. Vandenburgh1 , P. Duprex2 , K. M. Carbone1 , S. A. Rubin1 , 1FDA, Bethesda, MD, 2The Queen's University of Belfast, Belfast, UK
B-77 RNA interference in Trypanosome: A tool to study pathogenesis in Leishmania A. Selvapandiyan1 , P. Kumar2 , J. C. Morris3 , C. C. Wang2 , H. L. Nakhasi1 , 1CBER, FDA, Bethesda, MD, 2UCSF, San Francisco, CA, 3Clemson University, Clemson, SC
B-78 A NEW ANTIVIRAL PATHWAY THAT MEDIATES HCV REPLICON INTERFERON SENSITIVITY THROUGH ADAR1 D. R. Taylor1 , M. Puig2 , K. Mihalik3 , E. M. Silberstein1 , S. M. Feinstone3 , 1DETTD, CBER, FDA, Rockville, MD, 2DTP, CDER, FDA, Rockville, MD, 3DVP, CBER, FDA, Rockville, MD
B-79 Development of Plasmid DNA Vaccines Against Highly Pathogenic H5N1 Avian Influenza Viruses L. Smith, G. Jimenez, A. Geall, P. Lalor, R. Vahle, R. Planchon, Q. Wei, D. Rusalov, A. Rolland, D. Kaslow, Vical Incorporated
B-80 The adenoviral fiber shaft is a major determinant of Kupffer cell necrosis J. S. Smith1 , S. C. Stevenson2 , J. Tian1 , A. P. Byrnes1 , 1CBER, FDA, Bethesda, MD, 2Department of Diabetes and Metabolism, Novartis Institutes of Biomedical Research Inc., Cambridge, MA
B-81 Acute Toxicity of Sodium Arsenite in a Complex Food Matrix R. L. Sprando1 , T. F. Collins1 , T. N. Black1 , N. Olejnik1 , M. Ramos-Valle1 , J. I. Rorie1 , D. I. Ruggles2 , 1CFSAN,FDA, Beltsville, MD, 2CFSAN,FDA, College Park,MD
B-82 The rubella virus nonstructural protease recognizes itself via an internal sequence present upstream of the cleavage site for trans-activity H. H. Chen, C. J. Stark, C. D. Atreya, DVP, CBER, FDA, Bethesda, MD
B-83 Prevalence and Antimicrobial Resistance of Campylobacter Isolated from Retail Meat and Poultry, NARMS 2004 A. A. Stearns, L. L. English, D. G. White, P. F. McDermott, A. Walker, S. K. Hubert, S. L. Ayers, E. Hall-Robinson, T. Prescholdt, R. D. Walker, FDA, Laurel, MD
B-84 Development of a Nanoparticle-Based Bio-Bar Code Amplification (BCA)Assay for Rapid and Sensitive Detection of HIV-1 RNA and Capsid Protein (p24) S. Tang1 , J. Zhao1 , J. J. Storhoff2 , A. Dhar1 , T. Patno2 , C. A. Mirkin3 , S. Wolinsky4 , I. K. Hewlett1 , 1CBER, FDA, Bethesda, MD, 2Nanosphere Inc., Northbrook, IL, 3Northwestern Uni., Evanstone, IL, 4Northwestern Uni., Chicago, IL
B-85 Evaluation of Nanomaterials' Immunotoxicity: Example of Polystyrene Nanoparticles V. J. Tomazic-Jezic, T. H. Umbreit, M. E. Stratmeyer, FDA, CDRH, White Oak, MD
B-86 Recovery of Listeria monocytogenes from Environmental Swabs L. Zhu1 , D. Stewart2 , S. Ravishankar1 , M. Tortorello2 , 1National Center for Food Safety and Technology, Summit IL, 2FDA-CFSAN, Moffett Center, Summit IL
B-87 The identification of antibacterial compounds for the development of enhanced media for the detection of foodborne fungi V. H. Tournas1 , J. S. Kohn2 , E. J. Katsoudas2 , 1CFSAN, FDA, College Park, MD, 2NERL, FDA, Jamaica, NY
B-88 Moulds, yeasts and aerobic plate counts in medicinal herbal teas and coffee substitutes V. H. Tournas1 , E. J. Katsoudas2 , 1CFSAN, FDA, College Park, MD, 2NERL, FDA, Jamaica, NY
B-89 Enhancement of Salmonella Enteritidis isolation from shell eggs using Ferroxiamine E I. E. Valentin-Bon1 , K. H. Seo2 , R. E. Brackett2 , 1USPHS, DHHS, FDA, 2CFSAN, FDA
B-90 Medicinal Chemistry of Uncaria tomentosa, Lepidium meyenii, and Croton lechleri L. G. Valerio, Jr.1 , G. F. Gonzales2 , 1Office of Food Additive Safety, CFSAN, FDA, College Park, MD, 2Department of Biological and Physiological Sciences, Universidad Peruana Cayetano Heredia, Lima, Peru
B-91 Genetic markers of Mollicutes: The use of the 16S-23S rRNA intergenic transcribed spacer (ITS) region for detection of mycoplasma contamination and identification. D. V. Volokhov, J. George, A. A. Neverov, H. Kong, D. Chandler, C. Anderson, V. E. Chizhikov, FDA, Rockville, MD
B-92 The Hairless Guinea Pig as an Animal Model for Identifying Indirect Photosensitizers W. G. Wamer, P. K. Fu, R. R. Wei, J. C. Hubinger, CFSAN, FDA, College Park, MD
B-93 PROTECTIVE EFFECT OF MIDAZOLAM ON KETAMINE-INDUCED NEUROTOXICITY IN RAT FOREBRAIN CULTURE C. Wang1 , N. Sadovova2 , C. X. Zou1 , A. C. Scallet1 , T. A. Patterson1 , J. P. Hanig3 , M. G. Paule1 , W. Slikker1 , 1NCTR, FDA, Jefferson, AR, 2Toxicologic Pathology Associates, Jefferson, AR, 3CDER, FDA, Rockville, MD
B-94 Antimicrobial Resistance among E. coli Isolates Recovered from Retail Foods of Animal Origin, NARMS 2004 D. G. White1 , S. L. Ayers1 , A. Glenn1 , E. Hall-Robinson1 , R. D. Walker1 , T. M. Chiller2 , P. F. McDermott1 , 1CVM, FDA, Laurel, MD, 2CDC, Atlanta, GA
B-95 VEGF and anti-restenotic drugs induce a prothrombotic state in endothelial cells. S. C. Wood1 , G. S. Bushar1 , B. Tesfamariam2 , 1CDRH, Silver Spring, MD, 2CDER, Silver Spring, MD
B-96 Percutaneous Absorption of Retinol in Fuzzy Rat (In Vivo and In Vitro) and Human Skin (In Vitro) From Cosmetic Vehicles J. J. Yourick1 , C. T. Jung2 , R. L. Bronaugh1 , 1Office of Cosmetics and Colors, CFSAN, FDA, Laurel, MD, 2OPS/OGD/DBE, CDER
B-97 NITRIC OXIDE-ASSOCIATED NEPHROTTOXICITY IN JUVENILE RATS TREATED WITH GENTAMICIN J. Zhang1 , T. J. Miller1 , N. P. Clayton2 , J. P. Hanig1 , P. Espandiari1 , 1CDER, FDA, Silver Spring, MD, 2NIEHS, Research Triangle Park, NC
B-98 A PROINFLAMMATORY ROLE OF MAST CELL DEGRANULATION (MCD) IN DRUG-INDUCED VASCULAR INJURY IN SPRAGUE-DAWLEY RATS J. Zhang1 , A. D. Knapton1 , T. J. Miller1 , P. Espandiari1 , R. Anderson1 , E. H. Herman1 , R. Snyder2 , J. P. Hanig1 , J. L. Weaver1 , 1CDER, FDA, Silver Spring, MD, 2Schering-Plough Research Institute, Lafayette, NJ
B-99 Characterization Salmonella enterica serovar Heidelberg from Retail Meat Samples: National Antimicrobial Resistance Monitoring System (NARMS): 2002-2004 S. Zhao, D. G. White, S. F. Friedman, A. Glenn, S. L. Ayers, J. W. Abbott, S. K. Hubert, E. Hall-Robinson, H. C. Harbottle, R. D. Walker, P. F. McDermott, CVM, FDA, Laurel, MD
B-100 Characterization of Antimicrobial Resistance of Salmonella Isolates Recovered From Diseased Animals S. Zhao1 , P. F. McDermott1 , D. G. White1 , S. Qaiyumi1 , S. F. Friedman1 , J. W. Abbott1 , A. Glenn1 , S. L. Ayers1 , P. K. Post2 , W. H. Fales3 , R. B. Wilson4 , C. Reggiardo5 , R. D. Walker1 , 1CVM, FDA, Laurel, MD, 2Rollins Animal Disease Diagnostic Laboratory, Raleigh, NC, 3University of Missouri, VMDA, Columbia, MO, 4CE Kord Animal Laboratory, Tennessee Department of Agriculture, Nashville, TN, 5Arizona Veterinary Diagnostic Laboratory, University of Arizona, Tucson, AZ
B-PO-101 Interactive cytotoxicity of phthalate monoesters in Jurkat lymphoma cells A. D. Lucas, R. P. Brown, M. E. Stratmeyer, CDRH, FDA, Silver Spring, MD
B-PO-102 A Simple and Rapid Clinical Observational Battery (COB) for Predicting Mortality in a Small Rodent Model with Potential Application to Counter-terrorism. J. K. Suagee1 , L. H. Garthoff1 , P. L. Wiesenfeld1 , T. J. Sobotka1 , C. N. Barton2 , 1OARSA, FDA, Muirkirk Road Complex, Laurel, MD, 2OSAS, FDA, College Park, MD
B-PO-103 Solar UV doses of young Americans are inadequate for sufficient vitamin D3 production D. E. Godar1 , S. G. Coelho1 , W. B. Grant2 , M. F. Holick3 , 1CDRH, FDA, Rockville, MD, 2Sunlight, Nutrition and Health Research Center, SUNARC, San Francisco, CA 94109, 3Department of Medicine, Boston University School of Medicine, Boston, MA 02118
B-PO-104 Solar UV doses of adult Americans are inadequate for sufficient vitamin D3 production D. E. Godar1 , W. B. Grant2 , M. F. Holick3 , 1CDRH, FDA, Rockville, MD, 2Sunlight, Nutrition and Health Research Center, SUNARC, San Francisco, CA 94109, 3Department of Medicine, Boston University School of Medicine, Boston, MA 02118
B-PO-105 Campylobacter jejuni Induce Maturation and Cytokine Production in Human Dendritic Cells L. Hu, M. D. Bray, M. Osorio, D. J. Kopecko, LESTD, CBER, FDA, Bethesda, MD 20892
B-PO-106 Development of a Real Time PCR Method for the Detection of Yersinia enterocolitica in Green Leafy Vegetables A. Rodriguez1 , A. Margolin2 , 1WEAC, Winchester, MA, 2UNH, Durham, NH
B-PO-107 Evaluation of efficacy of quaternary ammonium compounds as disinfectant to inactive Enterobacter sakazakii - Preliminary Study K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD
B-PO-108 Inactivation of Enterobacter sakazakii vegetative cell to sodium hypochlorite and comparison of biofilm formation on various different conveyor belt chips K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD
B-PO-109 Multi-detection system for E. coli O157:H7 and Salmonella Enteritidis using by quantum dots as nanotechnology -Preliminary Study K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD
B-PO-110 Removal and inactivation of Bacillus anthracis spores using by various commercial disinfectants K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD
B-PO-111 Comparison of FDA method and Real-Time PCR for the detection of Enterobacter sakazakii in powdered infant formula- Preliminary Study K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD
B-PO-112 Comparison of Ct value on 10 different pre-enrichment broths to detect Enterobacter sakazakii in powdered infant formula using by Real-Time PCR- Preliminary Study K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD
B-PO-113 Devolutionary-like Changes in the Genome of a Natural Atypically Hemolytic Listeria innocua Strain Suggesting a Common Ancestor of L. monocytogenes and L. innocua. D. V. Volokhov1 , S. Duperrier2 , A. A. Neverov1 , J. George1 , R. E. Duvall3 , C. Buchrieser2 , A. D. Hitchins3 , 1FDA, Rockville, MD, 2Institut Pasteur, Paris, France, 3FDA, College Park, MD
B-114 Enterobacter sakazakii Detection During Routine Bacteriological Examination of Food Samples M. O. Paul, NRL, ORA, FDA
C-01 NMR AND MS METABOLIC PROFILES OF LIPIDS IN PLASMA FROM HUMAN PANCREATIC CANCER AND CONTROL PATIENTS R. D. Beger1 , L. K. Schnackenberg1 , R. D. Holland1 , D. Li2 , Y. P. Dragan1 , 1NCTR, FDA, Jefferson, AR, 2University of Texas, MD Anderson Cancer Center, Houston, TX
C-02 A data-based assessment of alternative strategies for identification of potential human cancer hazards A. R. Boobis1 , D. Jacobson-Kram2 , J. S. MacDonald3 , N. G. Doerrer4 , 1Imperial College London, London, UK, 2CDER, FDA, Silver Spring, MD, 3Schering-Plough Research Institute, Kenilworth, NJ, 4ILSI Health and Environmental Sciences Institute, Washington, DC
