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FDA Science, A Century of FDA Science: Pioneering The Future of Public Health, 12th Annual FDA Science Forum, April 18-20, 2006
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A. ANALYTICAL CHEMISTRY: METHODS DEVELOPMENT AND APPLICATIONS

A-01
Surface Plasmon Resonance Biosensor Analysis for Chloramphenicol Residue Determination in Crab and Shrimp.
W.C. Andersen

A-02
Compton Suppression Spectrometry for Analysis of Short-lived Neutron Activation Products in Foods.
D.L. Anderson

A-03
Characterizing perfluorochemical migration from food contact paper.
T.H. Begley

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. Yang

A-05
Overcoming the Bottleneck of Sample Preparation using Tablet Processing Workstation.
Y.T. Cain

A-06
Ion Mobility Spectrometry – Successful Implementations and The Path Forward.
Y.T. Cain

A-07
Rapid Packaging ID of Pharmaceutical Drug Product using Fiber Optic Probe Fluorescence Spectroscopy.
Y.T. Cain

A-08
Fiber Optic Dissolution: The Future.
Y.T. Cain

A-09
Analysis of erythromycin residues in salmon by LC-MS-MS.
M.C. Carson

A-10
Determination of Total Bound and Free Residues of Nitrofurans in Milk of Lactating Cows Using Liquid Chromatography/Tandem Mass Spectrometry.
P. Chu

A-11
Determination of Trace Amounts of Penicillin in Cephalosporins by Liquid Chromatography.
D. Dai

A-12
Development of a SPME-GC-MS Method for the Determination of Coumarin in Vanilla Extract.
L.S. de Jager

A-13
A novel method of measuring mass loss from bioresorbable polymers containing optically-active compounds.
M.W. Diamond

A-14
Seafood Biotoxin Risk Management Success Story: 2005 New England Paralytic Shellfish Poisoning (Non)-Event.
S.M. Etheridge

A-15
Size exclusion chromatography (SEC) with refractive index detection to assess the molecular weight (MW) of polysaccharides.
P.J. Faustino

A-16
Detection and Structural Characterization of Phosphodiesterase-5 Inhibitor Analogs in Suspect Counterfeit Products and Dietary Supplements.
C.L. Flurer

A-17
Studies of Variability in Dissolution Testing with USP Apparatus 2.
Z. Gao

A-18
Generic Drug Products Demonstrate Small Differences in Bioavailability Relative to the Brand Name Counterparts: A Review of ANDAs Approved 1996 - 2005.
S.H. Haidar

A-19
Dioxins and Furans Found in Olive Oil.
M.K. Halbert

A-20
Production and purification of marine biotoxins to support FDA research and regulatory programs.
S. Hall

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. Hayward

A-22
Method for determining fat in freeze-dried cow’s milk during an automated extraction and purification procedure for halogenated organic pollutants.
D.G. Hayward

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

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

A-25
Determination of Retinol, Retinyl Palmitate and Retinoic Acid in Consumer Cosmetic Products.
J.C. Hubinger

A-26
Comparison of Escherichia O157:H7 isolates using a multilocus variable-number tandem repeat analysis (MLVA).
J. Jean-Gilles

A-27
A Quick Method for Identification of Certifiable Color Additives By FTIR.
A.N. Joshi

A-28
NMR – An alternative method to Measure pKa.
P.A. Jupp

A-29
Sensitive Liquid Chromatography/Tandem Mass Spectrometry Method for the Quantitation and Confirmation of Oxytocin in a Dilute IV Saline Solution.
C.M. Karbiwnyk

A-30
Establishment of ELISA for Quantification of Human Alpha-1-Proteinase Inhibitor.
E. Karnaukhova

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

A-32
Interaction of Human Serum Albumin with Retinoids.
E. Karnaukhova

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

A-34
Development of an LC/MS quantitative method for sulfadimethoxine residue and major metabolite in bovine tissues and fluids.
H. Li

A-35
Simultaneous Quantitative Analysis of Histamine, Putrescine and Cadaverine of Scombroid Fish Samples and Fishery Products by Cationic Ion Chromatography.
B.S. Liao

A-36
Determination of Nitrofuran Residues in Honey.
M.I. Lopez

A-37
Thermogravimetric Methods: Applications to Determination of Residual Moisture in Freeze-Dried Biological Products.
J.C. May

A-38
Rapid Determination and Confirmation of Four Fluoroquinolone Residues in Fish Tissue.
S.E. McMullen

A-39
Novel Fluorometric Assay for Hydroxyl Radical Scavenging Capacity (HOSC) Estimation.
J. Moore

A-41
Assessment of Tests Marketed for Detection Ruminant Proteins in Finished Feed.
M.J. Myers

A-42
Determination of MS-222 residues in farmed fish.
C.B. Nochetto

A-43
Screening and Confirmatory Methods for the Detection of Monofluoroacetic Acid in Foods by Liquid Chromatography Mass Spectrometry.
G.O. Noonan

A-44
Determination of HKI-272 in Human Plasma by LC/MS/MS.
M.A. Osman

A-45
Determination of PSI-697 in Human Plasma by LC/MS/MS.
M.A. Osman

A-46
Stability-Indicating Method for Glycopyrrolate in Compounded Glycoprrolate Oral Suspension Formulae.
J.R. Payette

A-47
Method Development and Validation of an HPLC Assay Method for the Quantitation of Trimethoprim in Compounded Oral Preparations.
J.R. Payette

A-48
Method Development and Validation of an HPLC Assay Method for the Quantitation of Flecainide in Compounded Preparations of Flecainide Oral Suspensions.
J.R. Payette

A-49
Evaluation of Ginger Capsules by Dissolution Profile and Content of Marker Compounds.
J.R. Payette

A-50
Experimental Design for Dissolution Variance Study of USP Prednisone Tablets.
J.R. Payette

A-51
Chemical and Physical Characteristics of USP Prednisone Tablets Lot P.
J.R. Payette

A-52
USP Apparatus 4 Dissolution Profile of Prednisone Tablets Lot P.
J.R. Payette

A-53
Gas Chromatographic Analysis of Sugars and Sugar Alcohols in Foods of Low Carbohydrate Content.
J.L. Perry

A-54
Direct Method for the Determination of Sudan I in FD&C Yellow No. 6 by Reversed-Phase High Performance Liquid Chromatography.
B. Petigara

A-55
Direct Method for the Determination of Sudan I in D&C Orange No. 4 by Reversed-Phase High Performance Liquid Chromatography.
B. Petigara

A-56
Immuno-Affinity Centrifugal Precipitation Chromatography: Pilot Studies.
L. Qi

A-57
Use of HPLC analysis of ginsenoside content to develop a cost comparison among ten commercially available ginseng products.
J.I. Rader

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

A-59
Development and Validation of a Microarray-Based Assay that Rapidly Detects Genetic Variability in West Nile Virus Genome.
M. Rios

A-60
Determination of usnic acid in toxic lichen by liquid chromatography with ultraviolet and tandem mass spectrometry detection.
J.A. Roach

A-61
Determination of Avermectin Residues in Raw Milk, Pasteurized Whole Milk and Pasteurized Skim Milk using HPLC with Fluorescence Detection.
W. Rowe

A-62
Development of Official Analytical Methods and Reference Materials for Dietary Supplements.
L.G. Saldanha

A-63
Forensic Chemistry Center: Solutions to Current Forensic Challenges Using Multiple Analytical Approaches.
R. Satzger

A-64
Determination of Chlorothalonil Pesticide Residues in Produce Samples: Analytical Difficulties.
F.J. Schenck

A-65
Isotopic Labeling Method for Quantitation of Peanut Allergens using Mass Spectrometry.
K. Shefcheck

A-66
Intact Protein Biomarker Discovery for Determining Animal Host of Salmonella enterica serovar Newport.
R. Singh

