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

A-01
Display contrast changes with viewing-angle in medical AMLCDs: measurement methods and effect on observer detection performance.
A. Badano

A-02
Metabolomics analysis to find biomarkers of disease state.
C.W. Beecher

A-03
NMR Metabonomics of Urine from Wistar Rats Dosed Separately with Kidney and Liver Toxicants.
R.D. Beger

A-04
Serological Attraction of Non-toxin Egg Protein to Staphylococcal Antienterotoxins.
R.W. Bennett

A-05
Graphical User Interface (GUI) for mammography review and CAD development.
S. Bhat

A-07
Predicting clinical resistance to Gleevec treatment by in vitro applied stable isotope-based dynamic metabolic profiling (SIDMAP).
L.G. Boros

A-08
Comparative Genomic Hybridization Using Oligonucleotide Microarrays and Total Genomic DNA.
L. Bruhn

A-09
Metabolite profiling for biomarker discovery and applications.
K. Busch

A-10
Molecular Network Analysis of Metastatic Colorectal Carcinoma Using Reverse Phase Protein Microarray Based Phosphoproteomic Portraits.
V.S. Calvert

A-11
Development of a mammalian retinal ganglion cell model of electrical stimulation.
E.D. Cohen

A-12
Automation: An Approach to Standardizing Multi-Functional Cellular Profiling Assays in Clinical Trials.
S. D'Costa

A-13
A Systems Biology Approach to Biomarker Discovery Utilizing Integrated Cytomic and Proteomic Techniques.
S. D'Costa

A-14
Cloning and Analysis of Mono-Specific Single Chain Fragment Variable (scFv) Fragments that Recognize German Cockroach Allergens Bla g 1, Bla g 2, Bla g 4, and Bla g 5.
N. deVore

A-15
A Low Molecular Weight, Orally Active TpoR Agonist, SB-497115, Does Not Prime Platelets for Activation or Agonist-Induced Aggregation In Vitro.
C.L. Erickson-Miller

A-16
AGE-RELATED DIFFERENCES IN SUSCEPTIBILITY TO TOXIC EFFECTS OF VALPROIC ACID IN SPRAGUE-DAWLEY RATS.
P. Espandiari

A-17
Pregabalin: Pharmacokinetics, Pharmacodynamics and Interspecies Scaling.
R. Feng

A-18
JIFSAN STUDENT PROJECT: DEVELOPMENT OF IMMUNOHISTOCHEMICAL STAINING TECHNIQUES FOR PCNA AND APOPTOSIS TISSUE MARKERS ON RAT TISSUES IN THE CFSAN PATHOLOGY LABORATORY.
S./. Francke

A-19
Analysis of Potentially Pathogenic Phenotypes of Cell Membrane Microparticles in Apheresis Platelets.
M.P. Gelderman-Fuhrmann

A-20
A Subclinical Renal Injury Model in Rats for Detection of Nephrotoxic Compounds.
P.L. Goering

A-21
Development and Validation of a High Content Cell Based Assay Using Imaging Technologies for the Detection of Neutralizing Antibodies to a Therapeutic Protein in Human Serum.
S.-. Gupta

A-23
The utility of monitoring cardiac troponin T to detect cardiac injury induced by low doses of isoproterenol in rats.
E.H. Herman

A-24
Resolution of clofibrate efficacy and toxicity in rats using a combined LC/GC/MS metabolomics biomarker approach.
A.J. Higgins

A-25
Cdc42 as a potential therapeutic target for the reduction of cellular proliferation and migration as measured in MDA-MB-231 breast cancer cells.
D.S. Hirsch

A-26
How Biomarkers can Improve Clinical Drug Development?.
P.R. Jadhav

A-27
Vaccinia Immune Globulin Treatment in a Mouse Model of Progressive Vaccinia.
M.C. Kennedy

A-28
Characterization of a recombinant Interleukin-13 (IL-13) Receptor alpha 2 extracellular domain in blocking biological activities of IL-13.
M. Kioi

A-29
Metabolic health status by metabonomics.
S. Kochhar

A-30
Development of a multivariate statistical model for nephrotoxicity biomarker identification based on urinary 1H-NMR spectral pattern.
I. Schuppe Koistinen

A-31
Effects of Implantable Cardioverter-Defibrillator (ICD) Shocks upon Human Blood.
V. Krauthamer

A-32
A novel in vitro system for the evaluation of human drug adverse effects: The integrated discrete multiorgan co-culture (IdMOC) system.
A.P. LI

A-33
Testing biomaterials for stimulation of major inflammatory pathways.
D.B. Lyle

A-34
An In Vitro Test for Inflammatory Potential of Hyaluronic Acid Preparations.
D.B. Lyle

A-35
Age-related changes in intestinal crypt density may contribute to increased sensitivity of soy-fed female rats to acute toxicity of azoxymethane.
B. Magnuson

A-36
Effect of age on azoxymethane-induced colonic apoptosis in rats.
B. Magnuson

A-37
Quantitative morphometric analysis (QMA) of prion protein (PrPSc) for improved diagnosis of Transmissible Spongiform Encephalopathies (TSEs).
O.A. Maximova

A-38
In Silico Discovery of Bridging Renal Biomarkers.
D.L. Mendrick

A-39
Phenotyping Escherichia coli O157:H7.
A. Mukherjee

A-40
Candidate Cross-Species Biomarkers of Fibrosis and Hepatitis.
M.S. Orr

A-41
Elevated Circulating Endothelial Microparticles in Acute Stroke Patients: A Correlation with Brain Lesion Volume and Outcome.
J. Simak

A-42
Effects of the Anesthetic, Ketamine, in Developing Rat and Monkey Forebrain Cultures.
W. Slikker, Jr.