C-03 Biomarkers of early kidney injury: Kidney injury molecule-1 (Kim-1) expression in kidney and urine after acute exposure to gentamicin or mercury P. L. Goering1 , V. S. Vaidya2 , R. P. Brown1 , Z. Vakili1 , B. A. Rosenzweig3 , A. M. Johnson2 , K. L. Thompson3 , A. I. Steen1 , J. V. Bonventre2 , 1CDRH, FDA, Rockville, MD, 2Harvard Medical School, Boston, MA, 3CDER, FDA, Silver Spring, MD
C-04 Preliminary Evaluation of an Early Surrogate Marker for Successful Laser Treatment in Ovine Hyaluronidase-Treated Subjects with Diabetes and Severe Vitreous Hemorrhage E. Thomas1 , L. R. Grillone2 , T. R. McNamara2 , J. A. Gow2 , A. M. Hochberg3 , R. K. Pearson3 , 1L.A. Retina, Beverly Hills, CA, 2ISTA Pharmaceuticals®, Inc., Irvine, CA, 3ProSanos Corporation, Harrisburg, PA
C-05 Examination of the Female Sprague-Dawley Rat as a model of Rosiglitazone-Induced Toxicity E. Herman1 , A. D. Knapton1 , T. Miller1 , P. Espandiari1 , R. Anderson1 , S. Moore2 , J. P. Hanig1 , 1OPS/OTR/DAPR, 2Ciphergen Biosystems, Inc
C-06 Cdc42 as a potential therapeutic target for the reduction of cellular proliferation and migration in EGFR overexpressing breast cancer cells D. S. Hirsch, Y. Shen, W. J. Wu, DMA, OBP/OPS, CDER, FDA
C-07 Progress in Developing Imaging Biomarkers for Parkinson's Disease (PD) C. S. John, Y. M. Choi, G. Q. Mills, CDER, FDA
C-08 Role of Interleukin-4/13 Receptors as Potential Biomarkers of Disease in Human Bladder carcinoma in situ B. H. Joshi, P. Leland, F. Varricchio, S. R. Husain, R. K. Puri, CBER, FDA, Bethesda, MD
C-09 Differential Effect of Collagen and Alginate Gels on Chondrocyte Growth and Phenotype Expression D. S. Kaplan1 , V. M. Hitchins1 , P. V. Phan2 , R. Y. Au2 , M. W. Hungerford3 , C. G. Frondoza3 , 1CDRH, FDA, Rockville, MD 20850, 2Nutramax Laboratories, Edgewood, MD, 3Johns Hopkins Univ., Dept. Orthopaedic Surgery, Good Samaritan Hosp., Baltimore, MD
C-10 IN-SITU PERFUSION OF RAT MESENTERY WITH DRUGS TO EVALUATE ROLE OF MAST CELL DEGRANUALTION IN EARLY MESENTERIC VASCULAR INFLAMMATION. A. D. Knapton1 , J. Zhang1 , J. L. Weaver1 , F. D. Sistare2 , J. P. Hanig1 , 1FDA, Silver Spring, MD, 2Merck, West Point, PA
C-11 Screening for Malarial Antibodies as a Criterion to Guide Donor Deferral Policy for Malaria Risk S. Kumar1 , V. Majam1 , H. Zheng1 , B. Mahajan1 , M. Parise2 , M. Wilson2 , 1CBER, FDA, Rockville, MD, 2CDC, Atlanta, GA
C-12 Transplacental and postnatal exposure to aids drugs zidovudine (AZT) and lamivudine (3TC) increases lymphoma incidence in C3B6-trp53tm1Brd[N12]F1 transgenic mice. J. E. Leakey1 , F. W. Lee1 , S. M. Lewis1 , G. Olson2 , J. K. Dunnick3 , W. T. Allaben1 , 1OSC, 2TPA, 3900 NCTR Rd, Jefferson, AR 72079, 3NIEHS, POB 12233, Research Triangle Park, NC 27709
C-13 Detection of the C to T Polymorphism in DNA-Methyl-transferase-3B (DNMT3B) Promoter Correlates with Expression of DNMT 3B in Female Pancreatic Tumor Cells: Modulation of Expression by Indole-3-Carbinol and Gemcitabine. B. D. Lyn-Cook1 , A. Haefele2 , B. Word1 , G. J. Hammons1 , 1FDA, 2University of Arkansas at Little Rock
C-14 An operational FDG/PET-CT protocol for drug development in oncology R. P. Maguire1 , W. A. Hallett2 , 1Pfizer Global R&D, Groton, USA, 2GlaxoSmithKline, London, UK
C-15 Cytochrome c: A Non-Invasive Biomarker Of Drug-Induced Liver Toxicity T. J. Miller, P. Espandiari, J. Zhang, A. D. Knapton, J. Weaver, E. Herman, J. P. Hanig, CDER, FDA, Silver Spring, MD
C-16 Optical Properties of Nanoshells for Diagnostic Imaging A. Agrawal, J. Pfefer, CDRH, FDA, Rockville, MD
C-17 The Role of CDc42 in the Development of Human Breast Cancer Y. Shen, D. S. Hirsch, W. J. Wu, OBP, DMA, CDER, FDA
C-18 Fluorescence Imaging of Metastasis of Human Pancreatic Carcinoma in a Xenograft Model and Prolongation of Survival of Animals when Treated with IL-4 Receptor-directed Cytotoxin T. Shimamura1 , R. Royal2 , M. Kioi1 , K. Angra1 , S. R. Husain1 , R. K. Puri1 , 1CBER, FDA, Bethesda, MD, 2National Cancer Institute, NIH
C-19 Risk of Local Adverse Events by Gender Following Cardiac Catheterization D. R. Tavris1 , B. A. Gallauresi1 , S. Dey2 , R. Brindis3 , K. Mitchel2 , 1FDA, 2American College of Cardiology, 3San Francisco Kaiser Hospital
C-20 A Cost-Benefit Approach to the Regulation, Qualification and Acceptance of Biomarkers and Surrogate Endpoints S. A. Williams1 , D. E. Slavin1 , J. A. Wagner2 , C. J. Webster3 , 1Pfizer, 2Merck, 3Millenium
C-21 Use of "DNA Barcoding" to Detect Adulteration of Star Anise (Illicium verum) by Other Illicium Species A. Ottesen1 , G. C. Ziobro2 , 1JIFSAN, University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD
D-01 Scientific and Regulatory Challenges of Endocrine Disruptors: Human Food Safety Considerations M.C. Aguila, CVM, FDA, Rockville, MD
D-02 The History of Voluntary Genomic Data Submissions (VGDS) at the U.S. FDA F. W. Frueh1 , L. J. Lesko1 , A. Rudman1 , F. Goodsaid1 , S. Amur1 , J. Woodcock2 , 1CDER, FDA, White Oak, MD, 2FDA, Rockville, MD
D-03 Assessment of differential gene expression in peripheral blood mononuclear cells (PBMCs) during drug treatment in cancer patients - A Voluntary Genomic Data Submission (VGDS) Study S. Amur1 , A. Noory1 , W. Tong2 , F. Goodsaid1 , F. W. Frueh1 , 1CDER, FDA, White Oak, MD, 2NCTR, FDA, Little Rock, AK
D-04 Genomic Biomarkers in FDA-approved drug labels P. Mummaneni, S. Amur, F. Goodsaid, A. Rudman, F. W. Frueh, CDER, FDA, White Oak, MD
D-05 Pharmacogenomic Information in Drug Labels: Using a Relational Database to Integrate Genetic and Genomic Information with Chemical, Biochemical, and Clinical Information S. Amur1 , A. Rudman1 , P. Mummaneni1 , D. Bagatto2 , J. Gut2 , F. W. Frueh1 , 1CDER, FDA, White Oak, MD, 2Theragenomics Associates
D-06 A Proteomic Analysis of the Thermoregulation of Shigella Virulence Factors R. L. Bell, T. L. Williams, D. Andrezjewski, K. A. Lampel, S. M. Musser, CFSAN, FDA, College Park, MD
D-07 Free fatty acids (FFA) changes correlate with brain genomic and metabonomic markers of the 3-NPA-induced mitochondrial stress in the rat brain Z. K. Binienda1 , B. T. Thorn2 , L. K. Schnackenberg1 , R. D. Beger1 , P. P. Sapienza3 , C. S. Kim3 , S. F. Ali1 , B. D. Przybyla4 , 1NCTR, FDA, Jefferson, AR, 2Z-Tech, Co., Jefferson, AR, 3CFSAN, FDA, Laurel, MD, 4UAMS, Little Rock, AR
D-08 'Omics' Technologies Enabling the 3Rs in Drug Discovery and Development: Treating Human Disease by Studying Humans S. Dhruvakumar, PETA
D-09 Prioritizing sources of variability in genomic microarray data (OSHC inter-center project) D. G. Ranamukhaarachchi1 , D. Nandanie1 , R. Puri2 , A. X. Yang2 , J. Han2 , J. C. Fuscoe3 , T. Han3 , W. S. Branham3 , H. F. Yancy4 , H. C. Harbottle4 , J. Mason5 , S. Morris3 , W. Liggett6 , S. J. Wang7 , D. Mendrick8 , T. Martinsky9 , 1CDRH, Federal Labs at White Oak, Silver Spring MD, 2CBER, FDA, Bethesda MD, 3NCTR, FDA, Jefferson AR, 4CVM, FDA, Laurel MD, 5Howard U. Washington DC, 6CDRH/NIST, FDA, Rockville MD, 7CDER, Federal Labs at White Oak, Silver Spring MD, 8GeneLogic, 9Telechem
D-10 The National Center for Toxicological Research. ...research innovations for public health T. J. Flammang, J. F. Anson, W. Slikker, NCTR, Jefferson, AR
D-11 2D and 3D QSAR Models for Prediction of hERG K+ Channel Inhibition G. Fraczkiewicz, D. Zhuang, R. Fraczkiewicz, W. S. Woltosz, M. B. Bolger, Simulations Plus, Inc., Lancaster, CA
D-12 New empirical method obtains partial atomic charges from 2D inputs and improves some predictive ADMET models R. Fraczkiewicz, G. Fraczkiewicz, M. B. Bolger, W. S. Woltosz, Simulations Plus, Inc.; 42505 10th Street West, Lancaster, CA 93534
D-13 Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model (OWH Project) J. C. Fuscoe1 , R. D. Beger1 , W. S. Branham1 , R. R. Delongchamp2 , Y. P. Dragan1 , P. H. Duffy3 , R. D. Edmondson1 , T. Han1 , D. K. Hansen3 , R. D. Holland1 , R. C. Jones1 , C. L. Moland1 , L. K. Schnackenberg1 , J. T. Taylor1 , W. Tong1 , 1Division of Systems Toxicology, NCTR, FDA, Jefferson, AR, 2Division of Biometry and Risk Assessment, NCTR, FDA, Jefferson, AR, 3Division of Genetic and Reproductive Toxicology, NCTR, FDA, Jefferson, AR
D-14 Quality Prediction of Cell Substrate Using Gene Expression Profiling J. Han1 , R. L. Farnsworth2 , J. L. Tiwari1 , J. Tian1 , H. Lee1 , P. Ikonomi2 , A. P. Byrnes1 , J. L. Goodman1 , R. K. Puri1 , 1CBER, FDA, Bethesda, MD, 2ATCC, Manassas, VA
D-15 Optimization of hybridization and washing conditions to improve the reproducibility and accuracy of DNA microarray quantification T. Han, C. D. Melvin, L. Shi, W. S. Branham, P. S. Pine, K. L. Thompson, J. C. Fuscoe, FDA
D-16 Drug-metabolizing enzymes: Evidence for clinical utility of pharmacogenomic tests T. Andersson1 , D. A. Flockhart2 , D. B. Goldstein3 , S. M. Huang4 , D. L. Kroetz5 , P. M. Milos6 , M. J. Ratain7 , K. Thummel8 , 1AstraZeneca, 2Indiana University, 3Duke University, 4CDER, FDA, Silver Spring, MD, 5UCSF, 6Pfizer, 7University of Chicago, 8University of Washington
D-17 Insights into the mutator phenotype: Global gene expression in MMR-defective Salmonella enterica using DNA microarrays I. R. Patel, S. A. Jackson, J. E. LeClerc, T. A. Cebula, CFSAN, FDA, Laurel, MD
D-18 A tiling DNA microarray designed to identify and discriminate among individual isolates of Escherichia coli: Applications for array-based MLST and novel SNP discovery S. A. Jackson, I. R. Patel, M. K. Mammel, J. E. LeClerc, T. A. Cebula, CFSAN, FDA, Laurel, MD
D-19 Microarray based detection and identification of foodborne viruses B. B. Goswami, M. Ayodeji, M. Kulka, T. A. Cebula, S. A. Jackson, I. R. Patel, M. Mammel, D. Ngo, CFSAN, OARSA, FDA, Laurel, MD
D-20 Optical mapping whole chromosomes of E. coli O157:H7 reveals large chromosomal inversions and genome differences at prophage sites: Implications for individual strain identification M. L. Kotewicz1 , S. A. Jackson1 , W. Jiang2 , J. Henkhaus2 , A. Briska2 , C. W. Dykes2 , J. E. LeClerc1 , T. A. Cebula1 , 1CFSAN, FDA, Laurel MD, 2OpGen Inc. Madison WI