A-67
Analysis of Aminoglycosides in Animal Feed by LC/MS.
M.L. Smith

A-68
LC-MS Analysis of Star Anise, Black Cohosh and Grape Seed Extract.
R.E. Smith

A-69
Analysis of dietary supplements containing Blue Cohosh (Caulophylum thalictroides) for major alkaloids and saponins by high performance liquid chromatography (HPLC).
S. Subramaniam

A-70
Use of LC/MS and NMR to identify selected diterpenoids in methanol extracts of authenticated Teucrium chamaedrys L. and T.canadense (Germander).
R. Sundaresan

A-71
Characterization of CMD-193, a Calicheamicin-Anti-Lewis Y Monoclonal Antibody Conjugate Using LC-MS and LC-MS/MS.
J.X. Tang

A-72
LC-APPI-MS of Steroids and Small Organic Molecules Using PhotoSprayTM Ion Source.
J.X. Tang

A-73
Improved Method of Analysis for Histamine in Canned Fish without Derivatization.
S. Tefera

A-74
Determination of Aflatoxins in Ginseng Herbal Supplements.
M.W. Trucksess

A-75
Determination of Fumonisin B1 in Botanical Roots.
M.W. Trucksess

A-76
Development of a multi-class multi-residue LC-MS screening method for drugs residues in milk.
S. Turnipseed

A-77
Sulfite Determination in Dried Fruits: A Comparison of the Monier-Williams Procedure and Anion Exchange Chromatography.
J.R. Urban

A-78
In Vitro gastric and intestianl stability of Venlafaxine.
D.A. Volpe

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.G. Vostal

A-80
Analysis for Formaldehyde in influenza virus vaccines by an HPLC method.
H. Wang

A-81
Unravel the Mystery of NONMEM Estimation Methods by Visualization.
Y. Wang

A-82
Investigation of Flour Tortillas Implicated in Episodes of Illnesses Associated with School Lunches.
C. Warner

A-83
Antimicrobial Resistance and Genetic Relatedness among Salmonella from Retail Foods of Animal Origin: NARMS Retail Meat Surveillance.
D.G. White

A-84
Differentiation of Enterobacter sakazakii from closely related Enterobacter and Citrobacter species using fatty acid profiles.
P. Whittaker

A-85
Quality by Design in Analytical Chemistry.
L.J. Wrisley

A-86
Gas chromatography/mass spectrometry determination of carbon monoxide in commercially treated tuna and mahi-mahi.
W. Wu

A-87
Effects of Conjugated Linoleic Acid (CLA) Isomers on Oxygen Diffusion-Concentration Products in Liposomes and Phospholipid Solutions.
J. Yin

A-88
Accurate Identification of Trans Fatty Acid Methyl Ester Peaks Using GC-FID on a Polar Capillary Column.
S. Yoo

A-91
Development of an LC-UV Method for the Determination of Coumarin in Vanilla Extract.
L.H. Ali

A-PO-89
Simulated field application of PEDXRF for the detection of acute levels of some toxic elements in two model foods.
R.M. Jacobs

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.
R.M. Jacobs


TOP

B. BIOLOGICAL ENDPOINTS: MICROBIOLOGY, VIROLOGY, ALLERGENICITY, BIOCHEMISTRY, TOXICOLOGY

B-01
Alterations in Blood-Brain barrier function by morphine and methamphetamine.
S.F. Ali

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-Khaldi

B-03
Evaluation of Commercially Available ELISA-Based Kits for Protein Fining Agents in Wine.
J.R. Ammann

B-04
Differential reactive oxygen and nitrogen production and clearance of Salmonella serovars by chicken and mouse macrophages.
U.S. Babu

B-05
An Improved Automated Enzyme Linked Immunosorbent Assay Based Method for Detection of Staphylococcal Enterotoxin by Antibody Modification.
R.W. Bennett

B-06
Aminoglycoside Resistance Genes Found in Enterococcus spp. Recovered From Retail Meats.
S.M. Bodeis-Jones

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-Cahen

B-08
Intravenously administered ethylene glycol (EG) produces hemolysis and hemodynamic changes in the pig.
R. Brown

B-09
Cytotoxicity of extracts from ethylene oxide-sterilized cardiopulmonary bypass oxygenators.
R. Brown

B-10
Cell line sensitivity to a cleaning agent and disinfectant used to reprocess single-use medical devices.
R. Brown

B-100
Characterization of Antimicrobial Resistance of Salmonella Isolates Recovered From Diseased Animals.
S. Zhao

B-11
Qualitative Analysis of Streptococcus Group A Rapid Antigen Detection Test Kit.
G.S. Bushar

B-12
The PE_PGRS33 protein of Mycobacterium tuberculosis induces an immune response that may benefit the pathogen.
N. Cadieux

B-13
Bazedoxifene acetate in vitro metabolism.
A. Chandrasekaran

B-14
Multi-virulence-locus sequence typing identifies epidemic clones from numerous listeriosis outbreaks.
Y. Chen

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. Chenault

B-16
Reduced fitness of individual parts of vaccine poliovirus genomes may determine the pattern of their recombination in vivo.
E. Cherkasova

B-17
Characterization of Campylobacter recovered from NARMS Retail Meats by Pulsed-Field Gel Electrophoresis.
P. Cullen

B-18
Evaluation of inactivation methods for severe acute respiratory syndrome coronavirus (SARS-CoV) in non-cellular blood products.
M. Darnell

B-19
Exploring the programmed cell death pathways of human parasites to identify novel drug targets.
A. Debrabant

B-20
Rational Vaccine Design: Rendering Black-Box Animal Potency Testing Obselete.
S. Dhruvakumar

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-Mammel

B-22
Inactivation of Escherichia coli O157:H7, Salmonella spp. and Listeria monocytogenes in Cranberry Juice Concentrates.
E. Enache

B-23
Characterization of a Rodent Pediatric Nephrotoxicity Model.
P. Espandiari

B-24
Anthrax Lethal Toxin Has Direct and Potent Inhibitory Effects on B Cell Proliferation and Immunoglobulin Production.
H. Fang

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. Fields

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

B-27
Endonuclease G is an important cell death nuclease in trypanosotmatid parasites.
S. Gannavaram

B-28
Impact of Seven Day Storage on Immunophenotypes and Activities of Cell Membrane Microparticles in Apheresis Platelets.
M.P. Gelderman-Fuhrmann

B-29
Role of double stranded RNA (dsRNA) in apoptosis induction by hepatitis A virus.
B.B. Goswami

B-30
Detection of Escherichia coli O157:H7 in Produce.
M.A. Grant

B-31
Mechanism of escape from HIV peptide fusion.
N. Gupta

B-32
Effectiveness of the Bacteriological Analytical Manual Salmonella Culture Method for the Recovery of Salmonella Typhi from Selected Foods.
T. Hammack

B-33
Comparison of Salmonella enterica serotype Newport isolates from 1958-2003 using Multi-Locus Sequence Typing and Antimicrobial Susceptibility Profiling.
H.C. Harbottle

B-34
Real Time PCR Detection of 16S rRNA Genes Speeds MPN Enumeration of Foodborne Listeria monocytogenes.
A.D. Hitchins

B-35
Proteomic Analysis of Lymph Nodes in Female SKH-1 Hairless Mice Following Tattooing.
P.C. Howard

B-36
Gene Expression Profiles in Tattooed Skin of SKH-1 Hairless Mice.
P.C. Howard

B-37
Quantification of Nanoscale Quantum Dot Fluorescence in Tissues.
P.C. Howard

B-38
Penetration of Nanoscale Quantum Dots in Dermabraded Mouse Skin.
P.C. Howard

B-39
Comparison of five methods of sample preparation for the isolation of Salmonella from alfalfa seeds.
A. Jacobson