A-43
A REEVALUATION OF ANNEXIN I EXPRESSION IN NORMAL BREAST AND BREAST CARCINOMA.
R. Speer

A-44
Risk of Local Adverse Events Following Cardiac Catheterization by Hemostasis Device and Gender.
D.R. Tavris

A-45
Neuroimaging Studies in CNS Drugs Approved from 1995 to 2004.
R.S. Uppoor

A-46
Mechanistic studies of the photocytotoxicity elicited by tattoo inks and component pigments.
W.G. Wamer

A-47
Application of A Model-Based Analysis to Improve the Drug Development Plan for A Life-Threatening Disease.
Y. Wang

A-48
Expression of hypoxia inducible factor (HIF-1a), erythropoietin (EPO) and heme oxygenase in guinea pig (Cavia porcellus) after exchange transfusion with hemoglobin-based blood substitutes.
L. Yeh

A-49
Estimating the Uncertainty in the Estimated Mean Area Under the ROC Curve of a Multi-Feature Classifier.
W. Yousef

A-50
RhoGDI Protects Cancer Cells against Drug-induced Apoptosis.
B. Zhang

A-51
EXAMINATION OF THE VASCULAR INJURY IN SPRAGUE-DAWLEY (SD) RATS INDUCED BY THE PHOSPHODIESTERASE (PDE) IV INHIBITOR SCH 534385: A COMPARISION WITH SCH 351591.
J. Zhang

A-52
Bioinformatics Analysis of Possible Biomarkerfor the Evaluation of Biologics Product Quality.
B.G. Zaslavsky

B. PREDICTIVE TOXICOLOGY: TOXICOGENOMICS AND MODELING

B-01
An Analysis of Genetic Toxicity, Reproductive and Developmental Toxicity, and Carcinogenicity Data: I. Identification of Carcinogens Using Surrogate Endpoints.
R. Benz

B-02
An Analysis of Genetic Toxicity, Reproductive and Developmental Toxicity, and Carcinogenicity Data: II. Identification of Genotoxicants Using In Silico Methods.
R. Benz

B-03
Beyond the LFER Paradigm: Harnessing Atomic Descriptors and Artificial Neural Networks to Predict pKa.
R. Fraczkiewicz

B-04
Development of a Structure-Searchable Subchronic Studies Database for Use in Predictive Toxicology Modeling.
C.P. Nelson

B-05
Does the lack of genetic diversity in animal models currently used for safety testing put the public at risk?.
S.H. Nye

B-06
Comparison of Felbamate and Fluorofelbamate Intermediary Metabolism by Human Liver S9 Fractions Leading to Reactive Metabolites.
r.j. parker

B-07
The teratogen, valproic acid, alters homeobox gene expression during retinoic acid-induced nerve cell differentiation.
D.H. Reese

B-08
Metabonomics: Bringing Safety Assessment into Early Drug Discovery.
D.G. Robertson

B-09
The Prediction of Maximum Recommended Therapeutic Dose (MRTD) with a Neural Network Ensemble Model.
B. Steere

B-10
MONITORING TIME-DEPENDENT EMERGENCE OF DRUG TOXICITY: USE OF A SPREADSHEET PRESENTATION IN TOXICITY MANAGEMENT.
K. Wu

B-PO-11
Review Tool for Pharmacogenomcis Data Submission: ArrayTrack.
W. Tong

C. PREDICTIVE PHARMACOKINETICS AND PHARMACODYNAMICS

C-01
Plasma and/or Urine Penicillin Concentrations Predict Kidney Tissue Tolerance Level.
O.A. Chiesa

C-02
Dose-Dependent Transitions in Mechanisms of Toxicity.
N.G. Doerrer

C-03
Generic drug products demonstrate small differences in bioavailability relative to the brand name counterparts.
S.H. Haidar

C-04
The Prediction of Human Pharmacokinetics at the Therapeutic Dose from Low Sub-Therapeutic Doses in Human.
C.L. Holliman

C-05
Do Men and Women Differ in Proximal Small Intestinal CYP3A Or P-Glycoprotein Expression?.
S. Huang

C-06
Dose Dependent Inhibition of Midazolam Elimination by Ketoconazole: Effect of CYP3A5 Genotype.
S. Huang

C-07
SB-497115, a Novel, Oral, Small Molecule Thrombopoietin Receptor Agonist, Increases Platelet Counts in Healthy Subjects.
J.M. Jenkins

C-08
PREDICTION OF DRUG CLEARANCE FROM IN VITRO DATA FOR 11 DRUGS IN NEONATES, INFANTS AND CHILDREN USING SIMCYP.
T.N. Johnson

C-09
THE EFFICIENCY OF MIXED EFFECT MODELLING TO DETECT METABOLISM-BASED DRUG-DRUG INTERACTIONS (mDDI).
T.N. Johnson

C-10
Laboratory of Cardiovascular and Interventional Therapeutics: Program Overview.
J.W. Karanian

C-11
Blood flow and artery type are key determinants of endothelial cell gene expression and the development of vascular disease.
J.W. Karanian

C-12
Pharmacokinetics of Local Drug Delivery Depends on Mode of Delivery and Hemodynamics in an In Vitro Vascular Flow Model.
J.W. Karanian

C-13
Minimally Invasive Endoscopic Techniques Allow Serial Tissue Visualization and Sampling for Pharmacokinetics and Safety Studies in Large Animal Models of Vascular Disease and Intervention.
J.W. Karanian

C-14
Moderate Hyperlipidemia in Swine Results in Human-Like Restenosis Following Coronary Stenting.
J.W. Karanian

C-15
Safety and Effectiveness of Drugs to Treat Vascular Disease Depend on Mode of Delivery: Peri-Vascular Effects of Paclitaxel in Swine.
J.W. Karanian

C-16
Single and Multiple Dose Sparse Sampling PK/PD Modeling of Pregabalin Effect in Rat Capsaicin Induced Allodynia with Translation to Human Response.
J.R. Koup

C-17
Simulation of Absorption of Mesalamine from Delayed Release Tablets.
h. kwon

C-18
Development Of A Flow Through Dissolution Method For The Determination Of Metformin Hydrochloride And Comparison Of An In-house Versus Commercial Controlled Release Formulation Using GastroPLUS.
C.L. Li

C-19
PK/PD MODELING OF THE INTERACTION BETWEEN IV SCOPOLAMINE (SCP) AND PHYSOSTIGMINE (PHY) IN HEALTHY ELDERLY VOLUNTEERS.
A. Men

C-20
Exposure-response analyses lead to more informed regulatory decisions: The Oncology Drug Experience.
R.P. Ramchandani

C-21
The pharmacokinetics of TMC125 in different mouse strains: impact on carcinogenicity testing strategy.
A. Raoof

C-22
Pharmacokinetic-Probabilistic Simulations of Risk of Blood Pressure Changes Associated with the Cyclamate Metabolite Cyclohexylamine.
W.L. Roth

C-23
Simulation of the Influence of Formulation Factors and Dissolution Rates on the Absorption of Phenytoin Sodium In Vivo.
P.M. Sathe