D-21 Genomic comparisons of antibiotic susceptible and resistant Salmonella Newport strains M. K. Mammel, J. E. LeClerc, T. A. Cebula, DMB, OARSA, CFSAN, FDA, Laurel, MD
D-22 Development of a QSAR Weight of Evidence Model for Reproductive and Developmental Toxicity Hazard Identification E. J. Matthews, N. L. Kruhlak, R. D. Benz, J. F. Contrera, CDER, FDA, Silver Spring, MD
D-23 Structure Activity Relationship Analysis Tools: Validation and Applicability J. Mayer, M. Cheeseman, M. L. Twaroski, CFSAN, FDA, College Park, MD
D-24 Importance of Data Filtration in the Analysis of Voluntary Genomic Data Submission (VGDS) data - An Example A. Y. Men, S. Amur, F. Goodsaid, F. W. Frueh, CDER, FDA, Silver Spring, MD
D-25 Development of Microarray Standards and Procedures for Analyzing Clinical Samples A. D. Nandanie1 , S. Lababidi2 , R. K. Panguluri1 , M. Schneider1 , D. G. Ranamukhaarachchi1 , 1DB, OSEL, CDRH, FDA, 2DB, OSB, CDRH, FDA
D-26 Metabonomics Applied to a Rodent Pediatric Nephrotoxicity Model L. K. Schnackenberg1 , P. Espandiari2 , J. Zhang2 , P. S. Pine2 , R. Anderson2 , R. D. Beger1 , J. P. Hanig2 , 1NCTR, FDA, Jefferson, AR, 2CDER, FDA, Silver Spring, MD
D-27 Oligo Design: Software for DNA Sequence Analysis including PCR Primer and Microarray Probe Design N. Sergeev1 , A. Rasooly2 , K. Herold3 , 1FDA/CDRH/OSEL/DB, Silver Spring, MD, 2NIH-National Cancer Institute, Rockville, MD, 3UMD- University of Maryland, College Park, MD
D-28 Molecular Characterization of the Canine Factor VIII Gene and Duplicated Sequences Related to a Common Gene Inversion Mutation N. Tayebi, L. Wood, J. N. Lozier, CBER, FDA, Rockville, MD
D-30 Characterization of Alterations in Rat Liver Microarray Data Induced by Tissue Handling P. S. Pine1 , B. A. Rosenzweig1 , Y. Turpaz2 , K. L. Thompson1 , 1CDER, FDA, Silver Spring, MD 20993, 2Affymetrix Inc., Santa Clara, CA 95051
D-31 Evaluation of the Age-Dependent Nephrotoxicity of Gentamicin Using Gene Expression Biomarkers. B. A. Rosenzweig, K. L. Thompson, J. Zhang, J. P. Hanig, P. Espandiari, CDER, FDA, Silver Spring, MD 20993
D-32 The Global Ratio as a Quality Control Metric for Microarray Data C. Alvares1 , M. A. Kuziora1 , P. S. Pine2 , K. L. Thompson2 , 1Gene Logic, Gaithersburg, MD 20879, 2CDER, FDA, Silver Spring, MD 20993
D-33 A Baseline Animal Microarray Database for Biological Response Identification and Biomarker Validation J. Fostel1 , K. L. Thompson2 , M. Cooper3 , S. Pettit4 , 1NCT, NIEHS ITSS, Research Triangle Park, NC, 2CDER, FDA, Silver Spring, MD, 3Biogen Idec, Cambridge, MA, 4HESI, Washington, DC
D-34 Genetic Associations in Clinical Trials: Some Issues in Design and Analysis J. L. Tiwari, R. K. Puri, B. Zaslavsky, CBER, FDA, Rockville, MD
D-35 NCTR Center for Toxicoinformatics - A Bioinformatics Resource for Genomics, Proteomics, Metabolomics and Predictive Toxicology W. Tong1 , L. Shi1 , S. Harris1 , M. Bishop1 , H. Fang2 , H. Hong2 , Q. Xie2 , H. Sun2 , M. Cao2 , F. Ranamukhaarachchi2 , R. Perkins2 , 1NCTR, FDA, 2Z-tech
D-36 Comparison of Artificial Neural Network and Support Vector Machine Ensemble Models D. Zhuang, R. Fraczkiewicz, W. S. Woltosz, M. B. Bolger, Simulations Plus Inc., 42505 10th Street West, Lancaster, CA, 93534
D-38 Sex Differences in CYP3A Activity Using Intravenous and Oral Midazolam M. Chen, L. Ma, G. L. Drusano, J. S. Bertino, Jr., A. N. Nafziger, Ordway Research Institute, Albany, NY 12208
D-PO-37 The E. coli lac operon: Why? R.L. Bernstein, FDA, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070
E-01 Effect of a Potent CYP3A Inhibitor Ketoconazole on Interindividual Variability of CYP3A Activity as Measured by Oral Midazolam M. Chen, A. N. Nafziger, J. S. Bertino, Jr., Ordway Research Institute Drug Development Center, Ordway Research Institute, Albany, NY 12208
E-02 Exposure-Response Relationship for an Anti-Infective in an Animal Infection Model versus Patients C. R. Bonapace1 , V. R. Jarugula1 , B. Green2 , J. V. Gobburu1 , 1CDER, FDA, Silver Spring, MD, 2School of Pharmacy, University of Queensland, Brisbane, Australia
E-03 Excel and Visual Basic software can be used to develop a physiologically-based pharmacokinetic (PBPK) model for ethylene oxide K. Herold1 , R. P. Brown2 , M. E. Stratmeyer2 , 1University of Maryland, College Park, MD, 2CDRH, FDA, Silver Spring, MD
E-04 Comparison of Bovine In Vivo Bioavailability of Two Sulfamethazine Oral Boluses Exhibiting Different In Vitro Dissolution Profiles. M. N. Martinez1 , J. C. Kawalek2 , K. D. Howard2 , J. L. Ward2 , P. Marroum3 , W. G. Marnane1 , D. M. Bensley1 , F. R. Pelsor1 , S. W. Hoag4 , A. S. Tatavarti4 , L. Xie4 , R. M. Fahmy1 , 1CVM, FDA, Rockville, MD, 2CVM, OR, Laural, MD, 3CDER, FDA, Silver Spring, MD, 4University of Maryland
E-05 PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR THE INHIBITION OF MIDAZOLAM CLEARANCE BY ERYTHROMYCIN AND DILTIAZEM X. Zhang1 , J. C. Gorski2 , S. M. Huang3 , A. Lucksiri2 , J. Y. Chien4 , S. K. Quinney2 , D. R. Jones2 , S. D. Hall2 , 1Purdue University, West Lafayette, IN, 2Indiana University, Indianapolis IN, 3CDER, FDA, Rockville MD, 4Eli Lilly & Co, Indianapolis IN
E-06 Simulation of Midazolam Absorption and Bioavailability in Pediatric Patients V. Lukacova, W. S. Woltosz, M. B. Bolger, Simulations Plus, Inc., Lancaster, CA
E-07 Epidemiological cut-off values for four antimicrobial agents against Aeromonas salmonicida isolates using MIC and zone diameter frequency distributions R. A. Miller, R. D. Walker, R. Reimschuessel, CVM, FDA, Laurel, MD
E-08 Pharmacokinetics of Gabapentin Injection in Cerebrospinal Fluid and Plasma with Intrathecal Administration R. J. Sawchuk1 , L. M. Page2 , R. L. Rauck3 , 1University of Minnesota, College of Pharmacy, Minneapolis, MN 55455, 2Medtronic Neurological, Minneapolis, MN 55432, 3Carolinas Pain Institute, Winston-Salem, NC 27103
E-09 Improving Pediatric Dosing Through Pediatric Initiatives - What We Have Learned W. J. Rodriguez, A. Selen, D. Avant, C. Chaurasia, T. Crescenzi, G. Gieser, J. DiGiacinto, S. M. Huang, P. Lee, L. Mathis, D. Murphy, S. Murphy, R. Roberts, H. C. Sachs, S. Suarez, V. Tandon, R. S. Uppoor, J.A. Lazor, L.J. Lesko and D. M. Chilukuri, CDRH, FDA
E-10 Parameter Sensitivity Analysis and Virtual Trial of Oral Cyclosporine Capsule P. M. Sathe1 , V. A. Sayeed1 , L. X. Yu1 , M. B. Bolger2 , 1OGD, CDER, FDA, Rockville, MD, 2Simulations Plus Inc, Lancaster, CA
E-11 Metabolism and residue depletion of [3]H-ivermectn in the muscle tissue of rainbow trout after oral administration B. Shaikh, N. G. Rummel, C. Gieseker, R. Reimschuessel, FDA/CVM, Laurel, MD
E-PO-12 Distribution of Androstenedione and Its Related Steroids in Pregnant Rats I. A. Ross, P. P. Sapienza, W. D. Johnson, R. L. Sprando, K. R. O'Neill, S. C. Sahu, T. J. Flynn, T. F. Collins, P. L. Wiesenfeld, C. S. Kim, CFSAN, Laurel, MD
F-01 STEALTH NANOPARTICLES FOR THE FABRICATION OF DRUG DELIVERY DEVICES E. O. Akala, O. Okunola, Howard University, Washington, DC
F-02 A Multiplex PCR Microarray Assay for Screening Blood R. Duncan, C. A. Cadogan, K. Tomioka, A. Selvapandiyan, K. Stabler, J. Mellquist-Riemenschneider, D. V. Volokhov, V. E. Chizhikov, H. L. Nakhasi, CBER, FDA, Bethesda, MD
F-03 Analysis of Oligomeric Organosilsesquioxanes by MALDI-TOF Mass Spectrometry M. Farahani1 , J. M. Antonucci2 , C. M. Guttman2 , W. E. Wallace2 , 1CDER, FDA, Rockville, MD, 2NIST, Gaithersburg, MD
F-04 Development of a Novel Technology to Measure Impaction Force of Nasal Sprays and Metered-Dose Inhalers Using the Texture Analyser C. Guo, W. H. Doub, DPA, CDER, FDA, St. Louis, MO
F-05 Simple confocal microscopy based on single hollow-core photonic bandgap fiber D. H. Kim1 , J. U. Kang1 , R. Waynant2 , I. K. Ilev2 , 1Johns Hopkins University, Baltimore, MD, 2CDRH, FDA, Rockville, MD
F-06 Characterizing Reflections from Intraocular Lens Implants R. J. Landry, I. K. Ilev, T. J. Pfefer, R. W. Faaland, D. Calogero, CDRH, FDA, Rockville, MD
F-07 Establishment of design space for a modified-release Zidovudine microsphere dosage form D. R. Lu1 , K. Abu-Izza2 , 1ONDQA, CDER, FDA, 2University of Georgia
F-08 A new robotic approach for high-throughput screening of unique Trazodone salts D. R. Lu1 , E. C. Ware2 , 1ONDQA, CDER, FDA, 2University of Georgia
F-09 New lipoprotein mimics as novel nanoscale DNA vaccine delivery carriers D. R. Lu1 , F. Alanazi2 , Z. Fu2 , 1ONDQA, CDER, FDA, 2University of Georgia
F-10 Evaluation of platelet activation in medical devices Q. Lu, R. Malinauskas, S. F. Stewart, CDRH, FDA, Rockville, MD
F-11 Reversal of Chronic Hypotension by Non-Invasive Plantar Stimulation G. Madhavan, K. J. McLeod, Clinical Science and Engineering Research Center, State University of New York, Binghamton, New York
F-12 Optimization of cyclosporine A self-nanoemulsified drug delivery systems using Box-Behnken design and desirability function A. S. Zidan1 , M. A. Habib2 , A. NguyenPho3 , M. A. Khan4 , 1DPQR, CDER, FDA, Silver Spring, MD & School of Pharmacy, Howard University, Washington, DC, 2School of Pharmacy, Howard University, Washington, DC, 3DPQR, CDER, FDA, Silver Spring, MD, 4DPQR, CDER, FDA, Siver Spring, MD
F-13 Micro Structure Development and Release Behavior in Controlled Drug Delivery Systems D. M. Saylor1 , M. K. McDermott1 , B. J. Dair1 , C. S. Kim1 , J. Toy2 , D. V. Patwardhan1 , J. A. Warren3 , 1OSEL,CDRH,FDA, Rockville, MD, 2ODE,CDRH,FDA, Rockville, MD, 3NIST, Gaithersburg, MD
F-14 Effect of Materials Selection in Controlled Drug Delivery Systems: (Bio)Degradable v. Non-Degradable Polymers D. M. Saylor1 , M. K. McDermott1 , B. J. Dair2 , J. Toy1 , D. V. Patwardhan1 , J. A. Warren3 , 1OSEL,CDRH,FDA, Rockville, MD, 2ODE,CDRH,FDA, Rockville, MD, 3NIST, Gaithersburg, MD
F-15 In Vitro Characterization of Fentanyl Transdermal Systems S. Prodduturi, A. M. Wokovich, B. J. Westenberger, L. F. Buhse, W. H. Doub, DPA, OTR, CDER, FDA, St. Louis, MO
F-16 Vacuolar Growth in Foldable IOLs: Toward a Preclinical Test S. Salas-Vega, D. C. Richardson, CDRH, FDA, Rockville, MD
F-17 Modeling Time-dependent and Cycle-dependent Capacity Fade in Rechargeable Lithium-ion Batteries in an Implantable Neurostimulator E. Scott, A. Crespi, C. Schmidt, Medtronic, Inc.