B-40
Pulsed Field Gel Electrophoresis of Enterobacter sakazakii Strains Reveals Extensive Genotypic Diversity.
C.E. Keys

B-41
Single Enzyme Pulsed-Field Gel Electrophoresis is a Poor Evolutionary Indicator in Salmonella.
C.E. Keys

B-42
Antimicrobial Resistance Patterns of Salmonella Isolated from FDA Regulated Products During 2005.
C.R. Kiessling

B-43
Involvement of Interleukin-13 Receptor in Development of Glioblastoma Multiforme.
M. Kioi

B-44
Preclinical Data to Support Human Studies of Immune Globulin Products.
H. Ko

B-45
Sunburn Cell Formation in Human Skin Induced by UV-exposure. Is this Process Dose-Rate Dependent?.
A. Kornhauser

B-46
In Vitro Percutaneous Absorption of Salicylic Acid in Hairless Mouse and Human Skin.
M. Kraeling

B-47
Evaluation of Genetic Stability of Chimera WN/DEN4-3'Delta30 the New Candidate of West Nile Vaccine.
M. Laassri

B-48
Residual Total Protein and Total Organic Carbon Levels on Reprocessed Gastrointestinal (GI) Biopsy Forceps.
S.K. Lappalainen

B-49
Residual Total Protein and Total Organic Carbon Levels on Reprocessed Bidirectional Steerable Cardiac Ablation Catheters.
S.K. Lappalainen

B-50
Combined synthesis of multi-valent conjugate vaccines.
C.R. Lee

B-51
In Vitro Protection of Human Endothelial Cells from Adenovirus Vector Toxicity by Activated Protein C.
J.N. Lozier

B-52
Mild hyperthermic incubation can potentiate the cytotoxicity of exogenous compounds and medical device extracts.
A.D. Lucas

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. Madson

B-54
Negligible Risk of Integration of Plasmid-based Vaccines Delivered with Cationic Lipid- and Poloxamer-based Formulations or with Electroporation.
R.K. Mahajan

B-55
Some Suggestions for Non-clinical Testing of Topical Combination Products Developed From Marketed Drugs for the Treatment of Dermatomycoses.
D.K. Mainigi

B-56
Assessing the Potential of Cell Substrates Used for Vaccine Production to Propagate the Agents of Transmissible Spongiform Encephalopathies (TSEs).
O.A. Maximova

B-57
Comparison of antimicrobial susceptibility profiles among Salmonella spp. recovered from retail poultry, NARMS 2002-2004.
P. McDermott

B-58
Ampicillin and Gentamicin Resistance in E. coli from 1950 – 2002.
P. McDermott

B-59
Utilization of sucrose and D-serine in foodborne Escherichia coli pathogens.
A. Mukherjee

B-60
Threat Assessment of Potentially Emerging Salmonella Serovars Associated with Roma Tomato Outbreak and Egg Houses in the United States.
R. Nayak

B-61
Genotyping of measles virus in clinical specimens based on oligonucleotide microarray hybridization patterns.
A.A. Neverov

B-62
The Pathway and Expression of the Fusion Protein Von Willebrand Cleavage Protease ADAMTS13 in Human Cells.
J.M. Newell

B-63
The Effect of Cyclosporine A on ADAMTS13 Metalloprotease.
J.M. Newell

B-64
Deaths due to transfusion-transmitted Klebsiella pneumoniae, 1995-2004.
M.T. Niu

B-65
Comparison of 3M Petrifilm Environmental Listeria Plates with Selective Enrichment Methods for the Detection and Recovery of Listeria monocytogenes on Environmental Surfaces.
D.G. Nyachuba

B-66
Development of human cell based safety evaluation assay for N. meningitidis Group B non-capsular vaccines.
M. Paul-Satyaseela

B-67
Studies on SV40: Development of Neutralization Assays for Primate Polyomaviruses and the Isolation of New Strains of SV40.
K. Peden

B-68
Translational Control of the SARS Coronavirus.
E. Plant

B-69
West Nile Virus adheres to human red blood cells (RBC) in whole blood.
M. Rios

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. Rios

B-71
Genetic Variability in West Nile Virus (WNV) Isolates From Blood Donors Specimens From 2002 - 2005 USA Epidemics.
M. Rios

B-72
Histopathological Effects of Acute Toxicity of Colchicine (COL) and Lipopolysaccharide (LPS) in Young Adult Rats.
M.G. Robl

B-73
Application of OECD Guideline 425 (UP and Down Procedure) to Establish Dose Range for Toxicity Study.
M.G. Robl

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. Wiesenfeld

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

B-76
Moving to molecular biology-based pre-clinical vaccine safety testing: Understanding the viral genetics of mumps virus neurovirulence.
C.J. Sauder

B-77
RNA interference in Trypanosome: A tool to study pathogenesis in Leishmania.
A. Selvapandiyan

B-78
A new antivirual pathway that mediates HCV replicon interferon sensitivity through ADAR1.
E. Silberstein

B-79
Development of Plasmid DNA Vaccines Against Highly Pathogenic H5N1 Avian Influenza Viruses.
L.R. Smith

B-80
The adenoviral fiber shaft is a major determinant of Kupffer cell necrosis.
J.S. Smith

B-81
Acute Toxicity of Sodium Arsenite in a Complex Food Matrix.
R.L. Sprando

B-82
The rubella virus nonstructural protease recognizes itself via an internal sequence present upstream of the cleavage site for trans-activity.
C. Stark

B-83
Prevalence and Antimicrobial Resistance of Campylobacter Isolated from Retail Meat and Poultry, NARMS 2004.
A.A. Stearns

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. Tang

B-85
Evaluation of Nanomaterials’ Immunotoxicity: Example of Polystyrene Nanoparticles.
V.J. Tomazic-Jezic

B-86
Recovery of Listeria monocytogenes from Environmental Swabs.
M.L. Tortorello

B-87
The identification of antibacterial compounds for the development of enhanced media for the detection of foodborne fungi.
V. Tournas

B-88
Moulds, yeasts and aerobic plate counts in medicinal herbal teas and coffee substitutes.
V. Tournas

B-89
Enhancement of Salmonella Enteritidis isolation from shell eggs using Ferroxiamine E.
I.E. Valentin-Bon

B-90
Medicinal Chemistry of Uncaria tomentosa, Lepidium meyenii, and Croton lechleri.
L.G. Valerio Jr., Ph.D.

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

B-92
The Hairless Guinea Pig as an Animal Model for Identifying Indirect Photosensitizers.
W. Wamer

B-93
Protective effect of midazolam on ketamine-induced neurotoxicity in rat forebrain culture.
C. Wang

B-94
Antimicrobial Resistance among E. coli Isolates Recovered from Retail Foods of Animal Origin, NARMS 2004.
D.G. White

B-95
VEGF and anti-restenotic drugs induce a prothrombotic state in endothelial cells.
S.C. Wood

B-96
Percutaneous Absorption of Retinol in Fuzzy Rat (In Vivo and In Vitro) and Human Skin (In Vitro) From Cosmetic Vehicles.
J. Yourick

B-97
Nitric Oxide-Associated nephrottoxicity in juvenile rats treated with gentamicin.
J. Zhang

B-98
A poinflammatory role of mast cell degranulation (MCD) in drug-induced vascular injury in sprague-dawley rats.
J. Zhang

B-99
Characterization Salmonella enterica serovar Heidelberg from Retail Meat Samples: National Antimicrobial Resistance Monitoring System (NARMS): 2002-2004.
S. Zhao

B-PO-101
Interactive cytotoxicity of phthalate monoesters in Jurkat lymphoma cells.
R. Brown

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.
L.H. Garthoff

B-PO-103
Solar UV doses of young Americans are inadequate for sufficient vitamin D3 production.
D.E. Godar