C-24
Improving Pediatric Labels Through the Pediatric Initiatives, What We Have Learned.
A. Selen

C-25
Physicochemical profiling of food-effect for immediate-release formulations.
B.N. SINGH

C-26
Exposure-response analysis of the novel oral taxane BMS-275183 in patients with advanced solid tumors.
S. Song

C-27
Virtual Bioequivalence Trials Can Help Reduce Risk of Failure.
W.S. Woltosz

C-28
Incorporation of inter-individual variability into the prediction of in vivo drug clearance from in vitro data.
K. Rowland Yeo

C-29
Implications of the disparity in relative holo:apo-protein contents of different standards used for immuno-quantification of hepatic cytochrome P450 3A4 (CYP3A4).
K. Rowland Yeo

C-30
Inter-individual variability in the catalytic activity of CYP3A4 per unit of enzyme (kcat).
K. Rowland Yeo

C-31
Inter- and intra-individual variability in gastro-intestinal physiology has significant effects on the prediction of fraction of dose absorbed (fa).
K. Rowland Yeo

C-32
A critical evaluation of the experimental design in reports of mechanism based inhibition (MBI) studies and the assessment of their implication for in vitro-in vivo extrapolation.
K. Rowland Yeo

D. PHARMACOGENOMICS AND PROTEOMICS AS PRODUCT DEVELOPMENT TOOLS

D-01
EFFECTS OF DELAY IN TISSUE PROCESSING/FIXATION ON PROTEIN EXPRESSION PROFILES OF NORMAL AND MALIGNANT COLON TISSUE.
J.A. Aquino

D-02
Evaluation of a Genetically Modified Leishmania Parasite towards the Development of a Safe and Effective Vaccine.
R.C. Duncan

D-04
Changes in Protein Expression of Saccharomyces cerevisiae Cultured on Different Carbon Sources Determined With LCMS and Informatics Tools.
B. Kenney

D-05
Reverse Protein Microarray Analysis of Lymphangiogenesis.
L.V. Leak

D-06
CHOLESTERYL ESTER TRANSFER PROTEIN VARIANTS HAVE DIFFERENTIAL STABILITY BUT UNIFORM INHIBITION BY TORCETRAPIB.
D.B. Lloyd

D-07
Mapping of Genes That Affect the Antibody Response to Human Factor VIII and IX in Mice.
J.N. Lozier

D-08
Analysis of single nucleotide polymorphisms (SNPs) using microarrays.
R.K. Panguluri

D-09
Pharmacogenomic Data Submissions: Impact on FDA’s Submissions and Review Process.
A. Rudman

D-10
Cross-platform Comparability of Microarray Technology: Intra-platform Consistency and Appropriate Data Analysis Procedures Are Essential.
L. Shi

D-11
The MAQC (Microarray Quality Control) Project: Calibrated RNA Samples, Reference Datasets, and QC Metrics and Thresholds.
L. Shi

D-12
Microarray Scanner Calibration Curves: Characteristics and Implications.
L. Shi

D-13
Molecular Characterization of a Hemophilia A Dog Model.
N. Tayebi

D-14
APPLICATION OF A CROSS-PLATFORM RNA STANDARD FOR ASSESSING MICROARRAY DATA COMPARABILITY.
K.L. Thompson

D-15
Influence of the UGT1A1*28 and UGT2B7*2 genetic polymorphisms on enzyme activities: How can we be confident that we are not missing functionally relevant polymorphisms in other enzymes and transporters?.
J. Williams

E. INNOVATIVE APPROACHES TO DESIGN AND EVALUATION OF CLINICAL TRIALS

E-01
Assessing Treatment Differences Using a Weighted Responder Analysis.
L. Chen

E-02
FDA's critical path initiative for evaluation of devices for the correction of presbyopia.
B.A. Drum

E-03
Estimation of Treatment Effect in the Presence of Non-compliance: A Simulation Study.
Y. Gao

E-04
Statistical Considerations for Non-inferiority Trial Methodology in Regulatory Applications.
H. Hung

E-05
Novel confocal laser method for intraocular lens power testing: How a laboratory born invention goes through the path from bench to independent clinical sample testing.
I.K. Ilev

E-06
Model-based longitudinal data analysis can lead to more efficient drug development: A Case Study.
P.R. Jadhav

E-07
Time to Perceptible and Meaningful Pain Relief.
M. Katzper

E-08
HIV-1 infections during vaccine trials: Identifying new peptides for differential diagnosis of HIV-1 infections in the face of vaccine-generated antibodies.
S. Khurana

E-09
Issues of concern when applying the most popular statistical methods of survival analysis to medical device studies.
B. Krasnicka

E-10
Statistical Consideration of Group Sequential Method for Bioequivalence Assessment.
H. Li

E-11
A Retrospective Approach for Analyzing the Data Collected from the Adverse Events Reporting System.
P.T. Liu

E-12
Patient Reported Outcomes: Comparison of Two Simulated Treatment Groups in which Extreme Values of Ordinal Responses are Under-Reported.
T.J. Massie

E-13
Noninferiority Hypothesis with Binary Endpoints.
T. Ng

E-14
A New Graphic Tool for Reviewers to Evaluate Studies for Drug-Induced Liver Injury (DILI).
J.R. Senior, M.D.

E-15
Power of Simultaneous Test of superiority and Non-inferiority Using Cross-Trial Comparison Approach – A Simulation Study.
Y. Tsong

E-16
“Responder analysis” of clinical relevant evidence of trials.
Y. Tsong

E-17
Non-inferiority Cardiovascular Device Trial Design with Adaptive Delta to Underlying Control Rate.
Y. Xu

E-18
The Application of Propensity Score Analysis to Non-randomized Medical Device Clinical Studies: Regulatory Considerations.
L. Yue

E-PO-19
New tests for assessing equivalence and non-inferiority from survival data: An intuitive approach.
K.M. Koti

F. PROCESS ANALYTICAL TECHNOLOGY (PAT) AND PHARMACEUTICAL TECHNOLOGY

F-01
Quantitative Process Characterization – An Essential Step of a Robust PAT Program.
P. Cini

F-02
A Risk Managed Approach for Implementation of Spectroscopic Techniques in Powder Blend Monitoring.
A. El Hagrasy

F-03
Applying Process Analytical Technology to Improve Efficiency and Reliability of Spray Coating.
A. El Hagrasy

F-04
Process Understanding: Relating Scanning Electron Microscopy Studies of Powder Blends with Capsule Dissolution Performance.
C.D. Ellison