F-18 Formulation, Evaluation and Progress of Emulsion Formation of an Alternative Self-Nanoemulsified Drug Delivery System of Cyclosporine A A. S. Zidan1 , M. A. Habib2 , O. A. Khan3 , R. B. Shah4 , 1Visiting Student, DPQR, CDER, FDA, SIlver spring, MD. School of Pharmacy, Howard University, Washington DC., 2School of Pharmacy, Howard University, Washington DC, 3Summer intern, OPS, CDER, FDA, Silver spring, MD, 4DPQR, CDER, FDA, Silver spring, MD
F-19 Physical Properties of Abdominal Adhesion Barriers K. Vorvolakos, H. D. Luu, D. V. Patwardhan, I. S. Isayeva, S. K. Pollack, FDA-CDRH-OSEL-DCMS
F-20 The Effects of Position with Respect to the Heart on Pulse Oximetry Measurements S. Weininger1 , A. B. Shang2 , 1CDRH, 2Duke Univerisity
F-PO-21 Disulfide bonds do not influence proteolytic digestion patterns of alpha-1-PI polymers* E. Marszal, R. A. Boykins, A. Shrake, CBER, FDA, Bethesda, MD 20892
F-22 Synthesis and Characterization of an Iron-Crosslinked Hyaluronic Acid-Based (FeHa) Adhesion Barrier I. Isayeva1, H.D. Luu1, J. DeFoe2, D. Patwardhan1, A. Chen3, K. Vorvolakos1, and S.S. Das1, 1Division of Chemistry and Materials Science, Office of Science and Engineering Laboratories, CDRH/FDA, Rockville, MD 20852, 2Department of Chemistry, Marquette University, Milwaukee, WI 53233, 3Thomas S. Wootton High School Rockville, MD 20850
G-01 Coding of Indicator Variables When There Is an Interaction Term. A Cautionary Tale. P. E. Bonangelino, E. Russek-Cohen, CDRH, FDA, Rockville, MD
G-02 Emerging Trends in Clinical Trial Data Integration and Management P. Chakraborty, S. Nagaraja, Cognizant Technology Solution
G-03 Crossover Designs for Drug Abuse potential Clinical Trials L. Chen, Y. Tsong, CDER, FDA, White Oak, MD
G-04 Comparing Diagnostic Sensitivities With a Doctor in the Loop B. D. Gallas1 , G. A. Pennello2 , 1OSEL/CDRH/FDA Rockville MD, 2OSB/CDRH/FDA Rockville MD
G-05 Conservative or anti-conservative?: ITT and PP approach in RCT Y. Gao, L. Thompson, FDA
G-06 Estimating the Relative Efficiency of Odds Ratio Estimates by the Bootstrap Technique P. T. Liu, Q. F. Graves, CFSAN
G-07 Toward an integrated analysis of risk and benefit in clinical research S. Hirschfeld, CBER FDA, Rockville, MD
G-08 Calculation of Z Values for a Phase 1 Alanine Aminotransferease Data Set G. F. Kapke, J. Leroux, Covance Central Laboratory Services, Indianapolis, IN
G-09 Gender-specific statistical models of pathological coronary arteries for generating simulated angiograms I. S. Kyprianou1 , L. Thompson2 , D. Banh1 , W. Pritchard3 , J. Karanian4 , L. Rosen5 , K. J. Myers1 , 1NIBIB/CDRH Joint Laboratory for the Assessment of Medical Imaging Systems, US Food and Drug Administration, Rockville, MD, USA, 2OSB/DBS/CODB, Rockville, MD, USA, 3OSEL/DSFM, Rockville, MD, USA, 4OSEL/DB, Rockville, MD, USA, 5NIH/CSR, Bethesda MD
G-11 Statistical Considerations in the Evaluation of RBC Products T. Ng1 , P. He2 , J. Kim1 , P. Hshieh1 , 1CBER, FDA, Rockville, MD, 2CBER, FDA, Bethesda, MD
G-12 Can "Weight Only" Method be Used to Determine the Post-Filtration Red Blood Cell In Vitro Recovery for Quality Control Validation? T. Ng1 , B. J. Poindexter2 , J. G. Vostal2 , P. He2 , 1CBER, FDA, Rockville, MD, 2CBER, FDA, Bethesda, MD
G-13 Frequentist and Bayesian are Complementing Each Other T. Ng, CBER, FDA, Rockville, MD
G-14 Simultaneous Testing of Noninferiority and Superiority increases the False Discovery Rate T. Ng, CBER, FDA, Rockville, MD
G-15 Comparing Image Detection Algorithms using Resampling F. W. Samuelson, N. Petrick, CDRH, FDA, Rockville, MD
G-16 Interchangeability of the two measurement systems of the anthrax vaccine potency: Toxin Neutralization Assay and ELISA. L. A. Sirota1 , B. G. Zaslavsky1 , P. M. Parreiras2 , L. D. Wagner1 , S. L. Menzies1 , J. L. Arciniega1 , 1CBER, FDA, Rockville MD 20852, 2NIQCH, Rio de Janeiro, RJ 21.040-900 - Brazil
G-17 ON ESTIMATION OF THE PROPORTION OF TREATMENT BENEFIT WITH A CONTINUOUS RESPONSE WITHOUT DICHOTOMIZATION Y. Tsong, CDER, FDA, Silver Spring, MD
G-18 DEPENDENCY OF NON-INFERIORITY TRIALS J. Zhang, Y. Tsong, CDER, FDA, Silver Spring, MD
G-19 SEQUENTIAL ADAPTIVE SAMPLE SIZE RE-ESTIMATION FOR PAIR-MATCHED BINARY DATA Y. Tsong, CDER, FDA, Silver Spring, MD
G-20 AN ALTERNATIVE APPROACH TO ASSESS EXCHANGEABLILITY OF A NEW TEST TREATMENT Y. Tsong, M. Shen, CDER, FDA, Silver Spring, MD
G-21 Non-inferiority testing with a variable margin Z. Zhang, CDRH, FDA, Rockville, MD
G-22 Statistical Considerations for Lot Release Sampling Procedures B.A. Zhen, CBER, FDA, Rockville, MD
G-PO-23 Issues of a Thorough QT/QTc study J. Zhang, CDER, FDA, White Oak
H-01 PAT for Monitoring the Blend Homogeneity of an Active in a Tumble Mixer: Feasibility Studies and Real Time Experience. M. Ashraf1 , R. Chatpalli1 , M. A. Mahmud1 , A. Nagi1 , L. Sivieri2 , 1Wyeth Research, Pearl River, NY, 2Wyeth Pharma, Collegeville, PA
H-02 Control of Particle Size Distribution using PAT S. Bhansali, J. Liang, S. S. Deshmukh, Wyeth Research
H-03 ReactIR as a PAT Tool for the Online Reaction Monitoring of a Boronate Intermediate in the Manufacture of Temsirolimus W. Chew1 , W. McMahon2 , C. C. Shaw1 , 1Preclinical Development, Wyeth Research, Montreal, Canada, 2Preclinical Development, Wyeth Research, Pearl River, NY
H-04 PAT tools for evaluation of drug substance crystallization S. S. Deshmukh1 , M. Mirmehrabi2 , 1Wyeth Research, 2Wyeth Canada
H-05 The Impact of Segregation on Spectroscopic Process Measurements B. J. Ennis1 , C. D. Ellison2 , M. L. Hamad2 , A. S. Carlin2 , E. H. Jefferson2 , R. C. Lyon2 , 1E&G Associates, Nashville, TN 37215, 2DPQR, CDER, FDA, Silver Spring, MD, 20993
H-06 Characterizing the Impact of Wall and Powder Friction on Tablet Uniformity as Measured by Shear Cell and Chemical Imaging B. J. Ennis1 , C. D. Ellison2 , M. L. Hamad2 , E. H. Jefferson2 , R. C. Lyon2 , 1E&G Associates, Nashville, TN 37215, 2DPQR, CDER, FDA, Silver Spring, MD
H-07 Process Analytical Technology and Rapid Microbiological Methods using the Chemunex Scan RDI M. Farris1 , A. McDaniel2 , 1Wyeth Research, 2Wyeth Biopharma
H-08 Monitoring of manufacturing changes and formulation excipients on solid oral dosage forms of furosemide using chemometrics and laser-induced breakdown spectroscopy (LIBS) F. R. Doucet1 , L. St-Onge1 , M. Tourigny2 , M. Sabsabi1 , R. C. Lyon3 , P. J. Faustino3 , 1National Research Council of Canada, Boucherville, Canada, 2Pharma Laser, Boucherville, Canada, 3Division of Product Quality Research, Office of Pharmaceutical Science, CDER, FDA
H-09 Thermal Effusivity Application as a PAT Tool to Monitor and Control Roller Compaction Processes M. K. Ghorab, R. Chatpalli, S. Hasan, A. Nagi, Solids-Pharmaceutical R&D, Chemical and Pharmaceutical Development, Wyeth Research, Pearl River, NY 10965
H-10 Residual Solvent Drying Endpoint Detection Using Process Mass Spectrometry W. Chew, G. Glasier, E. Fournier, L. Karim, Wyeth Research, Montreal, Canada
H-11 Use of Raman imaging for determination of the particle size distribution (PSD) of active pharmaceutical ingredients (APIs) in metered-dose inhalers (MDI) C. Guo, W. H. Doub, DPA, CDER, FDA, St. Louis, MO
H-12 Imaging-Based Algorithms for Determining the Uniformity of Drug Products and Blends M. L. Hamad, C. D. Ellison, A. S. Carlin, E. H. Jefferson, M. A. Khan, R. C. Lyon, DPQR, CDER, FDA, Silver Spring, MD
H-13 Near-infrared Transflectance Spectroscopy for the Quantitative Assessment of Gabapentin Concentration in Aqueous Solution M. Durette1 , S. Kislalioglu2 , M. L. Hamad3 , A. NguyenPho3 , M. A. Khan3 , 1DPQR, CDER, FDA, Silver Spring, MD & Department of Pharmacy, University of Rhode Island, Kingston, RI, 2Department of Pharmacy, University of Rhode Island, Kingston, RI, 3DPQR, CDER, FDA, Silver Spring, MD
H-14 Application of NIR Spectroscopy for the Monitoring of Tablet Coat Thickness and Prediction of Drug Release from Different Acrylate Copolymers S. Hassannejad Tabasi1 , R. M. Fahmy2 , D. M. Bensley2 , W. G. Marnane2 , S. W. Hoag1 , 1School of Pharmacy, University of Maryland, Baltimore, MD 21201, 2Office of New Animal Drug Evaluation, FDA, Rockville, MD 20855
H-15 Development of a Chemometric Model to Evaluate Prussian Blue Product Quality using Near-Infrared Spectroscopy E. H. Jefferson, M. L. Hamad, Y. S. Yang, R. B. Shah, A. S. Carlin, R. C. Lyon, P. J. Faustino, DPQR, CDER, FDA, Silver Spring, MD
H-16 On-line particle size analysis for a roller compaction process S. Singh, M. Krishnan, A. Nagi, Wyeth Research, Pearl River, NY
H-17 Process Monitoring of Pilot-Scale Pharmaceutical Blends: FDA-Pfizer CRADA Study R. C. Lyon1 , S. Hammond2 , 1DPQR, CDER, FDA, Silver Spring, MD, 2Pfizer, Inc,, Peapack, NJ
H-18 PAT: Prediction of porosity, hardness, and content of metoprolol tartrate tablets by chemometric analysis R. B. Shah1 , M. A. Tawakkul1 , H. R. Prasanna1 , M. White2 , M. A. Khan1 , 1DPQR, CDER, FDA, Silver spring, MD, 2Sherwood High school, Sandy spring, MD
H-19 Acoustic Viscometry of Topical Preparations J. A. Spencer, R. E. Kolinski, Div. Pharmaceutical Analysis
H-20 Terahertz Spectroscopy for Pharmaceutical PAT Applications: Optimizing Measurement Process Conditions H. Wu1 , E. J. Heilweil2 , A. S. Hussain3 , M. A. Khan1 , 1Division of Product Quality Research, OTR/OPS/CDER, FDA, Silver Spring, MD, 2Optical Technology Division, Physics Laboratory, NIST, Gaithersburg, MD, 3Global Biopharmaceutical Development, Sandoz, Princeton, NJ
H-21 Terahertz Spectroscopy for Pharmaceutical PAT Applications: Quantification Methods for Studying Theophylline Tablet Compositions H. Wu1 , E. J. Heilweil2 , A. S. Hussain3 , M. A. Khan1 , 1Division of Product Quality Research, OTR/OPS/CDER, FDA, Silver Spring, MD, 2Optical Technology Division, Physics Laboratory, NIST, Gaithersburg, MD, 3Global Biopharmaceutical Development, Sandoz, Princeton, NJ
H-22 Regulatory and Engineering Considerations for Multivariate Modeling of Tablet Dissolution H. Wu, M. A. Khan, R. C. Lyon, Division of Product Quality Research, OTR/OPS/CDER, FDA, Silver Spring, MD
H-23 Using an Experimental Design Approach to Study the Statistical Relationship between Formulation Parameters, Process Parameters, and Capsule Weight Variation in Capsule Filling on Two Types of Automatic Machines L. Xie1 , H. Wu2 , L. L. Augsburger1 , M. A. Khan2 , A. S. Hussain3 , S. W. Hoag1 , 1School of Pharmacy, University of Maryland, 20 N. Pine Street, Baltimore, MD 21201, 2Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research, Office of Pharmaceutical Science, CDER, FDA, Silver Spring, MD 20993, 3Global Biopharmaceutical Development, Sandoz, Princeton, NJ 08540
H-24 Applications of Conventional and Environmental Scanning Electron Microscopy (SEM/ESEM) in Pharmaceutical Development J. Liang, Y. Xu, Y. Chen, J. Huang, W. Dulin, M. Tesconi, S. Ku, Wyeth Research
I-01 THE CREATION OF CONSOLIDATED FDA DATABASES AND THE DEVELOPMENT OF REAL-TIME DATA ENTRY TO SUPPORT STRUCTURE ACTIVITY RELATIONSHIP APPROACHES IN HAZARD IDENTIFICATION AND RISK ASSESSMENT K. B. Arvidson1 , R. D. Benz2 , E. J. Matthews2 , J. Mayer1 , E. Lee1 , M. L. Twaroski1 , C. Yang3 , 1CFSAN/OFAS, 2CDER/OPS/ICSAS, 3Leadscope, Inc.