B-PO-104
Solar UV doses of adult Americans are inadequate for sufficient vitamin D3 production.
D.E. Godar

B-PO-105
Campylobacter jejuni Induce Maturation and Cytokine Production in Human Dendritic Cells.
L. Hu

B-PO-106
Development of a Real Time PCR Method for the Detection of Yersinia enterocolitica in Green Leafy Vegetables.
A. Rodriguez

B-PO-107
Evaluation of efficacy of quaternary ammonium compounds as disinfectant to inactive Enterobacter sakazakii - Preliminary Study.
K. Song

B-PO-108
Inactivation of Enterobacter sakazakii vegetative cell to sodium hypochlorite and comparison of biofilm formation on various different conveyor belt chips.
K. Song

B-PO-109
Multi-detection system for E. coli O157:H7 and Salmonella Enteritidis using by quantum dots as nanotechnology -Preliminary Study.
K. Song

B-PO-110
Removal and inactivation of Bacillus anthracis spores using by various commercial disinfectants.
K. Song

B-PO-111
Comparison of FDA method and Real-Time PCR for the detection of Enterobacter sakazakii in powdered infant formula- Preliminary Study.
K. Song

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. Song

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. Volokhov


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C. BIOLOGICAL ENDPOINTS, BIOMARKERS, SURROGATE MARKERS, AND IMAGING TECHNOLOGIES

C-01
NMR and MS Metabolic profiles of lipids in plasma from human pancreatic cancer and control patients.
R.D. Beger

C-02
A data-based assessment of alternative strategies for identification of potential human cancer hazards.
N.G. Doerrer

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. Goering

C-04
Preliminary Evaluation of an Early Surrogate Marker for Successful Laser Treatment in Ovine Hyaluronidase-Treated Subjects with Diabetes and Severe Vitreous Hemorrhage.
J.A. Gow

C-05
Examination of the Female Sprague-Dawley Rat as a model of Rosiglitazone-Induced Toxicity.
E. Herman

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

C-07
Progress in Developing Imaging Biomarkers for Parkinson’s Disease (PD).
C.S. John

C-08
Role of Interleukin-4/13 Receptors as Potential Biomarkers of Disease in Human Bladder carcinoma in situ.
B.H. Joshi

C-09
Differential Effect of Collagen and Alginate Gels on Chondrocyte Growth and Phenotype Expression.
D.S. Kaplan

C-10
IN-SITU PERFUSION OF RAT MESENTERY WITH DRUGS TO EVALUATE ROLE OF MAST CELL DEGRANUALTION IN EARLY MESENTERIC VASCULAR INFLAMMATION.
A.D. Knapton

C-11
Screening for Malarial Antibodies as a Criterion to Guide Donor Deferral Policy for Malaria Risk.
S. Kumar

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. Leakey

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. Lyn-Cook

C-14
An operational FDG/PET-CT protocol for drug development in oncology.
R.P. Maguire

C-15
Cytochrome c: A Non-Invasive Biomarker Of Drug-Induced Liver Toxicity.
T.J. Miller

C-16
Optical Properties of Nanoshells for Diagnostic Imaging.
J. Pfefer

C-17
The Role of CDc42 in the Development of Human Breast Cancer.
Y. Shen

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. Shimamura

C-19
Risk of Local Adverse Events by Gender Following Cardiac Catheterization.
D.R. Tavris

C-20
A Cost-Benefit Approach to the Regulation, Qualification and Acceptance of Biomarkers and Surrogate Endpoints.
S.A. Williams

C-21
Use of “DNA Barcoding” to Detect Adulteration of Star Anise (Illicium verum) by Other Illicium Species.
G.C. Ziobro


TOP

D. GENOMICS, PROTEOMICS, PREDICTIVE TOXICOLOGY AND MODELING

D-01
Scientific and Regulatory Challenges of Endocrine Disruptors: Human Food Safety Considerations.
M.C. Aguila

D-02
The History of Voluntary Genomic Data Submissions (VGDS) at the U.S. FDA.
S.G. Amur

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.G. Amur

D-04
Genomic Biomarkers in FDA-approved drug labels.
S.G. Amur

D-05
Pharmacogenomic Information in Drug Labels: Using a Relational Database to Integrate Genetic and Genomic Information with Chemical, Biochemical, and Clinical Information.
S.G. Amur

D-06
A Proteomic Analysis of the Thermoregulation of Shigella Virulence Factors.
R.L. Bell

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. Binienda

D-08
‘Omics’ Technologies Enabling the 3Rs in Drug Discovery and Development: Treating Human Disease by Studying Humans.
S. Dhruvakumar

D-09
Prioritizing sources of variability in genomic microarray data (OSHC inter-center project).
R.K. Elespuru

D-10
The National Center for Toxicological Research. ...research innovations for public health.
T.J. Flammang

D-11
2D and 3D QSAR Models for Prediction of hERG K+ Channel Inhibition.
G. Fraczkiewicz

D-12
New empirical method obtains partial atomic charges from 2D inputs and improves some predictive ADMET models.
R. Fraczkiewicz

D-13
Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model (OWH Project).
J.C. Fuscoe

D-14
Quality Prediction of Cell Substrate Using Gene Expression Profiling.
J. Han

D-15
Optimization of hybridization and washing conditions to improve the reproducibility and accuracy of DNA microarray quantification.
T. Han

D-16
Drug-metabolizing enzymes: Evidence for clinical utility of pharmacogenomic tests.
S. Huang

D-17
Insights into the mutator phenotype: Global gene expression in MMR-defective Salmonella enterica using DNA microarrays.
S.A. Jackson

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

D-19
Microarray based detection and identification of foodborne viruses.
B.B. Goswami

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. Kotewicz

D-21
Genomic comparisons of antibiotic susceptible and resistant Salmonella Newport strains.
M.K. Mammel

D-22
Development of a QSAR Weight of Evidence Model for Reproductive and Developmental Toxicity Hazard Identification.
E.J. Matthews

D-23
Structure Activity Relationship Analysis Tools: Validation and Applicability.
J.N. Mayer

D-24
Importance of Data Filtration in the Analysis of Voluntary Genomic Data Submission (VGDS) data - An Example.
A. Men

D-25
Development of Microarray Standards and Procedures for Analyzing Clinical Samples.
R.K. Panguluri

D-26
Metabonomics Applied to a Rodent Pediatric Nephrotoxicity Model.
L. Schnackenberg

D-27
Oligo Design: Software for DNA Sequence Analysis including PCR Primer and Microarray Probe Design.
N.V. Sergeev

D-29
Molecular Characterization of the Canine Factor VIII Gene and Duplicated Sequences Related to a Common Gene Inversion Mutation.
N. Tayebi

D-30
Characterization of Alterations in Rat Liver Microarray Data Induced by Tissue Handling.
K.L. Thompson

D-31
Evaluation of the Age-Dependent Nephrotoxicity of Gentamicin Using Gene Expression Biomarkers.
K.L. Thompson

D-32
The Global Ratio as a Quality Control Metric for Microarray Data.
K.L. Thompson

D-33
A Baseline Animal Microarray Database for Biological Response Identification and Biomarker Validation.
K.L. Thompson

D-34
Genetic Associations in Clinical Trials: Some Issues in Design and Analysis.
J. Tiwari

D-35
NCTR Center for Toxicoinformatics – A Bioinformatics Resource for Genomics, Proteomics, Metabolomics and Predictive Toxicology.
W. Tong

D-36
Comparison of Artificial Neural Network and Support Vector Machine Ensemble Models.
D. Zhuang

D-38
Sex Differences in CYP3A Activity Using Intravenous and Oral Midazolam.
M. Chen