F-05
Monitoring magnesium stearate coating of particles by Near-Infrared (NIR) chemical imaging.
C.D. Ellison

F-06
Process Analytical Technology (PAT) Tools: Chemometric Evaluation of Furosemide Tablet Formulations.
C.D. Ellison

F-07
Preprocessing Method Selection Strategies for Chemometric NIR Spectral Analysis.
R.M. Fahmy

F-08
Influence of manufacturing changes and formulation excipients on the direct determination of furosemide in solid oral dosage forms using laser-induced breakdown spectroscopy (LIBS).
P.J. Faustino

F-09
Impact of Sodium Butyrate Supplementation on Global Gene Expression and Monoclonal Antibody Glycosylation Patterns in Murine Hybridoma Cells.
M.A. Hanson

F-10
A Comparative Study of Single and Group Assay of Solid Pharmaceutical Dosage Forms to Determine the Potential Sources of Variability Using Near-Infrared Spectroscopy and Chemometric Models.
S. Hassannejad Tabasi

F-11
Synergistic antitumor activity of temozolomide and IL13-Pseudomans exotoxin against human glioblastoma in a mouse model.
S.R. Husain

F-12
Process Analytical Technology (PAT) Tools: Determining Content of Acetaminophen Tablets (APAP) by Attenuated Total Reflectance (ATR) FT-IR Spectroscopy and FT-Raman Spectroscopy.
E.H. Jefferson

F-13
Vibrational Spectroscopy of Coated Tablets.
J.F. Kauffman

F-14
Preparation of Various Insulin Crystals for Long-Acting Insulin Formulation.
J.F. Liang

F-15
Practical Aspects on using Multivariate Data Analysis for PAT Implementations: Issues of Software Validation and Method Development.
S. Lo

F-16
Process Analytical Technology: FDA Research Activities.
R.C. Lyon

F-17
Monitoring Drug Product Stability by Near-Infrared Chemical Imaging.
R.C. Lyon

F-18
Rapid Development of a Fragmented Antigen Binding (Fab) Antibody Production Process using Retentate Chromatography - Surface Enhanced Laser Desorption/Ionization - Mass Spectrometry (RC-SELDI-MS).
J.T. Park

F-19
Development of Quantitative In-Process Control Affinity HPLC Assays for Production of Four Different Classes of Antibodies: IgG, IgM, IgY, and Fab.
J.T. Park

F-20
Application of Process Analytical Technology (PAT) To a Commercial Solid Oral Dosage Form.
d.n. shah

F-21
Tablet Content using Terahertz Transmission Spectrometry.
J.A. Spencer

F-22
An Integrated Modeling Approach for Studying Coated Tablet Dissolution Process.
H. Wu

F-23
The segregation propensity of formulations with different drug to excipient particle size ratios in capsule filling performance.
L. xie

F-24
Preclinical Development of Folate Liposomal Doxorubicin.
X.B. Zhao

G. MEDICAL PRODUCT DESIGN, CHARACTERIZATION, AND MANUFACTURING

G-01
Novel Nanopore Structured Glucose Biosensors Promote Reagentless Glucose Concentration Measurements in the Hypoglycemic Range.
e.t. chen

G-02
Reducing Risk with Medical Devices Used in the Home.
A.A. Ciarkowski

G-03
Unexpected Genetic Alterations Occur in Nontargeted Regions During the Construction of Viral Vectors.
M.J. Dambach

G-04
Shielding Small-Field High-Energy Electron Beams in Cancer Treatment.
M. Farahani

G-05
Development of a FACS based potency assay for immuno-modulatory therapeutics using phospho-specific antibodies.
L.J. Graham

G-06
Carotid Stenting: Real-World Experience during the First Six Months of Marketing.
A.D. Holton

G-07
Application of Nanocapsules in Drug Delivery.
Y. Hsieh

G-08
A natural anticancer plant drug, b-elemene, sensitizes resistant ovarian carcinoma cells to cisplatin-induced apoptosis.
Q.Q. Li

G-09
Beta-elemene, a novel plant antineoplastic agent, enhances chemosensitivity of lung cancer cells through triggering apoptosis.
Q.Q. Li

G-10
In vitro combination characterization of beta-elemene with taxanes against human lung cancers.
Q.Q. Li

G-11
Sequence-dependent effect of beta-elemene on 5-fluorouracil-induced cytotoxicity in cyclooxygenase-2-expressing colon cancer cells.
Q.Q. Li

G-12
EVALUATING SELF-MICROEMULSIFYING DRUG DELIVERY SYSTEM (SMEDDS) FOR POORLY WATER-SOLUBLE DRUGS (I):THE OIL EFFECT ON SOLUBILIZING FLURBIPROFEN BY OIL-IN-WATER MICROEMULSIONS.
P. Li

G-13
EVALUATION OF X-RAY IRRADIATED PNEUMOCOCCAL 7-VALENT CONJUGATES AND POLYVALENT PNEUMOCOCCAL VACCINE POLYSACCHARIDES AND X-RAY and GAMMA RAY IRRADIATED ACELLULAR PERTUSSIS COMPONENT OF DTaP VACCINE PRODUCTS.
J.C. May

G-14
Breakage of Blood Bags Used Off-Label to Store Hematopoietic Stem Cells.
M.K. McDermott

G-15
Fabrication Variability and Consistency of Controlled Release Technologies.
M.K. McDermott

G-16
Characterization of the Structure and Properties of Authentic and “Suspect Counterfeit” Polypropylene Surgical Meshes.
M.K. McDermott

G-18
Observations on the Morphology and Growth of Microvacuoles in Foldable Intraocular Lenses.
D. Richardson

G-19
In Vitro Clustering of Microvacuoles in Foldable Intraocular Lenses.
D. Richardson

G-20
Improving drug infusion safety with a microfluidic sensor.
D.R. Sparks

G-21
EFFECT OF CYCLODEXTRINS ON THE PERMEABILITY OF MODEL DRUGS THROUGH CACO-2 CELL MONOLAYERS.
D.A. Volpe

G-22
EFFECT OF TEMPERATURE AND pH STRESS ON LIPOSOME CYTOTOXIC ACTIVITY.
D.A. Volpe

G-23
CpG independent synergistic induction of beta-chemokines and a dendritic cell phenotype by orthophosphorothioate oligodeoxynucleotides and GM-CSF in elutriated human primary monocytes.
J. Wang