I-02 Egg Allergy: An Assessment of the Health Hazard S. A. Assimon, P. M. Bolger, CFSAN, FDA, College Park , MD
I-03 Use of a Free, Publicly-Accessible Data Source to Estimate Hospitalizations Related to Adverse Medical Device Events. R. A. Bright, J. C. Shen, CDRH, FDA, Rockville, MD
I-04 MedWatch reporting of death, sudden death, and cardiovascular events in association with stimulants used in the treatment of ADHD over a recent 5-year period K. Gelperin, A. D. Brinker, M. I. Avigan, FDA
I-05 Risk of TSE transmission from reprocessed neurosurgical instruments is low R.P. Brown, CDRH, FDA, Silver Spring, MD
I-06 Aggregate safety assessment for co-exposure of patients to DEHP and MEHP released from PVC medical devices R. P. Brown1 , R. Ito2 , M. E. Stratmeyer1 , 1CDRH, FDA, Silver Spring, MD, 2Hoshi University, Tokyo, Japan
I-07 Effect of sterilization process on the formation of mono(2-ethylhexyl) phthalate (MEHP) from di(2-ethylhexyl) phthalate (DEHP) R. Ito, N. Miura, M. Kawaguchi, K. Saito, H. Nakazawa, Hoshi University, Tokyo, Japan
I-09 Variation in Salmonella Serotype Distributions and Antibiotic Susceptibility Profiles with Environmental Source of the Isolates D. D. Wagner, P. J. Carter, OR, CVM, Laurel, MD
I-10 An Assessment of the Cancer Risk of Ochratoxin-A, a Fungal Toxin and Food Contaminant H. A. Clark, S. M. Snedeker, Sprecher Institute for Comparative Cancer Research, Cornell University
I-11 Risk-Informed Decision Support for Pre-Approval Inspection (PAI) Decisions H. G. Claycamp, C. W. Gray, FDA, Rockville, MD
I-12 Risk Factors for Animal Drug and Feed Products, Manufacturing Processes and Facilities: Analysis of Recalls, 2000 - 2005 V. Wiles, E. A. Grove, K. B. Ekelman, CVM, FDA, Rockville, MD
I-13 Trends in outpatient prescription usage in the U.S., 2002 - 2005 K. C. Worthy, L. A. Governale, DSRCS, ODS, CDER, Silver Spring, MD
I-14 Effect of Repackaging on Gabapentin Capsules A. B. Ciavarella1 , S. Jenney1 , A. Gupta1 , P. J. Faustino1 , B. Rothman2 , M. A. Khan1 , 1DPQR, CDER, FDA, Silver Spring, MD, 2OC, FDA, Rockville, MD
I-15 SMART Review Templates placing review resources at your fingertips: What are they and how do they work? K. Hollinger1 , E. Pinnow1 , A. Oliva2 , P. Hepp3 , G. Gensinger4 , H. Chazin2 , L. Pauls5 , D. Goldman6 , J. Ware7 , K. Uhl1 , 1OWH/OSHC, 2OND, 3OCPB, 4OBPS/RRSS, 5OEP/QAS, 6Global Net Services, Inc., 7OEP
I-16 Risk Analysis of Transdermal Drug Delivery Systems (TDDSs) M. Kakhi1 , B. M. Ayyub2 , A. M. Wokovich3 , S. Prodduturi3 , W. H. Doub3 , L. F. Buhse3 , A. S. Hussain4 , N. Sadrieh1 , 1CDER, FDA, Silver Spring, MD, 2University of Maryland, College Park, MD, 3CDER, FDA, St. Louis, MO, 4Formerly CDER, FDA, Rockville, MD
I-18 Adherence to Metoclopramide Duration of Use Recommendation: Claims Data Study S. Kaplan, J. Staffa, G. Dal Pan, CDER, FDA, Silver Spring, MD
I-19 Alpha-1 Proteinase Inhibitor (Human) Product Postmarketing Safety Surveillance T. Khoie, K. A. O'Connell, R. L. Pierce, A. Shrake, C. E. Zinderman, R. P. Wise, CBER, FDA, Rockville, MD
I-20 INVESTIGATION OF SIMIAN FOAMY RETROVIRUS TRANSMISSION BY BLOOD IN RHESUS MACAQUES D. Kumar, A. S. Khan, CBER, FDA, Bethesda, MD
I-22 Live Microbial Ingredients in Dietary Supplements D. D. Levy, L. S. Pellicore, S. J. Walker, CFSAN, FDA, College Park, MD
I-23 Improving Interagency Communication on Food Safety: Interagency Risk Assessment Consortium W. R. Long, M. D. Miliotis, R. L. Buchanan, CFSAN, FDA, College Park, MD
I-24 CDER's Drug Safety Oversight Board M. Mease, T. Nearing-Crowley, L. Zwanziger, S. Cummins, CDER, FDA, Rockville, MD
I-25 Blood use patterns among U.S. elderly during 2001 M. Menis, D. R. Burwen, K. A. O'Connell, S. A. Anderson, CBER, FDA, Rockville, MD
I-26 Benchmark Dose Analysis of in vivo Genotoxicity Data Can be Used to Inform Cancer Risk Assessment M. Moore1 , B. Allen2 , M. Dourson3 , L. Haber3 , R. Heflich1 , R. Kodell1 , A. Shipp4 , 1NCTR, FDA, Jefferson, AR, 2Bruce Allen Consulting, 3Toxicology Excellence for Risk Assessment, 4ENVIRON International, Ruston, LA
I-27 Bleeding complication associated with patients on warfarin treated at emergency departments P. Nourjah, R. A. Bonnel, A. D. Brinker, M. I. Avigan, CDER, FDA, Rockville, MD
I-29 Developmental Neurotoxicity Assessment of Acrylamide in Fischer 344 Rats M. G. Paule, J. Garey, S. A. Ferguson, NCTR, FDA, Jefferson, AR
I-30 What makes public issue communication more effective? - Exploring information format effects W. Qin, J. L. Brown, Department of Food Science, The Pennsylvania State University
I-31 Stability study of ranitidine hydrochloride syrup drug product in bulk and repackaged containers R. B. Shah1 , H. R. Prasanna1 , M. A. Tawakkul1 , B. Rothman2 , M. A. Khan1 , 1DPQR, CDER, FDA, Silver spring, MD, 2OC, FDA, Rockville, MD
I-32 Collective Risk Management for a Sight-threatening Risk from the Expansion of Intraocular Gas Bubble at Various Stages of Perfluoropropane Intraocular Gas Device Life Cycle M. Shih, J. F. Saviola, CDRH, FDA, Rockville, MD
I-PO-33 Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender A. Shoaibi, D. R. Tavris, CDRH, FDA, Rockville, MD
I-34 Seafood-Related Outbreaks, 1990-2003 C. Smith DeWaal, K. Johnson, CSPI
I-35 Salmonella on Produce: Outbreaks from 1990-2003. C. Smith DeWaal, K. Johnson, CSPI
I-36 Guidewire-related Adverse Event Reports in 2005: A Descriptive Analysis R.A. Sullivan, OSB, CDRH, FDA, Rockville MD
I-37 "Take Time to Care": Providing Essential Risk /Benefit Information to Women through FDA Office of Women's Health Outreach K. A. Thomas, S. Perry, FDA OWH, Rockville, MD
I-38 MedDRA Processing of Adverse Event Reports in the Veterans Health Administration Pharmacy Benefits Management Adverse Drug Event Program A. Vega1 , S. Brajovic1 , V. Subramaniam2 , J. Lee1 , M. Vieder1 , B. Bradic1 , 1PSI International, 2VHA Pharmacy Benefits Management SHG
I-39 COMPARATIVE STABILITY OF WHOLE AND SPLIT GABAPENTIN TABLETS A. Gupta1 , A. B. Ciavarella1 , V. A. Sayeed2 , P. J. Faustino1 , D. A. Volpe1 , M. A. Khan1 , 1DPQR, CDER, FDA, Silver Spring, MD, 2OGD, CDER, FDA, Rockville, MD
I-40 Some Results of a Risk-Based Model for Prioritizing Current Good Manufacturing Practice (CGMP) Inspections of Human Pharmaceutical Manufacturing Sites S. B. Wang, B. Hasselbalch, V. Zenger, J. Gardner, CDER, FDA
I-41 Adverse Events Associated with Vacuum-Assisted Delivery Devices B. Wang, D. Marinac-Dabic, G. B. Marjorie, CDRH, FDA, Rockville, MD
I-42 Anaphylactoid Reactions to Dextran 40 and 70: Reports to the US Food and Drug Administration (FDA), 1969-2004 C. E. Zinderman, L. Landow, R. P. Wise, CBER, FDA, Rockville, MD
I-PO-08 Development of a Tolerable Contact Limit (TCL) for ethylene oxide residues on sterilized medical devices R. P. Brown, W. H. Cyr, M. E. Stratmeyer, CDRH, FDA, Silver Spring, MD
I-PO-28 Gender-Differential Drug Risk Evaluation in Adolescents and Young Adults: Examination of Top 30 Drug Prescriptions Data R. Ouellet-Hellstrom, C. Kornegay, R. Johann-Liang, FDA
J-01 Hurricane Response 2005: PHS Commissioned Corps Officers on the Front Lines S. Caviness, FDA, Rockville, MD
J-02 Development of a Transportable System for Radionuclide Analysis W. C. Cunningham1 , D. L. Anderson1 , W. Lamont1 , P. South1 , M. Rury2 , G. Beachley2 , J. Ondov2 , 1CFSAN, FDA, College Park, MD, 2University of Maryland, College Park, MD
J-03 Simultaneous Detection of Abrin, Botulinum Toxin, Ricin, and Staphylococcus Enterotoxin B (SEB) in Beverages Using Luminex Multiplex Technology E. A. Garber1 , K. V. Venkateswaran2 , J. L. Aldrich3 , T. W. O'Brien3 , K. G. Oliver2 , 1CFSAN, FDA, College Park, MD, 2Radix Biosolutions, Georgetown, TX, 3Tetracore Inc., Rockville, MD
J-04 Elimination of Wheat Lectin-based False Positives Associated with Lateral Flow Devices for Detection of Ricin and Staphylococcus Enterotoxin B E. A. Garber1 , J. Dayan-Kenigsberg2 , A. Bertocchi2 , 1CFSAN, FDA, College Park, MD, 2Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France
J-05 Detection Of Abrin In Foods Using ELISA and Electrochemiluminescence (ECL) Technologies E. A. Garber1 , J. L. Aldrich2 , J. Wang2 , V. A. Brewer1 , T. W. O'Brien2 , G. Sigal3 , 1CFSAN, FDA, College Park, 2Tetracore Inc., Rockville, MD, 3Meso Scale Diagnostics, LLC, Gaithersburg, MD
J-06 Effects of Cooking on Detection & Toxicity of the Beans from Abrus Precatorius E.A. Garber, CFSAN, FDA, College Park, MD
J-07 Evaluation of the FDA-FERN Screening Method Developed for the Isolation and Identification of Yersinia pestis from Foods. D. E. Hanes1 , M. H. Kothary1 , B. D. Tall1 , S. G. Edelson-Mammel2 , D. H. Burr3 , S. D. Weagant4 , 1CFSAN, FDA, Laurel, MD, 2CFSAN, College Park, MD, 3CFSAN, Madison, WI, 4ORA, Bothell, WA
J-08 Discrimination of Shigella sub-groups and strains by identification of single nucleotide polymorphisms A. E. Hayford1 , M. K. Mammel1 , J. Worley2 , J. E. LeClerc1 , T. A. Cebula1 , 1OARSA, CFSAN, FDA, Laurel, MD, 2JIFSAN, FDA, Laurel, MD
J-09 US Public Health Service Hurricane Katrina Response - PMAC Pharmacy C. T. Jung1 , V. E. Jensen2 , W. F. Pierce2 , B. Y. Danso1 , K. A. Awuah1 , 1CDER, FDA, Rockville, MD 20855, 2CDER, FDA, Silver Spring, MD 20993