D-PO-37
The E. coli lac operon: Why?.
R.L. Bernstein


TOP

E. PREDICTIVE PHARMACOKINETICS AND PHARMACODYNAMICS

E-01
Effect of a Potent CYP3A Inhibitor Ketoconazole on Interindividual Variability of CYP3A Activity as Measured by Oral Midazolam.
M. Chen

E-02
Exposure-Response Relationship for an Anti-Infective in an Animal Infection Model versus Patients.
C.R. Bonapace

E-03
Excel and Visual Basic software can be used to develop a physiologically-based pharmacokinetic (PBPK) model for ethylene oxide.
R. Brown

E-04
Comparison of Bovine In Vivo Bioavailability of Two Sulfamethazine Oral Boluses Exhibiting Different In Vitro Dissolution Profiles.
R.M. Fahmy

E-05
PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR THE INHIBITION OF MIDAZOLAM CLEARANCE BY ERYTHROMYCIN AND DILTIAZEM.
C. Gorski

E-06
Simulation of Midazolam Absorption and Bioavailability in Pediatric Patients.
V. Lukacova

E-07
Epidemiological cut-off values for four antimicrobial agents against Aeromonas salmonicida isolates using MIC and zone diameter frequency distributions.
R.A. Miller

E-08
Pharmacokinetics of Gabapentin Injection in Cerebrospinal Fluid and Plasma with Intrathecal Administration.
L.M. Page

E-09
Improving Pediatric Dosing Through Pediatric Initiatives – What We Have Learned.
W.J. Rodriguez

E-10
Parameter Sensitivity Analysis and Virtual Trial of Oral Cyclosporine Capsule.
P.M. Sathe

E-11
Metabolism and residue depletion of [3]H-ivermectn in the muscle tissue of rainbow trout after oral administration.
B. Shaikh

E-PO-12
Distribution of Androstenedione and Its Related Steroids in Pregnant Rats.
I.A. Ross


TOP

F. MEDICAL PRODUCT DESIGN, CHARACTERIZATION, AND MANUFACTURING

F-01
STEALTH NANOPARTICLES FOR THE FABRICATION OF DRUG DELIVERY DEVICES.
E.O. Akala

F-02
A Multiplex PCR Microarray Assay for Screening Blood.
R.C. Duncan

F-03
Analysis of Oligomeric Organosilsesquioxanes by MALDI-TOF Mass Spectrometry.
M. Farahani

F-04
Development of a Novel Technology to Measure Impaction Force of Nasal Sprays and Metered-Dose Inhalers Using the Texture Analyser.
C. Guo

F-05
Simple confocal microscopy based on single hollow-core photonic bandgap fiber.
D. Kim

F-06
Characterizing Reflections from Intraocular Lens Implants.
R.J. Landry

F-07
Establishment of design space for a modified-release Zidovudine microsphere dosage form.
D.R. Lu

F-08
A new robotic approach for high-throughput screening of unique Trazodone salts.
D.R. Lu

F-09
New lipoprotein mimics as novel nanoscale DNA vaccine delivery carriers.
D.R. Lu

F-10
Evaluation of platelet activation in medical devices.
Q. Lu

F-11
Reversal of Chronic Hypotension by Non-Invasive Plantar Stimulation.
G. Madhavan

F-12
Optimization of cyclosporine A self-nanoemulsified drug delivery systems using Box-Behnken design and desirability function.
A. Nguyenpho

F-13
Micro Structure Development and Release Behavior in Controlled Drug Delivery Systems.
D.V. Patwardhan

F-14
Effect of Materials Selection in Controlled Drug Delivery Systems: (Bio)Degradable v. Non-Degradable Polymers.
D.V. Patwardhan

F-15
In Vitro Characterization of Fentanyl Transdermal Systems.
S. Prodduturi

F-16
Vacuolar Growth in Foldable IOLs: Toward a Preclinical Test.
S. Salas-Vega

F-17
Modeling Time-dependent and Cycle-dependent Capacity Fade in Rechargeable Lithium-ion Batteries in an Implantable Neurostimulator.
C.L. Schmidt

F-18
Formulation, Evaluation and Progress of Emulsion Formation of an Alternative Self-Nanoemulsified Drug Delivery System of Cyclosporine A.
R. Shah

F-19
Physical Properties of Abdominal Adhesion Barriers.
K. Vorvolakos

F-20
The Effects of Position with Respect to the Heart on Pulse Oximetry Measurements.
S. Weininger

F-22
Synthesis and Characterization of an Iron-Crosslinked Hyaluronic Acid-Based(FeHa) Adhesion Barrier.
I. Isayeva

F-PO-21
Disulfide bonds do not influence proteolytic digestion patterns of alpha-1-PI polymers*.
E. Marszal


TOP

G. BIOSTATISTICS AND DESIGN AND EVALUATION OF CLINICAL TRIALS

G-01
Coding of Indicator Variables When There Is an Interaction Term. A Cautionary Tale.
P.E. Bonangelino

G-02
Emerging Trends in Clinical Trial Data Integration and Management.
P. Chakraborty

G-03
Crossover Designs for Drug Abuse potential Clinical Trials.
L. Chen

G-04
Comparing Diagnostic Sensitivities With a Doctor in the Loop.
B.D. Gallas

G-05
Conservative or anti-conservative?: ITT and PP approach in RCT.
Y. Gao

G-06
Estimating the Relative Efficiency of Odds Ratio Estimates by the Bootstrap Technique.
Q.F. Graves

G-07
Toward an integrated analysis of risk and benefit in clinical research.
S. Hirschfeld

G-08
Calculation of Z Values for a Phase 1 Alanine Aminotransferease Data Set.
G. Kapke

G-09
Gender-specific statistical models of pathological coronary arteries for generating simulated angiograms.
I.S. Kyprianou

G-10
Evaluating Multiple Endpoints Collectively in Clinical Trials.
Q.H. Li

G-11
Statistical Considerations in the Evaluation of RBC Products.
T. Ng

G-12
Can “Weight Only” Method be Used to Determine the Post-Filtration Red Blood Cell In Vitro Recovery for Quality Control Validation?.
T. Ng

G-13
Frequentist and Bayesian are Complementing Each Other.
T. Ng

G-14
Simultaneous Testing of Noninferiority and Superiority increases the False Discovery Rate.
T. Ng

G-15
Comparing Image Detection Algorithms using Resampling.
F.W. Samuelson

G-16
Interchangeability of the two measurement systems of the anthrax vaccine potency: Toxin Neutralization Assay and ELISA.
L.A. Sirota

G-17
ON ESTIMATION OF THE PROPORTION OF TREATMENT BENEFIT WITH A CONTINUOUS RESPONSE WITHOUT DICHOTOMIZATION.
Y. Tsong

G-18
DEPENDENCY OF NON-INFERIORITY TRIALS.
Y. Tsong

G-19
SEQUENTIAL ADAPTIVE SAMPLE SIZE RE-ESTIMATION FOR PAIR-MATCHED BINARY DATA.
Y. Tsong

G-20
AN ALTERNATIVE APPROACH TO ASSESS EXCHANGEABLILITY OF A NEW TEST TREATMENT.
Y. Tsong

G-21
Non-inferiority testing with a variable margin.
Z. Zhang

G-22
Statistical Considerations for Lot Release Sampling Procedures.
B.A. Zhen

G-PO-23
Issues of a Thorough QT/QTc study.
J. Zhang


TOP

H. PROCESS ANALYTICAL TECHNOLOGY (PAT) AND PHARMACEUTICAL TECHNOLOGY

H-01
PAT for Monitoring the Blend Homogeneity of an Active in a Tumble Mixer: Feasibility Studies and Real Time Experience.
M. Ashraf