G-25
In-vitro test method development for determining Transdermal Drug Delivery Systems (TDDS) adhesion.
A.M. Wokovich

G-PO-24
Characterization of differences in isoelectric focusing behavior of plasma-derived alpha-1-proteinase inhibitor products.
E. Marszal

H. RISK MANAGEMENT, RISK ASSESSMENT, AND RISK COMMUNICATION FOR DRUGS AND FOOD

H-01
Impact of correction formulae on the QTc interval with a drug suspected to prolong the QT interval.
C.R. Bonapace

H-02
Intra-island horizontal exchange drives genetic diversity within the SPI-1 pathogenicity gene cluster of group I Salmonella pathogens.
E.W. Brown

H-03
Use of Standards-Based Data and Tools to Improve the Efficiency of the NDA Safety Review.
C.K. Cooper

H-04
Modeling the Interaction of the Physiological State of the Inoculum and CO2 Atmosphere on the Lag Phase and Growth of L. monocytogenes.
A.J. De Jesús

H-05
The Most Common FDA-Regulated Foods Linked to Foodborne Illness Outbreaks, 1990-2003.
C. Smith DeWaal

H-06
Prevalence and Antimicrobial Susceptibility of Campylobacter Isolated from Retail Meat and Poultry in the United States, NARMS 2003.
L.L. English

H-07
Identifying Public Food Safety Information by analyzing the contacts with the Food Information Center (FIC).
A. Fooladi Moghaddam

H-08
Drug Interaction Studies -- Study Design, Data Analysis, and Implications for Dosing and Labeling: Current Opinion.
S. Huang

H-09
Stability screening of in vitro stock drug solutions.
R.L. Hunt

H-10
Quality review of congenital anomaly reports sent to the FDA.
D.L. Kennedy

H-11
Testing for Hypersensitivity Reactions to Intravenous Drug and Biologic Agents: Recommendations in Product Labels.
H. Ko

H-12
Mechanistic Information & Regulatory Decisions.
S. Kozlowski

H-13
Trends in Use of Clotrimazole/Betamethasone Dipropionate combination products in pediatric patients.
L.A. La Grenade

H-14
Development and Use of the Aquaculture Risk Information System (AQRIS) and Risk Ranking Tool (AQRRT) for Prioritizing Import Sampling and Other Activities.
J.P. Laurenson

H-15
Communication of Drug Risk Information to Pharmacists.
L.Y. Lee

H-16
A National Survey of Pharmacists to Assess Drug Risk Communication Tools for Patients.
L.Y. Lee

H-17
Acute renal failure in patients using sodium phosphate tablets as bowel preparations.
A.C. Mackey

H-18
Genetic homogeneity and evolutionary discordance implicate horizontal gene transfer in the evolution of the polA active site in Salmonella enterica.
T.J. Mays

H-19
A New Face on an Old Problem: Excipient Exposure in the Neonatal Intensive Care Unit.
S. McCune

H-20
The Food Safety Risk Analysis Clearinghouse: Practical Uses in Risk Analysis.
C.F. McLaughlin

H-21
EVALUATING THE TERATOGENIC POTENTIAL OF ANTIBIOTICS IN PREGNANT WOMEN.
G.G. Nahum

H-22
The Annual Health Cost of Food-Related Illness.
C. Nardinelli

H-23
Effect of ambient temperature/atmospheric pressure ammoniation of aflatoxin-contaminated dairy ration cottonseed on the levels of aflatoxin M1 in milk.
H. Njapau

H-24
Evidence for type I restriction-modification as a porter for extensive recombination among closely related Salmonella strains.
A. Perlloni

H-25
Effects of Androstenedione on Total Free Fatty Acids in Pregnant Rats.
I.A. Ross

H-26
Hearing Loss in Patients Treated with Itraconazole Standard and Pulse Therapy: A Review of FDA’s Adverse Event Reporting System (AERS).
A.M. Rothstein

H-27
Foodborne Outbreaks and Latinos: 1973-2004 A Retrospective.
L.A. Solorzano

H-28
Minimizing hypoglycemia attributed to an interaction between icodextrin peritoneal dialysis solution and blood glucose test strips: Utility of a U.S. postmarketing safety program.
M. Southworth

H-29
Radiation Safety in Medicine: Radiation Dose and Risk Assessment.
O.H. Suleiman

H-30
Lactic Acidosis: Unraveling the Individual Toxicities of Drugs Used in HIV and Diabetes Polytherapy by Hierarchical Bayesian Logistic Regression Data Mining.
A. Szarfman

H-31
PROJECTING THE NUMBER OF EXCESSIVE ADVERSE EVENTS DUE TO A TREATMENT.
Y. Tsong

H-33
Consumer Reactions to Modifications of Allergen Information on the Food Label: Focus Group Results.
L.A. Verrill, Ph.D.

H-34
POST-LICENSURE SAFETY SURVEILLANCE FOR RECOMBINANT HUMAN COAGULATION FACTOR VIIa.
J.J. Wood

H-PO-35
UV Doses Worldwide.
D.E. Godar

H-PO-36
A Melanoma Hypothesis: The Paradox of Outdoor and Indoor Solar UV Exposures.
D.E. Godar

H-PO-37
Post-Marketing Reports of Serotonin Syndrome Associated With Linezolid.
A. Sorbello

I. ANALYTICAL CHEMISTRY: METHODS DEVELOPMENT AND APPLICATIONS

I-01
LC-Visible Analysis of Malachite Green and Leucomalachite Green (LMG) Residues in Salmon, Catfish, and Trout with In-Situ LMG Oxidation.
W.C. Andersen

I-02
Multiclass Confirmation of Veterinary Drug Residues in Fish by Liquid Chromatography-Ion Trap Mass Spectrometry.
M.C. Carson

I-03
Probing Alterations of the Mitochondrial Membrane Proteome in a Murine Model of Parkinson’s Disease using Liquid Chromatography-Tandem Mass Spectrometry.
D.R. Cawthon

I-04
Liquid Chromatography/Tandem Mass Spectrometry for the Determination of Bound Residues of Nitrofurans in Channel Catfish.
P. CHU

I-05
Development of a high-performance liquid chromatography (HPLC) stability-indicating method for gabapentin.
A.B. Ciavarella

I-06
Detection of Penicillin Residues on Environmental Swabs by Liquid Chromatography and Mass Spectrometry.
S.B. Clark