J-10 Recovery of Bacillus anthracis from Various Artificially Contaminated Foods Using Cultural and PCR Methodologies S. M. Madson1 , E. D. Gonzales1 , L. T. Michel1 , Z. A. Miller1 , M. B. Buen1 , D. E. Farmer1 , P. L. Dexter1 , M. Z. Thomas1 , K. A. Watts1 , K. S. Kreuzer1 , C. L. Burns1 , J. N. Sofos2 , 1FDA Denver District Laboratory, Denver, CO 80225, 2Colorado State University, Fort Collins, CO 80523
J-11 Environmental Effects on the Operation of Lateral Flow Devices (LFDs) used in the Detection of Ricin in Foods M.A. McLaughlin, CFSAN, FDA, USPHS, College Park, MD
J-12 Effect of Toxic Chemicals on the Conductivity of Liquid Foods W. R. Mindak, J. Cheng, FDA, College Park, MD
J-13 Distribution coefficients for alpha-Amanitin, Ricin and T-2 toxin in milk and salad dressings H. Njapau1 , F. S. Thomas1 , A. Chowdhury2 , S. Trujillo1 , B. J. Cañas1 , D. L. Park1 , 1CFSAN, FDA, College Park, MD, 2JIFSAN/University of Maryland, College Park, MD
J-14 Effects of Food Preparation and Lactose on the Detection and Lectin Binding Ability of Ricin B-Chain G. M. Orlowski1 , G. C. Ziobro2 , E. A. Garber2 , 1JIFSAN, University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD
J-15 Microarray-Whole Genome Amplification based analysis of bacterial pathogens N. Sergeev1 , A. Rasooly2 , 1FDA/CDRH/OSEL/DB, Silver Spring, MD, 2NIH-National Cancer Institute, Rockville, MD
J-16 Rapid microbial pathogen DNA amplification using a battery-powered thin-film resistive heater thermocycler N. Sergeev1 , A. Matviyenko2 , K. Herold2 , A. Rasooly3 , 1FDA/CDRH/OSEL/DB, Sliver Spring, MD, 2UMD-University of Maryland, College Park, MD, 3NIH-National Cancer Institute, Rockville, MD
J-17 CFSAN Outbreak Surveillance Database: Outbreaks and illnesses reported for 2004 and 2005 K. Vierk1 , E. Elliot1 , J. J. Guzewich1 , G. Henderson1 , T. Hill1 , K. C. Klontz1 , P. McCarthy1 , S. McGarry1 , C. Purdy2 , M. Ross1 , J. Sanders1 , F. K. Shakir1 , D. Street1 , B. Timbo1 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA, Atlanta, GA
J-18 Contributing Factors (CFs) Identified in Produce-Associated Outbreaks from CDC's National Electronic Foodborne Outbreak Reporting System (eFORS), FoodNet Sites, 1999-2002 F. K. Shakir1 , P. V. McCarthy1 , J. J. Guzewich1 , C. R. Braden2 , K. C. Klontz1 , C. W. Hedberg3 , K. E. Fullerton4 , A. Bogard5 , M. Dreyfuss6 , K. Larson7 , D. Vugia8 , D. C. Nichols9 , V. J. Radke2 , T. F. Jones10 , 1FDA, Center for Food Safety and Applied Nutrition, Washington, DC, 2CDC, Atlanta, GA, 3University of Minnesota, Minneapolis, MN, 4CDC, Atlanta, GA, Atlanta Research and Education Foundation, Atlanta, GA, 5Minnesota Department of Health, Minneapolis, MN, 6USDA, Food Safety and Inspection Service, Washington, DC, 7Maryland Department of Health and Mental Hygiene, Baltimore, MD, 8California Emerging Infections Program, Oakland, CA, 9New York State Department of Health, Albany, NY, 10Tennessee Department of Health, Nashville, TN
J-19 Evaluating the use of fatty acid profiles to identify Francisella tularensis P. Whittaker, J. B. Day, S. K. Curtis, F. S. Fry, CFSAN, FDA, College Park, MD
J-PO-20 APPLICATION OF PEDXRF TO RAPID SCREENING OF TOXIC ELEMENTS IN FOODS AND ASIAN PATENT MEDICINES R. M. Jacobs1 , P. T. Palmer2 , 1San Francisco District Lab, ORA, FDA, Alameda, CA, 2San Francisco State University, San Francisco, CA
J-PO-21 Development and Comparison of Enrichment Media for the Isolation of Yersinia pestis from Lettuce. S. D. Torosian1 , P. Regan1 , A. B. Margolin2 , 1FDA, 2University of New Hampshire
K-01 Dermal Sensitization Quantitative Risk Assessment QRA) For Fragrance Ingredients A. M. Api1 , D. A. Basketter2 , P. A. Cadby3 , M. F. Cano4 , G. Ellis5 , G. F. Gerberick6 , P. Griem7 , P. M. McNamee6 , C. A. Ryan6 , R. Safford2 , 1Research Institute for Fragrance Materials, Inc., 2SEAC, Unilever, 3Firmenich, Inc., 4LVMH, 5Givaudan France Fragrances, 6The Procter & Gamble Company, 7Clariant Producke GmbH
K-02 What is FDA doing about indoor tanning? J. Z. Beer, W. H. Cyr, S. G. Coelho, B. Z. Zmudzka, S. A. Miller, CDRH, FDA, Rockville, MD
K-03 Development and Regulation of Nicotine Replacement Therapy Products from Natural Tobacco J. H. Boal, D. D. Christodoulou, R. S. Harapanhalli, cder
K-04 Emerging Delivery Systems of Fentanyl and Their Regulation J. H. Boal, R. S. Harapanhalli, CDER, FDA
K-05 Inter-Center Modeling Consortium I. A. Chang1 , H. M. Luu1 , J. Hutter1 , M. Katzper2 , C. S. Kim3 , 1CDRH,FDA,, Rockville MD, 2CDER, FDA, Silver Spring MD, 3CFSAN, FDA, Laurel MD
K-06 Pharmaceutical Development Report in the Assessment of Pharmaceutical Quality in an NDA D. D. Christodoulou1 , R. S. Harapanhalli2 , 1Review Chemist, ONDQA, CDER, FDA, 2Branch Chief, ONDQA Branch V, CDER, FDA
K-07 Home Use Devices: Using a Public-Private Partnership to Address Gaps in Information S. Gardner, M. Brady, H. Albersheim, S. Berman, J. Cope, M. Eakle, P. Jahnes, P. Jones, R. Lazerow, M. Mendelson, A. Pinkos, E. Skoda, M. Warner, M. A. Wollerton, A. A. Ciarkowski, CDRH Home Health Care Committee
K-08 Measuring Citizen Satisfaction with FDA E-mail Performance Standards K. C. Dada, G. Creath, M. E. Kremzner, R. Chhabra, CDER, FDA, Rockville, MD
K-09 FDAMA Section 113: sponsor compliance with listing trials in ClinicalTrials.gov J. Derbis1 , T. Toigo1 , B. Evelyn2 , 1OC, FDA, Rockville, MD, 2OC, FDA, Rockville MD
K-10 Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims B. M. Derby1 , A. S. Levy2 , 1CFSAN, FDA, College Park, 2CFSAN,FDA,College Park
K-11 INTERNATIONAL HARMONIZATION OF TESTING FOR PHARMACEUTICALS: ANIMAL PROTECTION AT THE ICH S. Dhruvakumar, PETA
K-12 Utilization of antiplatelet therapy with drug-eluting coronary stent implantation H. J. Duggirala1 , S. Gola2 , T. P. Gross1 , A. Boam1 , 1CDRH, FDA, Rockville, MD 20850, 2Case Western Reserve University, Cleveland, OH, 44106
K-13 The President's Emergency Plan for AIDS Relief (PEPFAR) Program: Involvement of the FDA's Office of Generic Drugs B. F. Fritsch, C. T. Jung, B. M. Davit, CDER, FDA, Rockville, MD
K-14 Desktop Disintegration Test for Orally Disintegrating Tablets (ODT's): A Rapid and Simple Method for Observing the Disintegration Behavior for the Regulatory Review Scientists in the Evaluation of Drug Applications F. Fang, R. Adams, H. A. Hahm, CDER, FDA, Rockville, MD
K-15 Heparin and its Fragments: Scientific and Regulatory Challenges A. A. Hakim, R. S. Harapanhalli, CDER, FDA
K-16 Risk Management of Warfarin Overanticoagulation: Role of Pharmacogenomic Information M. J. Kim, S. M. Huang, F. W. Frueh, A. N. Rahman, Y. M. Choi, K. M. Robie Suh, G. Shashaty, R. Rieves, L. J. Lesko, CDER, FDA, Silver Spring, MD
K-17 Drug-Drug, Drug-Dietary Supplement, and Drug-Citrus Fruit and Other Food Interactions- Labeling Implications S. M. Huang1 , R. Temple2 , L. J. Lesko1 , 1Office of Clinical Pharmacology, 2Office of Medical Policy, CDER, FDA, Silver Spring, MD
K-18 In-hospital Mortality Following Hip Replacement: Results of a Nationally Representative Survey C. Zhan1 , R. G. Kaczmarek2 , N. Loyo-Berrios3 , 1AHRQ, Rockville, MD, 2FDA, Rockville, MD, 3FDA, Rockville, Maryland
K-19 Regulatory Framework for Positron Emission Tomography Drugs R. K. Kasliwal1 , E. E. Leutzinger1 , B. W. Uratani2 , 1CDER, FDA, Silver Spring, MD, 2CDER, FDA, Rockville MD
K-20 Systems Biology and the FDA Review Process M. Katzper, S. Sobel, CDER, FDA, Rockville, MD
K-21 Dynamic Responses to Drug Interventions M. Katzper, CDER, FDA, Silver Spring, MD
K-22 Committee for the Advancement of FDA Science (CAFDAS): The FDA Scientist's Liaison to the Commissioner's Office N. Alderson1 , U. S. Babu2 , P. Chu3 , T. Crone4 , C. Elkins5 , R. M. Fahmy3 , J. V. Gobburu6 , J. Johannessen1 , C. Kavanaugh2 , S. Kumar7 , M. Major7 , M. Manjanatha5 , R. A. Bright8 , H. Trinh1 , S. D. Torosian4 , R. S. Uppoor6 , T. Woods8 , 1OC, 2CFSAN, 3CVM, 4ORA, 5NCTR, 6CDER, 7CBER, 8CDRH
K-23 Improved Methods for Determining Compliance with Global Food Contact and Food Additive Requirements through Government Industry Collaboration K. Randolph1 , H. C. Chang1 , E. Waldron1 , P. Turowski1 , K. A. Smeds1 , V. Gilliam1 , A. Shanklin1 , E. Sanchez1 , M. E. LaVecchia1 , A. M. Hollander1 , J. Ziyad1 , A. L. Lipman1 , M. Cheeseman1 , A. Waldo2 , K. Kenny2 , L. Marchant2 , 1FDA, 2Decernis LLC
K-24 Improving Quality of Care in Sickle Cell Disease Patients: Key to Managing an Otherwise Painful Disease N. C. Mezu-Nwaba1 , O. J. Mezu-Ndubuisi2 , K. R. Mezu3 , 1CDRH, FDA, 2LSU, Shreveport, Louisiana, 3Morgan State University, Baltimore, MD
K-25 Comparison of different UV exposure regimens for cosmetic tanning S. A. Miller, B. Z. Zmudzka, S. G. Coelho, J. Z. Beer, CDRH, FDA, Rockville, MD
K-26 Burns in MRI patients wearing transdermal drug delivery systems A. K. Mitra, E. P. Duffy, ONDQA, OPS, CDER, FDA
K-27 A repository of clinical pharmacokinetics data for drugs used in pregnancy and lactation developed at FDA S. C. Nallani1 , L. D. Coles2 , 1OCP, CDER, Silver Spring, MD, 2College of Pharmacy, University of Maryland, Baltimore, MD
K-28 High Field NMR and Characterization of Polysaccharide Vaccines S. E. Norris, D. I. Freedberg, CBER,FDA,Rockville, MD
K-29 The Office of Women's Health: Impact of Research Program D. Obias-Manno, P. Scott, J. Kaczmarczyk, E. Pinnow, K. Uhl, OWH
K-30 Comparison of Ethinyl Estradiol Pharmacokinectics in Combined Hormonal Contraceptives. J. Y. Park1 , M. J. Kim1 , S. Ortiz1 , V. R. Jarugula2 , A. Parekh1 , 1DCPIII, OCP, CDER, FDA, SILVER SPRING, MD, 2DCPIV, OCP, CDER, FDA, SILVER SPRING, MD