H-02
Control of Particle Size Distribution using PAT.
S.H. Bhansali

H-03
ReactIR as a PAT Tool for the Online Reaction Monitoring of a Boronate Intermediate in the Manufacture of Temsirolimus.
W. Chew

H-04
PAT tools for evaluation of drug substance crystallization.
S.S. Deshmukh

H-05
The Impact of Segregation on Spectroscopic Process Measurements.
C.D. Ellison

H-06
Characterizing the Impact of Wall and Powder Friction on Tablet Uniformity as Measured by Shear Cell and Chemical Imaging.
C.D. Ellison

H-07
Process Analytical Technology and Rapid Microbiological Methods using the Chemunex Scan RDI.
M.A. Farris

H-08
Monitoring of manufacturing changes and formulation excipients on solid oral dosage forms of furosemide using chemometrics and laser-induced breakdown spectroscopy (LIBS).
P.J. Faustino

H-09
Thermal Effusivity Application as a PAT Tool to Monitor and Control Roller Compaction Processes.
M.K. Ghorab

H-10
Residual Solvent Drying Endpoint Detection Using Process Mass Spectrometry.
G. Glasier

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

H-12
Imaging-Based Algorithms for Determining the Uniformity of Drug Products and Blends.
M.L. Hamad

H-13
Near-infrared Transflectance Spectroscopy for the Quantitative Assessment of Gabapentin Concentration in Aqueous Solution.
M.L. Hamad

H-14
Application of NIR Spectroscopy for the Monitoring of Tablet Coat Thickness and Prediction of Drug Release from Different Acrylate Copolymers.
S. Hassannejad Tabasi

H-15
Development of a Chemometric Model to Evaluate Prussian Blue Product Quality using Near-Infrared Spectroscopy.
E.H. Jefferson

H-16
On-line particle size analysis for a roller compaction process.
M. Krishnan

H-17
Process Monitoring of Pilot-Scale Pharmaceutical Blends: FDA-Pfizer CRADA Study.
R.C. Lyon

H-18
PAT: Prediction of porosity, hardness, and content of metoprolol tartrate tablets by chemometric analysis.
R. Shah

H-19
Acoustic Viscometry of Topical Preparations.
J.A. Spencer

H-20
Terahertz Spectroscopy for Pharmaceutical PAT Applications: Optimizing Measurement Process Conditions.
H. Wu

H-21
Terahertz Spectroscopy for Pharmaceutical PAT Applications: Quantification Methods for Studying Theophylline Tablet Compositions.
H. Wu

H-22
Regulatory and Engineering Considerations for Multivariate Modeling of Tablet Dissolution.
H. Wu

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. Xie

H-24
Applications of Conventional and Environmental Scanning Electron Microscopy (SEM/ESEM) in Pharmaceutical Development.
Y. Xu


TOP

I. RISK MANAGEMENT, RISK ASSESSMENT,AND RISK COMMUNICATION FOR MEDICAL PRODUCTS AND FOODS

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. Arvidson

I-02
Egg Allergy: An Assessment of the Health Hazard.
S. Assimon

I-03
Use of a Free, Publicly-Accessible Data Source to Estimate Hospitalizations Related to Adverse Medical Device Events.
R.A. Bright

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.
A.D. Brinker

I-05
Risk of TSE transmission from reprocessed neurosurgical instruments is low.
R. Brown

I-06
Aggregate safety assessment for co-exposure of patients to DEHP and MEHP released from PVC medical devices.
R. Brown

I-07
Effect of sterilization process on the formation of mono(2-ethylhexyl) phthalate (MEHP) from di(2-ethylhexyl) phthalate (DEHP).
R. Brown

I-09
Variation in Salmonella Serotype Distributions and Antibiotic Susceptibility Profiles with Environmental Source of the Isolates.
P.J. Carter

I-10
An Assessment of the Cancer Risk of Ochratoxin-A, a Fungal Toxin and Food Contaminant.
H.A. Clark

I-11
Risk-Informed Decision Support for Pre-Approval Inspection (PAI) Decisions.
G. Claycamp

I-12
Risk Factors for Animal Drug and Feed Products, Manufacturing Processes and Facilities: Analysis of Recalls, 2000 – 2005.
K.B. Ekelman

I-13
Trends in outpatient prescription usage in the U.S., 2002 – 2005.
L.A. Governale

I-14
Effect of Repackaging on Gabapentin Capsules.
A. Gupta

I-15
SMART Review Templates placing review resources at your fingertips: What are they and how do they work?.
K.A. Hollinger

I-16
Risk Analysis of Transdermal Drug Delivery Systems (TDDSs).
M. Kakhi

I-17
Menopause and Hormones Communications Outreach Campaign.
D.L. Kallgren

I-18
Adherence to Metoclopramide Duration of Use Recommendation: Claims Data Study.
S. Kaplan

I-19
Alpha-1 Proteinase Inhibitor (Human) Product Postmarketing Safety Surveillance.
T. Khoie

I-20
INVESTIGATION OF SIMIAN FOAMY RETROVIRUS TRANSMISSION BY BLOOD IN RHESUS MACAQUES.
D. Kumar

I-21
QT Interval Prolongation Following Coadministration of Two Drugs With Documented QT Effects.
S. Lee

I-22
Live Microbial Ingredients in Dietary Supplements.
D.D. Levy

I-23
Improving Interagency Communication on Food Safety: Interagency Risk Assessment Consortium.
W.R. Long

I-24
CDER's Drug Safety Oversight Board.
M.L. Mease

I-25
Blood use patterns among U.S. elderly during 2001.
M. Menis

I-26
Benchmark Dose Analysis of in vivo Genotoxicity Data Can be Used to Inform Cancer Risk Assessment.
M.M. Moore

I-27
Bleeding complication associated with patients on warfarin treated at emergency departments.
P. Nourjah

I-29
Developmental Neurotoxicity Assessment of Acrylamide in Fischer 344 Rats.
M.G. Paule

I-30
What makes public issue communication more effective? – Exploring information format effects.
W. Qin

I-31
Stability study of ranitidine hydrochloride syrup drug product in bulk and repackaged containers.
R. Shah

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

I-34
Seafood-Related Outbreaks, 1990-2003.
C. Smith DeWaal

I-35
Salmonella on Produce: Outbreaks from 1990-2003.
C. Smith DeWaal

I-36
Guidewire-related Adverse Event Reports in 2005: A Descriptive Analysis.
R.A. Sullivan

I-37
“Take Time to Care”: Providing Essential Risk /Benefit Information to Women through FDA Office of Women’s Health Outreach.
K.A. Thomas

I-38
MedDRA Processing of Adverse Event Reports in the Veterans Health Administration Pharmacy Benefits Management Adverse Drug Event Program.
A. Vega

I-39
COMPARATIVE STABILITY OF WHOLE AND SPLIT GABAPENTIN TABLETS.
D.A. Volpe

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

I-41
Adverse Events Associated with Vacuum-Assisted Delivery Devices.
B. Wang

I-42
Anaphylactoid Reactions to Dextran 40 and 70: Reports to the US Food and Drug Administration (FDA), 1969-2004.
C.E. Zinderman

I-PO-08
Development of a Tolerable Contact Limit (TCL) for ethylene oxide residues on sterilized medical devices.
R. Brown

I-PO-28
Gender-Differential Drug Risk Evaluation in Adolescents and Young Adults: Examination of Top 30 Drug Prescriptions Data.
R. Ouellet-Hellstrom

I-PO-33
Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender.
A. Shoaibi


TOP

J. COUNTERTERRORISM AND EMERGENCY RESPONSE

J-01
Hurricane Response 2005: PHS Commissioned Corps Officers on the Front Lines.
S. Caviness

J-02
Development of a Transportable System for Radionuclide Analysis.
W.C. Cunningham