I-07
Analysis of Penicillin Residues on Environmental Swabs by Liquid Chromatography and Mass Spectrometry.
S.B. Clark

I-08
Analysis of Ginkgo Marker Compounds in “Functional Food” Products.
L.S. deJager

I-09
Monitoring Deaeration of Aqueous Media for Dissolution Testing by Total Dissolved Gas Pressure Meter.
Z. Gao

I-10
Evaluation of Commercial ELISA Assays for the Detection of Egg in Food.
E.A. Garber

I-11
Evaluation of Commercial ELISA Kits for Wheat Allergens.
V. Brewer

I-12
Evaluation of Commercially Available ELISA-Based Kits for Wheat Allergen Analysis in Malt Beverages.
J.R. Ammann

I-13
Evaluation of Actuation Parameters That Affect Nasal Spray Characteristics.
C. Guo

I-14
NMR Spectroscopy in Herbal Drugs and Dietary Supplements.
G.M. Hanna

I-15
Analysis of Consumer Cosmetic Products for Phthalate Esters.
D.C. Havery

I-16
Testing the Test Kits: An LC/MS/MS method for penicillin in positive control milk.
D.N. Heller

I-17
Cold Vapor Atomic Absorption Determination of Mercury in D&C Black No. 2 (High Purity Furnace Black).
N.M. Hepp

I-18
Highly Optimized strategy for expression and purification of two biologically active tumor specific cytotoxins consisting of human interleukin-13 and Pseudomonas exotoxin in Escherichia coli.
B.H. Joshi

I-19
Determination of Sildenafil in Tablets by Liquid Chromatography with Tandem Mass Spectrometry Detection Method.
C.M. Karbiwnyk

I-20
Confirmation of Oxolinic Acid and Flumequine Residues in Shrimp by Liquid Chromatography with Tandem Mass Spectrometry Detection.
C.M. Karbiwnyk

I-21
Quantification and Activity of Human Alpha-1-Proteinase Inhibitor in Complex Biological Mixtures: Assay Development.
E. KARNAUKHOVA

I-22
Recombinant Glycosylated Human Alpha-1-Proteinase Inhibitor Expression in a Filamentous Fungus, Aspergillus niger.
E. KARNAUKHOVA

I-23
Lead in Pharmaceutical Dosage Forms.
J.F. Kauffman

I-24
Microarray Detection of Multiple Antibiotic Resistance Markers by the Use of RNA Obtained by a Commercial Kit and Triton X-100 Boiling Method.
S.A. Khan

I-25
Determination and Confirmation of 17alpha-Methyltestosterone in Rainbow Trout.
M.I. Lopez

I-26
Release of the plasticizer di-2-ethylhexyl phthalate (DEHP) into normal saline stored in heated and nonheated PVC bags.
A.D. Lucas

I-27
Bleach Tampering Investigation of Two Fruit Flavored Beverages.
S.E. McMullen

I-28
Are Homogenizers Extinct?.
S.E. McMullen

I-29
Dissolution Testing of Mesalamine Delayed Release Tablets.
T.W. Moore

I-30
Separation and Quantitation of Arsenic Species in Food and Dietary Supplements by HPLC-ICP-MS.
S. Nam

I-31
The Determination of Semicarbazide (N-aminourea) in Commercial Bread Products.
g.o. noonan

I-32
Determination of Furan in Foods.
P.J. Nyman

I-33
Separation and Identification of Pigments found in Permanent Cosmetic/Tattoo Inks using Reversed-phase High Performance Liquid Chromatography and Photodiode Array Detection.
B.R. Petigara

I-34
Isolation and Quantification of Sudan I in Worcestershire Sauce.
B.R. Petigara

I-35
A New Technique for Protein Purification - Centrifugal Precipitation Chromatography.
L. Qi

I-36
Idiosyncrasies of a Porous Graphitic Carbon Stationary Phase During Analysis of Conjugated Estrogens by Liquid Chromatography-Mass Spectrometry.
J.C. Reepmeyer

I-37
Analysis of the nitrogen mustard mechlorethamine in compounded topical pharmaceutical preparations by high performance liquid chromatography.
J.C. Reepmeyer

I-38
Drug Substance Stability in Liposomal Drug Products (LDPs) under Various Stress Conditions.
l.k. revelle

I-39
Monitoring Lipid degradation in Liposomal Drug Products (LDPs) using HPLC with Evaporative Light Scattering Detection (ELS).
l.k. revelle

I-40
Assessment of Encapsulation Efficiency Stability of Liposomal Drug Products (LDPs) under Various Stress Conditions.
l.k. revelle

I-41
Multi-Laboratory Evaluation of the QuEChERS Method for Pesticide Residue Analysis.
F.J. Schenck

I-42
Oligonucleotide microarray based detection of bacterial pathogens relevant to food and reused medical devices.
N.V. Sergeev

I-43
Comparison of whole genome amplification strategies for microarray-based analysis of bacterial pathogens.
N.V. Sergeev

I-44
Development of a Simple Stability Indicating HPLC Method for Ranitidine Hydrochloride.
R.B. Shah

I-45
Determination of albendazole and its metabolites in catfish after oral administration.
B. Shaikh

I-46
HPTLC analysis of blue cohosh for alkaloids.
S.-. Subramaniam

I-47
Differences in the constituents of two subspecies of Teucrium, Teucrium chamaedrys L. and T.canadense determined by analytical reversed-phase method.
P.R. Sundaresan

I-48
Determination of Mycotoxins in Botanical Roots.
M.W. Trucksess

I-49
Confirmation of Diminazene Diaceturate (Berenil) in Bovine Milk by LC-MS.
S. Turnipseed

I-50
Analysis of Protective Antigen in Final Product of Human Anthrax Vaccine.
H. Wang

I-51
Determination of Niacin and Biotin Using Microwell Microbiological Assays.
G.M. Ware

I-52
The Use of Electrodialysis to Prepare Aqueous Bread Extracts for Bromate Determination by Chemiluminescence.
C.R. Warner

I-53
High-Performance Liquid Chromatographic Method for the Determination of Triiodoresorcinol in the Color Additive FD&C Red No. 3 (Erythrosine).
A. Weisz

I-55
Simultaneous Determination of Protein Aggregation and Stability as well as Absolute Molecular Weight by SEC-MALLS.
H. Ye

I-56
Patulin Analysis Using A MycoSep Column.
M.B. Young

I-57
Synthesis and prophylactic antimalarial activities of 2-guanidinylimidazolidinedione derivatives.
Q. Zhang