K-31 Bioequivalence Issues of Highly Variable Drugs in Generic Drug Applications D. Patel, B. M. Davit, S. H. Haidar, X. Jiang, B. Fabian-Fritsch, L. Yu, D. P. Conner, Office of Generic Drugs, CDER, FDA
K-32 Contraception Requirements for Participation in Clinical Trials E. Pinnow1 , P. Scott1 , J. Derbis2 , T. Toigo2 , K. Uhl1 , 1OWH, 2OSHI
K-33 Using the CFSAN Thesaurus to Improve Scientific Communication II E. A. Reinhold1 , D. M. Schmit1 , L. R. Dusold2 , 1Computer Technology Services, Inc. (CTS), Rockville, MD, 2OIT-CFSAN, FDA, College Park, MD
K-34 CHARACTERISTICS OF DONORS IMPLICATED IN FATAL TRANSFUSION RELATED ACUTE LUNG INJURY (TRALI) REACTIONS L. Holness, M. Knippen, L. Simmons, CBER, FDA, Rockville, MD
K-35 19-YEAR REVIEW OF FATALITIES DUE TO CONTAMINATED BLOOD AND BLOOD COMPONENTS L. Holness, P. Jones, M. Knippen, L. Simmons, M. T. Niu, CBER, FDA, Rockville, MD
K-36 Revised Consumption Factor for Polystyrene S. Elyashiv-Barad, K. A. Smeds, DFCN, OFAS, CFSAN, FDA, College Park, MD
K-37 FDA's MedWatch Program J.A. Spearmon, CDER, FDA, Silver Spring, MD
K-38 FDA's Office of Oncology Drug Products R. Pazdur, K. Weiss, D. Ross, G. Jones, D. Spillman, O. H. Suleiman, CDER, FDA, Silver Spring, MD
K-39 Product development considerations: integrated diagnosis treatment combinations M.E. Van Hoef, Transplant Creations, Amsterdam, The Netherlands
K-40 Food Allergen Advisory Statements on Food Labels: Consumer Preferences versus Effectiveness L. Verrill, C. Choiniere, A. Lando, CFSAN, FDA, College Park, MD
K-41 Scientific Perspectives on Drug Transporters and Their Role in Drug Interactions L. Zhang, J. M. Strong, W. Qiu, L. J. Lesko, S. M. Huang, CDER, FDA, Silver Spring, MD
K-42 Datamining the FACTS Database for Trends in Food Adulteration Due to Filth G. C. Ziobro1 , L. A. D Hoostelaere2 , 1CFSAN, FDA, College Park, MD, 2ORA, Rockville, MD
K-PO-43 Tyrosine Kinase Inhibitors Y. A. Hsieh, X. H. Chen, S. Pope, R. S. Harapanhalli, ONDQA, CDER, FDA, Silver Spring, MD 20993
K-PO-44 Regulatory Perspectives of Type II Prodrug Development: Preclinical Pharm/Tox Analysis and the Role of Comparative Toxicology. K. M. Wu, J. G. Farrelly, DAVP/ODEIV/OND/CDER/FDA
L-01 Calibration Standards Needed for Standardization of Clinical Multicolor Flow Cytometry: F. Abbasi1 , V. Zenger2 , L. Wang3 , A. Giagalas3 , R. Vogt4 , G. E. Marti1 , 1CBER, FDA, Rockville, MD, 2CDER, FDA, Rockville, MD, 3NIST, Gaithersburg, MD, 4CDC, Atlanta, GA
L-02 COMPARATIVE STABILITY STUDY OF REPACKAGED FUROSEMIDE TABLETS. E. B. Asafu-Adjaye, A. S. Carlin, E. H. Jefferson, A. R. Bryant, P. J. Faustino, B. Rothman, CDER, FDA, Silver Spring, MD
L-03 Measles Neutralizing Antibodies in Intravenous Immunoglobulins S. Audet, M. L. Virata-Theimer, J. Beeler, D. E. Scott, D. J. Frazier, M. G. Mikolajczyk, N. Eller, F. M. Chen, M. W. Yu, CBER, FDA, Rockville, MD
L-04 Heat Penetration Parameters: A Comparative Study between "Remote" Temperature Sensors and T-Type Thermocouples A. Khurana, G. Awuah, L. Weddig, C. Balestrini, Food Products Assocation, Washington, DC
L-05 BONE DENSITY AFFECTS RELATIONSHIP BETWEEN CEMENT DOSE AND MECHANICAL STRENGTH AFTER VERTEBROPLASTY J. Graham1 , N. Hai2 , B. D. Buch3 , 1OSEL, FDA, Rockville, MD, 2George Washington University, Washington, DC, 3CDRH, FDA, Rockville, MD
L-06 Testing the immunity of medical devices to continuous wave magnetic fields by immersion method V. Buzduga, D. Witters, J. Casamento, P. Ruggera, W. Kainz, S. Seidman, G. Mendoza, CDRH, FDA, Rockville, MD
L-07 Development of In Vitro Peel Adhesion Testing for Transdermal Drug Delivery System B. Cai1 , F. McMaster2 , J. McDonough2 , N. Sadrieh3 , S. Brown4 , A. M. Wokovich5 , W. H. Doub5 , L. F. Buhse5 , P. Schwartz1 , R. Patel1 , M. L. Chen3 , 1OGD, OPS, CDER, FDA, Rockville, MD, 2SouthWest Research Institute, San Antonio, TX, 3OPS, CDER, FDA, Silver Spring, MD, 4CDRH, FDA, Rockville, MD, 5OTR, OPS, CDER, FDA, St Louis, MO
L-08 Premarket Testing Issues with General Use Intravascular Catheters and Accessories with Indications For Use with Power Injection of Contrast Media for Radiographic Studies S. A. Colburn, G. G. Gantt, M. D. Brooks, J. F. Lipman, FDA/CDRH/ODE, Rockville, MD
L-09 Critical Path Initiative: Comparisons between Simulated Night Driving Performance and Clinical Tests of Visual Acuity, Glare, and Contrast Sensitivity E. Rorer, D. Calogero, B. Drum, CDRH, FDA, Rockville, MD
L-10 Evaluation of VIDAS® Immuno-Concentration Salmonella (ICS) and VIDAS® Salmonella Immunoassay (SLM) for rapid detection of Salmonella spp. in selected foods R. Zapata, C. N. Wendakoon, C. Carrillo, P. Browning, W. M. Fedio, Food Safety Laboratory, New Mexico State University
L-11 Detection of Shigella spp. by selective plating and PCR after aerobic enrichment in Shigella Broth C. N. Wendakoon, R. Zapata, W. M. Fedio, Food Safety Laboratory, New Mexico Mexico State University
L-12 Comparison of the Petrifilm Staph Express Count System with the BAM Direct Plate Count Method for enumeration of Staphylococcus aureus in artificially contaminated hard cheese W. M. Fedio, C. N. Wendakoon, R. Zapata, C. Carrillo, P. Browning, Food Safety Laboratory, New Mexico Mexico State University
L-13 Comparison of Antimicrobial Susceptibility Testing Methods for Salmonella enterica serotype Heidelberg Isolates S. L. Foley1 , V. Call2 , P. R. Kaldhone3 , C. D. Tyler3 , L. Potter2 , G. Anderson2 , S. Phillips2 , K. Kerdahi2 , R. Nayak4 , 1Marshfield Clinic Res. Fndn.; Univ. of Central Arkansas and Arkansas Regional Laboratory, ORA, 2Arkansas Regional Laboratory, ORA, 3Marshfield Clinic Res. Fndn. and Univ. of Central Arkansas, 4Division of Microbiology, NCTR
L-14 Comparison of Three Techniques for the Post-Immunomagnetic Separation Detection of Cryptosporidium parvum in Foods and Beverages C. D. Frazar, P. A. Orlandi, CFSAN
L-15 Effect of heat treatment on the quantitative detection of egg proteins using commercial ELISA kits T. J. Fu1 , N. Maks2 , 1CFSAN/NCFST, FDA, Summit-Argo, IL, 60501, 2NCFST, Illinois Institute of Technology, Summit-Argo, IL, 60501
L-16 Evaluation of An Automated Immunomagnetic Separation System for Selective Isolation of E. coli O157:H7, Salmonella and L. monocytogenes from Inoculated Spent Sprout Irrigation Water T. J. Fu1 , N. Maks2 , B. Parisi2 , P. Slade2 , 1CFSAN/NCFST, FDA, Summit-Argo, IL 60501, 2NCFST, Illinois Institute of Technology, Summit-Argo, IL 60501
L-17 Integrating Tangential Flow Filtration with Rapid Tests for Detection of E. coli O157:H7, Salmonella and L. monocytogenes in Large Volumes of Spent Sprout Irrigation Water T. J. Fu1 , K. Reineke1 , T. Krupinski2 , O. VanPelt2 , N. Maks-Warren2 , B. Parisi2 , P. Slade2 , 1CFSAN/NCFST, FDA, Summit-Argo, IL 60501, 2NCFST, Illinois Institute of Technology, Summit-Argo, IL 60501
L-18 Effects of extraction methods in quantitative determination of glutens in food using commercial test kits T. Geng, J. M. Yeung, Food Products Association
L-19 A procedure for acoustic power calibration of high intensity focused ultrasound transducers using a radiation force technique S. Maruvada1 , G. R. Harris1 , B. A. Herman1 , R. L. King2 , 1CDRH, FDA, Rockville, MD, 2King Acoustic Technologies, LLC, Washington DC
L-20 Tissue mimicking materials for high intensity focused ultrasound surgery Y. Liu1 , B. A. Herman2 , R. L. King2 , S. Maruvada2 , G. R. Harris2 , 1Duke University, Durham, NC, 2CDRH, FDA, Rockville, MD
L-21 Confocal fiber-optic laser method for intraocular lens power testing: A novel and simple approach for precise testing of clinical intraocular lens samples I. K. Ilev, R. W. Faaland, R. J. Landry, D. Calogero, CDRH, FDA, Rockville, MD
L-22 Towards the establishment of a valid quantitative molecular biology based pre-clinical safety test for mumps virus. C. J. Sauder, C. Wolbert, S. Rubin, K. M. Carbone, T. Malik, CBER, FDA, Rockville, MD
L-23 Studies on Cell Substrate Safety: Development of in vivo Assays to Assess the Oncogenic Activity of DNA L. Sheng1 , B. Orrison1 , F. Cai1 , Y. Zhu1 , H. Murata1 , A. Pal1 , M. Athanasiou2 , D. Blair2 , S. Hughes2 , J. Coffin2 , A. Lewis1 , K. Peden1 , 1CBER, FDA, Bethesda, MD, 2NCI-FCRF, Frederick, MD
L-24 Non-invasive Estimation of Sunscreen Efficacy by Diffuse Reflectance Spectroscopy A. Agrawal, S. A. Miller, S. Matchette, J. Pfefer, CDRH, FDA, Rockville, MD
L-25 In-Vitro Simulation of Adinazolam Mesylate Swellable HPMC Matrix Release using DDDPlus Software A. Prabhakaran, J. DiBella, W. S. Woltosz, M. B. Bolger, Simulations Plus, Inc., Lancaster, CA
L-26 Evaluation of the Potential for Using a Green Fluorescent protein (GFP) Positive Strain of Salmonella to Replace the Designated Positive Culture Control in Routine Sample Analysis C. Ramirez1 , S. M. Madson1 , T. B. Bickell1 , M. B. Buen1 , C. L. Burns1 , J. S. Cholensky1 , P. L. Dexter1 , D. E. Farmer1 , R. L. Farmer1 , E. D. Gonzales1 , M. A. Jackson1 , K. D. Kallander1 , C. R. Kiessling1 , W. M. Kiessling1 , J. A. Kinney1 , E. W. Laster1 , C. M. Lemons1 , M. H. Loftis1 , M. E. Maselli1 , L. T. Michel1 , Z. A. Miller1 , T. L. Morales1 , C. I. Shaw1 , P. D. Stahnke1 , M. Z. Thomas1 , K. A. Watts1 , J. N. Sofos2 , 1FDA, Denver, CO 80225, 2Department of Animal Sciences, Colorado State University, Ft. Collins, CO 80523
L-27 Detection of Type A, B, E and F Clostridium botulinum Neurotoxins In Foods Using Electrochemilumninescent Immunoassay. S. K. Sharma, R. C. Whiting, CFSAN, Collage Park, MD 20740