J-03
Simultaneous Detection of Abrin, Botulinum Toxin, Ricin, and Staphylococcus Enterotoxin B (SEB) in Beverages Using Luminex Multiplex Technology.
E.A. Garber

J-04
Elimination of Wheat Lectin-based False Positives Associated with Lateral Flow Devices for Detection of Ricin and Staphylococcus Enterotoxin B.
E.A. Garber

J-05
Detection Of Abrin In Foods Using ELISA and Electrochemiluminescence (ECL) Technologies.
E.A. Garber

J-06
Effects of Cooking on Detection & Toxicity of the Beans from Abrus Precatorius.
E.A. Garber

J-07
Evaluation of the FDA-FERN Screening Method Developed for the Isolation and Identification of Yersinia pestis from Foods.
D.E. Hanes

J-08
Discrimination of Shigella sub-groups and strains by identification of single nucleotide polymorphisms.
A.E. Hayford

J-09
US Public Health Service Hurricane Katrina Response – PMAC Pharmacy.
C.T. Jung

J-10
Recovery of Bacillus anthracis from Various Artificially Contaminated Foods Using Cultural and PCR Methodologies.
S.M. Madson

J-11
Environmental Effects on the Operation of Lateral Flow Devices (LFDs) used in the Detection of Ricin in Foods.
M. McLaughlin

J-12
Effect of Toxic Chemicals on the Conductivity of Liquid Foods.
W. Mindak

J-13
Distribution coefficients for alpha-Amanitin, Ricin and T-2 toxin in milk and salad dressings.
H. Njapau

J-14
Effects of Food Preparation and Lactose on the Detection and Lectin Binding Ability of Ricin B-Chain.
G.M. Orlowski

J-15
Microarray-Whole Genome Amplification based analysis of bacterial pathogens.
N.V. Sergeev

J-16
Rapid microbial pathogen DNA amplification using a battery-powered thin-film resistive heater thermocycler.
N.V. Sergeev

J-17
CFSAN Outbreak Surveillance Database: Outbreaks and illnesses reported for 2004 and 2005.
K. Vierk

J-18
Contributing Factors (CFs) Identified in Produce-Associated Outbreaks from CDC's National Electronic Foodborne Outbreak Reporting System (eFORS), FoodNet Sites, 1999-2002.
P.V. McCarthy

J-19
Evaluating the use of fatty acid profiles to identify Francisella tularensis.
P. Whittaker

J-PO-20
APPLICATION OF PEDXRF TO RAPID SCREENING OF TOXIC ELEMENTS IN FOODS AND ASIAN PATENT MEDICINES.
R.M. Jacobs

J-PO-21
Development and Comparison of Enrichment Media for the Isolation of Yersinia pestis from Lettuce.
S.D. Torosian


TOP

K. REGULATORY SCIENCES, SCIENCE COMMUNICATION, POLICY, LEVERAGING, OUTREACH

K-01
Dermal Sensitization Quantitative Risk Assessment QRA) For Fragrance Ingredients.
A. Api

K-02
What is FDA doing about indoor tanning?.
J.Z. Beer

K-03
Development and Regulation of Nicotine Replacement Therapy Products from Natural Tobacco.
J.H. Boal

K-04
Emerging Delivery Systems of Fentanyl and Their Regulation.
J.H. Boal

K-05
Inter-Center Modeling Consortium.
I. Chang

K-06
Pharmaceutical Development Report in the Assessment of Pharmaceutical Quality in an NDA.
D.D. Christodoulou

K-07
Home Use Devices: Using a Public-Private Partnership to Address Gaps in Information.
A.A. Ciarkowski

K-08
Measuring Citizen Satisfaction with FDA E-mail Performance Standards.
K.C. Dada

K-09
FDAMA Section 113: sponsor compliance with listing trials in ClinicalTrials.gov.
J.M. Derbis

K-10
Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims.
B.M. Derby

K-11
INTERNATIONAL HARMONIZATION OF TESTING FOR PHARMACEUTICALS: ANIMAL PROTECTION AT THE ICH.
S. Dhruvakumar

K-12
Utilization of antiplatelet therapy with drug-eluting coronary stent implantation.
H.J. Duggirala

K-13
The President’s Emergency Plan for AIDS Relief (PEPFAR) Program: Involvement of the FDA's Office of Generic Drugs.
B.F. Fritsch

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.
H.A. Hahm

K-15
Heparin and its Fragments: Scientific and Regulatory Challenges.
R.S. Harapanhalli

K-16
Risk Management of Warfarin Overanticoagulation: Role of Pharmacogenomic Information.
S. Huang

K-17
Drug-Drug, Drug-Dietary Supplement, and Drug-Citrus Fruit and Other Food Interactions- Labeling Implications.
S. Huang

K-18
In-hospital Mortality Following Hip Replacement: Results of a Nationally Representative Survey.
R.G. Kaczmarek

K-19
Regulatory Framework for Positron Emission Tomography Drugs.
R.K. Kasliwal

K-20
Systems Biology and the FDA Review Process.
M. Katzper

K-21
Dynamic Responses to Drug Interventions.
M. Katzper

K-22
Committee for the Advancement of FDA Science (CAFDAS): The FDA Scientist’s Liaison to the Commissioner’s Office.
M. Major

K-23
Improved Methods for Determining Compliance with Global Food Contact and Food Additive Requirements through Government Industry Collaboration.
L.M. Marchant

K-24
Improving Quality of Care in Sickle Cell Disease Patients: Key to Managing an Otherwise Painful Disease.
N.C. Mezu-Nwaba

K-25
Comparison of different UV exposure regimens for cosmetic tanning.
S.A. Miller

K-26
Burns in MRI patients wearing transdermal drug delivery systems.
A.K. Mitra

K-27
A repository of clinical pharmacokinetics data for drugs used in pregnancy and lactation developed at FDA.
S.C. Nallani

K-28
High Field NMR and Characterization of Polysaccharide Vaccines.
S.E. Norris

K-29
The Office of Women’s Health: Impact of Research Program.
D. Obias-Manno

K-30
Comparison of Ethinyl Estradiol Pharmacokinectics in Combined Hormonal Contraceptives.
J.Y. Park

K-31
Bioequivalence Issues of Highly Variable Drugs in Generic Drug Applications.
D. Patel

K-32
Contraception Requirements for Participation in Clinical Trials.
E.E. Pinnow

K-33
Using the CFSAN Thesaurus to Improve Scientific Communication II.
D.M. Schmit

K-34
CHARACTERISTICS OF DONORS IMPLICATED IN FATAL TRANSFUSION RELATED ACUTE LUNG INJURY (TRALI) REACTIONS.
L. Simmons

K-35
19-YEAR REVIEW OF FATALITIES DUE TO CONTAMINATED BLOOD AND BLOOD COMPONENTS.
L. Simmons

K-36
Revised Consumption Factor for Polystyrene.
K.A. Smeds

K-37
FDA's MedWatch Program.
J. Spearmon

K-38
FDA's Office of Oncology Drug Products.
O.H. Suleiman

K-39
Product development considerations: integrated diagnosis treatment combinations.
M.E. Van Hoef

K-40
Food Allergen Advisory Statements on Food Labels: Consumer Preferences versus Effectiveness.
L. Verrill

K-41
Scientific Perspectives on Drug Transporters and Their Role in Drug Interactions.
L. Zhang

K-42
Datamining the FACTS Database for Trends in Food Adulteration Due to Filth.
G.C. Ziobro

K-PO-43
Tyrosine Kinase Inhibitors.
X. Chen

K-PO-44
Regulatory Perspectives of Type II Prodrug Development: Preclinical Pharm/Tox Analysis and the Role of Comparative Toxicology. Kuei-Meng Wu and James G. Farrelly, DAVP/ODEIV/OND/CDER/FDA.
K. Wu