I-62
Identification of Metals and Other Elements in Tattoo Inks by X-Ray Fluorescence Spectrometry.
N.M. Hepp

I-PO-58
HPLC Determination of Novobiocin in Dosage Forms.
L.P. Lue

I-PO-59
Development of Method for the Measurement of Tissue Steroids in Pregnant Rats.
I.A. Ross

I-PO-60
A Cost Saving Approach to the HPLC-Postcolumn Derivatization Analysis of 35 N-Methylcarbamate Pesticide Residues in Fruits and Vegetables.
F.J. Schenck

I-PO-61
Melatonin Analysis in Dietary Supplements by HPLC using UV-VIS detector.
J.o. Vega

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

J-01
Immunogenicity of West Nile Virus-like Particles in Mice.
J.E. Adamo

J-02
Molecular Identification of Yersinia enterocolitica Using DNA Microarray Chip Hybridization.
S.F. Alkhaldi

J-03
Lowering the Detection Limits of HIV-1 Viral Load Using Real-time Immuno-PCR (IPCR) for HIV-1 p24 Antigen.
J. Barletta, Ph.D.

J-04
Immune Complex Repression of Interferon-gamma Signaling by a Novel Fc-gamma-Receptor-1 Function.
G.H. Boekhoudt

J-05
Development of a Quantitative Multiplex RT-PCR Assay for the Detection of Noro- and Enteroviruses.
W. Burkhardt

J-06
Identification of a new drug target for treatment of human leishmaniasis.
A. Debrabant

J-07
The Effects of Agricultural Pesticide and Antibiotic Applications on Apples and Apple Juice Microflora.
B.S. Eblen

J-08
Steroid Hormones are Substrates for the Major RND- and MFS-type Tripartite Multiple Drug Efflux Pumps of Escherichia coli.
C.A. Elkins

J-09
Assessment of Dermal Absorption, Metabolism, and Irritation Potential of Arachidonic Acid & Glyceryl Arachidonate Using In Vitro Diffusion Cell Techniques.
A.R. Eppler

J-10
Synergistic inhibition of rat liver cytochrome P450 (CYP) activities by co-exposure to a bacterial (lipopolysaccharide) and mold (deoxynivalenol) toxin.
T.J. Flynn

J-11
Mechanistic studies on the photocytotoxicity of 2,3-diaminophenazine.
P.K. Fu

J-12
In Vitro Dermal Absorption and Metabolism of D&C Red No. 17.
C.T. Haynes

J-13
The evaluation of the role of A27L protein in vaccinia induced protective immunity.
y. he

J-14
Multiplex Real-Time PCR to Simultaneously Detect Listeria spp. and L. monocytogenes from a Variety of Food Enrichments.
A.D. Hitchins

J-15
Atypical Non-hemolytic Listeria seeligeri Isolated in the USA.
A.D. Hitchins

J-16
Bile Salts Tolerance of Clinical and Food Isolates of Listeria monocytogenes.
A.D. Hitchins

J-17
A simplified and efficient method for full-length cDNA Preparation.
Y. Hu

J-18
Antibiotic Resistance of Salmonellae Isolated from Various Products, 2003-2004.
C.R. Kiessling

J-19
Absorption of Lawsone through Human Skin.
M. Kraeling

J-20
Methyleugenol Skin Absorption in Human and Fuzzy Rat Skin.
M. Kraeling

J-21
Study of the Effect of Different Vaccination Schedules on Excretion and Reversion of Vaccine Poliovirus.
M. Laassri

J-22
Residual total protein levels on reprocessed gastrointestinal (GI) biopsy forceps.
s.k. lappalainen

J-23
Cytotoxicity of residual cleaning agents used in reprocessing medical devices.
s.k. lappalainen

J-24
TRANSPLACENTAL AND POSTNATAL EXPOSURE TO AIDS DRUGS ZIDOVUDINE (AZT) AND LAMIVUDINE (3TC) IN C3B6F1trp53(+/-) TRANSGENIC MICE.
J.E. Leakey

J-25
Characterization of amino acid substitutions associated with the neuroattenuation of a mumps virus.
T.H. Malik

J-26
Caspase-12 expression increases prior to induction of apoptosis during HAV 18f infection in FrhK4 cells.
D.T. Ngo

J-27
Comparison of Viral Extraction Protocols by qRT-PCR for Enumeration of Calicivirus in Shellfish.
J. Nordstrom

J-28
A conventional multiplex PCR application for the detection and speciation of Microsporidia in clinical specimens.
P.A. Orlandi

J-29
Immunological Response to MaPE of Mycobacterium avium 104.
M. Parra

J-30
Characterizing the mutator phenotype by global gene expression profiling of MMR-defective Salmonella enterica and Escherichia coli O157: H7.
I.R. Patel

J-31
CpG ODN enhance survival of pregnant mice to infection with Herpes Simplex type 2 virus during late-stage-pregnancy.
J.A. Pedras-Vasconcelos

J-32
Ingestion of Staphylococcal Enterotoxin B (SEB) in the Diabetic Mouse.
m. principato

J-33
Genetic Variability in West Nile Virus (WNV) Isolates From Blood Donors Specimens From 2002, 2003 and 2004 USA Epidemics.
M. Rios

J-34
Monocytes/Macrophages are a Potential Target in Human Infection with West Nile Virus (WNV) through Blood Transfusion.
M. Rios

J-35
Acute Histopathology and Total Blood Parameters in Young Male Rats Given Bacterial (Lipopolysaccharide-LPS) or Fungal (Deoxynivalenol-DON)Toxins.
M.G. Robl

J-36
In Vivo Studies on the Toxicity of Adenovirus Vectors for Kupffer Cells.
j.s. smith

J-37
Development of Selective Media for Detection Enterobacter sakazakii by Using Ferrioxamine E and alpha-glucosidase Substrates.
K. Song

J-38
A universal DNA microarray for detection of gene sequence changes---Applications to the detection of Mycobacterium tuberculosis (MTB) mutant genes associated with antibiotic drug-resistance and of pathogens contaminating medical devices.
X. Tang

J-39
Optimization of Ferrioxamine E Concentration as Effective Supplementation for Selective Isolation of Salmonella Enteritidis in Egg White.
G. Thammasuvimol

J-40
Moulds, yeasts and aerobic plate counts in ginseng supplements.
V. Tournas

J-41
USEFULNESS OF STUDIES ON THE MOLECULAR MECHANISM OF ACTION OF HERBALS/BOTANICALS: THE CASE OF ST. JOHN’S WORT.
L.G. Valerio Jr.