L-28 Single Laboratory Validation of Commercially available kits for the detection of Aflatoxin M1 S. Trujillo1 , N. J. Fico2 , H. Njapau1 , B. J. Cañas1 , D. L. Park1 , 1CFSAN, FDA, College Park, MD, 2JIFSAN, University of Maryland, 0220 Symons Hall, College Park, MD 20742
L-29 Ensuring Product Safety by Monitoring Anti-A and Anti-B Levels in US-Licensed Intravenous Immunoglobulin Products M. L. Virata-Theimer1 , S. J. Thorpe2 , M. W. Yu1 , 1CBER, FDA, Rockville, MD, 2NIBSC, Herts, UK
L-30 MRI Safety of Medical Devices: Standard Test Methods and Terminology T.O. Woods, CDRH, Rockville, MD
L-31 Comparative stability of repackaged metoprolol tablets Y. S. Yang, A. S. Carlin, P. J. Faustino, R. C. Lyon, C. D. Ellison, M. L. Hamad, A. R. Bryant, E. H. Jefferson, M. A. Khan, DPQR, CDER, FDA, Silver Spring, MD
L-44 Development of a FACS based potency assay for immuno-modulatory therapeutics using phospho-specific antibodies L. Graham, C. Serrano, I. Reischl, K. DeBell, E. Bonvini, B. Rellahan, Division of Monoclonal Antibodies, OBP, OPS, CDER
L-PO-32 Effect of chiro-inositol and myo-inositol on the delay of cataractogenesis in vitro W. K. Lee1 , H. Kim1 , K. Y. Song2 , K. H. Seo3 , 1SNU, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-33 Study on the extra- and intra-beta-galactosidase activity of probiotic lactic acid bacteria treated by antibiotic and sonication using by high performance liquid chromatography K. Y. Song1 , Y. C. Yoon2 , D. K. Jeong3 , K. H. Seo4 , 1JIFSAN, UMD, College Park, MD, 2Konkuk University, Seoul, South Korea, 3Kosin University, Busan, South Korea, 4CFSAN, FDA, College Park, MD
L-PO-34 Study on yoghurt manufactured from various concentrated raw milk using by ultrafiltration and its changes in quality during storage S. O. Choi1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, FDA, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-35 Study on evaluation for the quality and shelf life on Tofu made from soy milk added WPC and WP J. U. Kim1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-36 Study on the quality of yoghurt made from soy milk added skim milk and whey powder during storage S. M. Shin1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-37 Study on the separation of glycomacropeptide and beta-lactoglobulin from Mozzarella cheese whey, and its seasonal composition changes C. H. Song1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA. College Park, MD
L-PO-38 Study on the separation of glycomacropeptide and beta-lactoglobulin from Cheddar cheese whey S. H. Yoo1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-39 Study on the production and quality of Mozzarella cheese analogue made from the various mixture ratio of soy milk and raw milk during storage J. H. Lee1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-40 Study on the quality of Mozzarella cheese analogue made from the mixture of soy milk and various concentrated raw milk using by ultrafiltration during storage S. H. Lee1 , Y. C. Yoon1 , K. Y. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-41 Study on the quality of Mozzarella cheese analogue made from soy milk added WP, WPC 34, WPC 80, DWP, and LP during storage W. S. Jin1 , Y. C. Yoon1 , R. L. Song2 , K. H. Seo3 , 1Konkuk University, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
L-PO-42 Study on the investigation of the effect by various different factors - fat, bacterial count, rennet, and starter - on producing Mozzarella cheese using by ultrafiltration K. Y. Song1 , Y. C. Yoon2 , S. S. Yoon3 , K. H. Seo4 , 1JIFSAN, FDA, College Park, MD, 2Konkuk University, Seoul, South Korea, 3IFBB, Yonsei University, Seoul, South Korea, 4CFSAN, FDA, College Park, MD
L-PO-43 Protective effect of soy bean extractive pinitol on xylose induced sugar cataract in rates Y. A. Kim1 , H. Kim1 , K. Y. Song2 , K. H. Seo3 , 1SNU, Seoul, South Korea, 2JIFSAN, UMD, College Park, MD, 3CFSAN, FDA, College Park, MD
M-01 The specific anthropomorphic mannequin (SAM) compared to 14 anatomical head models using a novel definition for the mobile phone positioning W. Kainz1 , A. Christ2 , T. Kellom1 , S. Seidman1 , N. Nikoloski2 , B. Beard1 , N. Kuster2 , 1CDRH, FDA, Rockville, MD, 2IT'IS - The Foundation for Research on Information Technologies in Society, Zeughausstrasse 43, 8004 Zurich, Switzerland
M-02 The future of anatomical models - Anatomical CAD models for numerical dosimetry and implant evaluations W. Kainz1 , S. Seidman1 , R. Qiang2 , J. Chen2 , 1CDRH, FDA, Rockville, MD, 2The University of Houston
M-03 Potential Improvement of Computerized Mass Detection on Mammograms using a Bilateral Pairing Technique S. Paquerault1 , N. Petrick1 , B. Sahiner2 , K. J. Myers1 , H. Chan2 , 1CDRH, FDA, Rockville, MD, 2University of Michigan, Ann Arbor, MI
M-04 Evaluation of A Novel Reflectance-Based System For Optical Property Measurement J. Pfefer, A. Agrawal, S. Matchette, CDRH, FDA, Rockville, MD
M-05 Stability of Nano-Scale Constructs in Medical Device Applications C. S. Kim, D. M. Saylor, B. J. Dair, CDRH, Rockville, MD 20852
M-06 Distributed and Grid Computing Software Technologies for Simulation of Human Physiology Y.G. Tirat-Gefen, DESE-OSEL-CDRH-FDA
M-07 Mechanical performance of generic and proprietary enema bottles D. L. Walsh, R. J. Schroeder, S. F. Stewart, CDRH, FDA, Rockville, MD
M-08 Alignment of full and partial CT thoracic scans using bony structures M. A. Gavrielides, N. Petrick, K. J. Myers, NIBIB/CDRH Laboratory for the Assessment of Medical Imaging Systems, Division of Imaging and Applied Mathematics, Office of Science and Engineering laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20852
N-01 Noninvasive Magnetic Resonance Imaging (MRI) of Cellular Trafficking in Immunodeficient Mice with Charge Neutral Gadolinium Complex M. K. Dewanjee1 , M. Lizak2 , S. R. Husain1 , R. K. Puri1 , 1FDA, Bethesda, MD, 2NINDS, Bethesda, MD
N-02 Testing alginate capsules for endotoxin stimulated inflammation D. B. Lyle, J. C. Shallcross, J. C. Breger, V. M. Hitchins, J. J. Langone, CDRH, FDA, Silver Spring, MD 20903
N-03 Glucose Sensing in Psammomys Obesus (Fat Sand Rat) and Possible Method for Converting Islets into the Diabetic State C. L. Zimliki1 , D. Mears2 , V. M. Chenault1 , 1CDRH, FDA, Rockville, MD, 2ICBM, University of Chile, Santiago, Chile
O-01 FDA's Center for Food Safety and Applied Nutrition and the Mushroom Council Collaborate to Optimize the Natural Vitamin D Content of Edible Mushrooms and to Examine their Health Benefits in Different Rodent Models of Innate Immunity. M. Calvo1 , L. H. Garthoff1 , R. B. Raybourne1 , U. S. Babu1 , C. Kelly2 , S. Lodder2 , M. J. Feeney2 , B. Minor2 , D. Beyer3 , R. Beelman3 , J. Pecchia3 , K. Paley3 , N. Chikthimmah3 , P. Mattila4 , 1CFSAN, Laurel, MD 20708, 2Mushroom Council, Dublin, CA 94568, 3The Mushroom Research Center, Penn State University, University Park, PA 16802, 4MTT Agrifood Research, Finland
O-02 Duration of use for the amphetamine congeners A.G. Feight, CDER, FDA, Silver Spring, MD
O-03 Antioxidant properties and phytochemical contents of cold-pressed onion, parsley, cardamom, mullein, roasted pumpkin, and milk thistle seed oils. J. W. Parry, L. Su, K. Zhou, L. Yu, University of Maryland, College Park
P-01 Color Additive Regulation: A History J. N. Barrows1 , B. R. Meyers1 , N. Richfield-Fratz1 , C. J. Bailey1 , A. L. Lipman2 , 1Office of Cosmetics and Colors, CFSAN, FDA, College Park, MD, 2Office of Food Additive Safety, CFSAN, FDA, College Park, MD
P-02 Combating Health Fraud: Then and Now G. Coody, D. Vasbinder, ORA, Rockville, MD
P-03 History of FDA's Policy on Foods and Feeds Derived from Biotechnology M. D. Ditto, S. Choudhuri, CFSAN, FDA, College Park, MD
P-04 FDA's Approach to the GRAS Provision: A History of Processes P. M. Gaynor, R. Bonnette, E. Garcia, L. S. Kahl, L. G. Valerio, Jr., CFSAN, FDA, College Park, MD
P-05 Developments in Cosmetics Regulation: A Historical Overview B. R. Meyers, J. N. Barrows, Office of Cosmetics and Colors, CFSAN, FDA, College Park, MD
P-06 USP and FDA: A Century of Collaboration A. G. Long, J. R. Payette, United States Pharmacopeia
P-07 Compendial Science and FDA: Promoting Public Health T. L. Cecil, S. Schuber, United States Pharmacopeia
P-08 History of Infant Formula Regulation in the U.S. 1906 - 2006 S. A. Anderson, L. T. Beker, E. S. Cho, G. L. Robert-Baldo, B. M. Silverman, S. K. Suggs-Anderson, L. H. Tonucci, ONPLDS, CFSAN, FDA
P-09 History of the Internet at CFSAN L. R. Dusold1 , F. S. Fry2 , M. O. Walderhaug2 , D. M. Schmit3 , E. A. Reinhold3 , M. E. Chen1 , 1OIT-CFSAN, FDA, 2CFSAN, FDA, 3Computer Technology Services, Inc. (CTS), Rockville, MD
P-10 History of Computing at CFSAN G. A. Brindza1 , R. L. Byle1 , L. R. Dusold1 , C. E. Exley2 , D. M. Schmit3 , S. G. Yin4 , 1OIT-CFSAN, FDA, 2OIT-CFSAN, FDA, Retired, 3Computer Technology Services, Inc. (CTS), Rockville, MD, 4OITSS, FDA
P-11 History of FDA's Voluntary Cosmetics Registration Program M. V. Waleski1 , L. K. Parker2 , D. C. Havery2 , 1OFFICE OF COSMETICS AND COLORS, 2COSMETICS AND COLORS
P-12 B. J. Howard, More Then Mold Counts G.C. Ziobro, CFSAN, FDA, College Park, MD
P-13 Bureau of Chemistry, Microchemical Laboratory: 102 Years of Research G.C. Ziobro, CFSAN, FDA, College Park, MD
P-14 Health Sciences Luminaries Poster Series Project L. Robinson, Howard University
A-36
B-26