TOP

L. VALIDATION, TESTING, STANDARDIZATION, AND QUALITY ASSURANCE

L-01
Calibration Standards Needed for Standardization of Clinical Multicolor Flow Cytometry:.
F. Abbasi

L-02
COMPARATIVE STABILITY STUDY OF REPACKAGED FUROSEMIDE TABLETS.
E.B. Asafu-Adjaye

L-03
Measles Neutralizing Antibodies in Intravenous Immunoglobulins.
S. Audet

L-04
Heat Penetration Parameters: A Comparative Study between “Remote” Temperature Sensors and T-Type Thermocouples.
G.B. Awuah

L-05
BONE DENSITY AFFECTS RELATIONSHIP BETWEEN CEMENT DOSE AND MECHANICAL STRENGTH AFTER VERTEBROPLASTY.
B.D. Buch

L-06
Testing the immunity of medical devices to continuous wave magnetic fields by immersion method.
V. Buzduga

L-07
Development of In Vitro Peel Adhesion Testing for Transdermal Drug Delivery System.
B. Cai

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

L-09
Critical Path Initiative: Comparisons between Simulated Night Driving Performance and Clinical Tests of Visual Acuity, Glare, and Contrast Sensitivity.
B.A. Drum

L-10
Evaluation of VIDAS® Immuno-Concentration Salmonella (ICS) and VIDAS® Salmonella Immunoassay (SLM) for rapid detection of Salmonella spp. in selected foods.
W.M. Fedio

L-11
Detection of Shigella spp. by selective plating and PCR after aerobic enrichment in Shigella Broth.
W.M. Fedio

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

L-13
Comparison of Antimicrobial Susceptibility Testing Methods for Salmonella enterica serotype Heidelberg Isolates.
S. Foley

L-14
Comparison of Three Techniques for the Post-Immunomagnetic Separation Detection of Cryptosporidium parvum in Foods and Beverages.
C. Frazar

L-15
Effect of heat treatment on the quantitative detection of egg proteins using commercial ELISA kits.
T. Fu

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. Fu

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. Fu

L-18
Effects of extraction methods in quantitative determination of glutens in food using commercial test kits.
T. Geng

L-19
A procedure for acoustic power calibration of high intensity focused ultrasound transducers using a radiation force technique.
G.R. Harris

L-20
Tissue mimicking materials for high intensity focused ultrasound surgery.
G.R. Harris

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

L-22
Towards the establishment of a valid quantitative molecular biology based pre-clinical safety test for mumps virus.
T. Malik

L-23
Studies on Cell Substrate Safety: Development of in vivo Assays to Assess the Oncogenic Activity of DNA.
K. Peden

L-24
Non-invasive Estimation of Sunscreen Efficacy by Diffuse Reflectance Spectroscopy.
J. Pfefer

L-25
In-Vitro Simulation of Adinazolam Mesylate Swellable HPMC Matrix Release using DDDPlus Software.
A. Prabhakaran

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. Ramirez

L-27
Detection of Type A, B, E and F Clostridium botulinum Neurotoxins In Foods Using Electrochemilumninescent Immunoassay.
S. Sharma

L-28
Single Laboratory Validation of Commercially available kits for the detection of Aflatoxin M1.
S. Trujillo

L-29
Ensuring Product Safety by Monitoring Anti-A and Anti-B Levels in US-Licensed Intravenous Immunoglobulin Products.
M.L. Virata-Theimer

L-30
MRI Safety of Medical Devices: Standard Test Methods and Terminology.
T.O. Woods

L-31
Comparative stability of repackaged metoprolol tablets.
Y. Yang

L-44
Development of a FACS based potency assay for immuno-modulatory therapeutics using phospho-specific antibodies.
L. Graham

L-PO-32
Effect of chiro-inositol and myo-inositol on the delay of cataractogenesis in vitro.
K. Song

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. Song

L-PO-34
Study on yoghurt manufactured from various concentrated raw milk using by ultrafiltration and its changes in quality during storage.
K. Song

L-PO-35
Study on evaluation for the quality and shelf life on Tofu made from soy milk added WPC and WP.
K. Song

L-PO-36
Study on the quality of yoghurt made from soy milk added skim milk and whey powder during storage.
K. Song

L-PO-37
Study on the separation of glycomacropeptide and beta-lactoglobulin from Mozzarella cheese whey, and its seasonal composition changes.
K. Song

L-PO-38
Study on the separation of glycomacropeptide and beta-lactoglobulin from Cheddar cheese whey.
K. Song

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.
K. Song

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.
K. Song

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.
K. Song

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. Song

L-PO-43
Protective effect of soy bean extractive pinitol on xylose induced sugar cataract in rates.
K. Song


TOP

M. ENGINEERING AND PHYSICS

M-01
The specific anthropomorphic mannequin (SAM) compared to 14 anatomical head models using a novel definition for the mobile phone positioning.
W. Kainz

M-02
The future of anatomical models - Anatomical CAD models for numerical dosimetry and implant evaluations.
W. Kainz

M-03
Potential Improvement of Computerized Mass Detection on Mammograms using a Bilateral Pairing Technique.
S. Paquerault

M-04
Evaluation of A Novel Reflectance-Based System For Optical Property Measurement.
J. Pfefer

M-05
Stability of Nano-Scale Constructs in Medical Device Applications.
D.M. Saylor

M-06
Distributed and Grid Computing Software Technologies for Simulation of Human Physiology.
Y.G. Tirat-Gefen

M-07
Mechanical performance of generic and proprietary enema bottles.
D. Walsh

M-08
Alignment of full and partial CT thoracic scans using bony structures.
M. Gavrielides


TOP

N. BIOENGINEERED TISSUES, BIOMATERIALS, STEM CELL AND OTHER CELLULAR PRODUCTS

N-01
Noninvasive Magnetic Resonance Imaging (MRI) of Cellular Trafficking in Immunodeficient Mice with Charge Neutral Gadolinium Complex.
M.K. Dewanjee

N-02
Testing alginate capsules for endotoxin stimulated inflammation.
D.B. Lyle

N-03
Glucose Sensing in Psammomys Obesus (Fat Sand Rat) and Possible Method for Converting Islets into the Diabetic State.
C. Zimliki


TOP

O. OBESITY AND NUTRITION

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.S. Calvo

O-02
Duration of use for the amphetamine congeners.
A.G. Feight

O-03
Antioxidant properties and phytochemical contents of cold-pressed onion, parsley, cardamom, mullein, roasted pumpkin, and milk thistle seed oils.
J.W. Parry


TOP

P. SCIENCE AT THE CENTENNIAL: HISTORY AND PERSPECTIVE

P-01
Color Additive Regulation: A History.
J.N. Barrows

P-02
Combating Health Fraud: Then and Now.
G. Coody

P-03
History of FDA’s Policy on Foods and Feeds Derived from Biotechnology.
M.D. Ditto

P-04
FDA’s Approach to the GRAS Provision: A History of Processes.
P. Gaynor

P-05
Developments in Cosmetics Regulation: A Historical Overview.
B.R. Meyers

P-06
USP and FDA: A Century of Collaboration.
J.R. Payette

P-07
Compendial Science and FDA: Promoting Public Health.
J.R. Payette

P-08
History of Infant Formula Regulation in the U.S. 1906 – 2006.
G.L. Robert-Baldo

P-09
History of the Internet at CFSAN.
D.M. Schmit

P-10
History of Computing at CFSAN.
D.M. Schmit

P-11
History of FDA's Voluntary Cosmetics Registration Program.
M.V. Waleski

P-12
B. J. Howard, More Then Mold Counts.
G.C. Ziobro

P-13
Bureau of Chemistry, Microchemical Laboratory: 102 Years of Research.
G.C. Ziobro

P-14
Health Sciences Luminaries Poster Series Project.
L. Robinson