J-42
EVALUATION OF FLOW CTYOMETRIC ENDPOINTS FOR THE LYMPH NODE PROLIFERATION ASSAY (LNPA).
J.L. Weaver

J-43
Mutagenicity of chromium picolinate and its components in Salmonella typhimurium and L5178Y mouse lymphoma cells.
P. Whittaker

J-44
Evaluating the Risk of Transmission of Porcine Endogenous Retroviruses in Xenotransplantation Products.
C.A. Wilson

J-46
Bioeffects of ultrasound and ultrasound microcontrast agent on three mammalian cell lines.
S. Wood

J-47
Mechanistic insights into stent-mediated thrombosis and adverse events by stent-delivered drugs sirolimus and taxol.
S. Wood

J-48
Characterization of Salmonella Typhimurium of Animal Origin Obtained from the National Antimicrobial Resistance Monitoring System (NARMS).
s. zhao

J-58
Methods for Evaluation of the Immunotoxicological Responses to Nanoparticles in Mice.
V.J. Tomazic-Jezic

J-PO-49
Rubella Virus and Birth Defects: Molecular Insights into the Viral Teratogenesis at the Cellular Level.
C.D. Atreya

J-PO-50
UVA1-Mediated Receptor and Cytokine Changes of Transformed Lymphocytes.
D.E. Godar

J-PO-51
Comparative Kinetics of Invasion into Human Intestinal INT407 Cells by Different Intestinal Bacterial Pathogens.
L. Hu

J-PO-52
Rapid DNA Preparation for Real-Time PCR Detection.
D.K. Lau

J-PO-53
Detection of Salmonella Enteritidis in Incubated Pools of Shell Eggs Supplemented with Ferrioxamine E by Lateral Flow Test Kit.
K. Seo

J-PO-54
The Evaluation of Ferrioxamine E as a Selective Iron Source for Enterobacter sakazakii in iron Limited Nutrient Media and Egg White.
K. Song

J-PO-55
The Rapid Detection of Salmonella Enteritidis by Quantum Dot Biolabeling Coupled with Immunomagnetic Separation.
K. Song

J-PO-56
Persistence of Yersinia pestis in Bottled Water.
S.D. Torosian

J-PO-57
Detection of Yersinia pestis in Selective Enrichment of Certain Foods by Multiplex PCR.
S.D. Torosian

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

K-01
Elimination of alpha-Gal Alone From Source Pigs is Not Sufficient to Avoid NK Cell-Mediated Destruction of Porcine Endothelial Cells.
J.A. Arcidiacono

K-02
Characterization of differentiated stem cells on the basis of their gene expression profile.
B. Bhattacharya

K-03
Use of Methacrylated Beta-Cyclodextrin in Dental Restorative Fillings.
L.A. Hussain

K-04
Development of a Focused Microarray to Assess Stem Cell Differentiation.
A.X. Yang

K-05
Diminished Neural Signaling in Psammomys Obesus (Fat Sand Rat): Possible Predictor for Diabetes.
C. Zimliki

L. ENGINEERING AND PHYSICS

L-01
Radial efficiency function in refractive surgery: Ablation losses caused by corneal curvature.
B.A. Drum

L-02
Nanoshells Enhance Optical Coherence Tomography Images of Tissue Phantoms.
S. Huang

L-03
Continuous-wave vs. ultrashort (pico- and femtosecond) pulsed laser beam propagation through turbid tissue in minimally invasive laser medical devices.
I.K. Ilev

L-04
Designing and building a laboratory based high-resolution, high-frame-rate imaging system with extended dynamic range for cone-beam computed tomography and dynamic imaging applications.
I.S. Kyprianou

L-05
Quantum Yield Measurements of Drugs with the Potential to Interfere with Fluorescence-Based Diagnostic Devices.
S. Matchette

L-06
Electromagnetic Compatibility (EMC) of Active Medical Devices exposed to Wireless Personal Digital Assistants (PDAs).
G.G. Mendoza

L-07
Accidental Disconnection of Luer Locks.
M.R. Schwerin

L-08
Development of High Speed Nano-scale PCR for Detection and Identification of FDA Relevant Pathogens.
N.V. Sergeev

L-09
Development of miniature Point-of-Care microfluidic biosensor for simultaneous rapid detection of multiple microbial toxins.
N.V. Sergeev

M. NUTRITION AND OBESITY

M-01
A global perspective of vitamin D Intake.
M.S. Calvo

M-02
Dietary recommendations for vitamin D: critical need for functional endpoints to establish an estimated average requirement(EAR).
M.S. Calvo

M-03
Vitamin D Fortification of Food in North America: Current Status.
M.S. Calvo

M-04
Racial differences in vitamin D intake, dietary supplement use and vitamin D status among black and white men and women in the NHANES III survey.
M.S. Calvo

M-05
Physical Activity and Diet Predict Type II Diabetes Risk in the Diabetes Prone Sand Rat (Psammomys obesus).
A.A. Cotterell

M-06
Impact of Dietary Food Label Use on Nutrient Intakes.
A.I. Jessup

M-07
REDUCTION OF OBESITY IS ASSOCIATED WITH INCREASED HEPATIC CYP3A EXPRESSION IN WOMEN.
J.E. Leakey

N. COUNTERTERRORISM AND FOOD SAFETY

N-02
Accumulation of saxitoxins in the non-toxic northern puffer fish (Sphoeroides maculatus) from a food chain source.
J. Deeds

N-03
Prior exposure to an acidic environment increases the acid resistance of Enterobacter sakazakii.
S.G. Edelson-Mammel

N-04
Faster Speeds and Higher Success Rates: The Impacts of Improved Record-keeping Practices on Trace-back Performance.
A.J. Estrin

N-05
The receptor binding assay for tetrodotoxin and the saxitoxins: Progress toward the implementation of a sensitive, high throughput detection method for food defense and marine biotoxin management.
S. Etheridge

N-06
Quantitative determination of cesium binding to Prussian Blue: A treatment for internal radioactive metal contamination.
P.J. Faustino

N-07
The utility of immunomagnetic adsorption and FTA filter PCR for the screening of Cryptosporidium species in foods.
C.D. Frazar

N-08
New Cytokine Markers for the Activity of Anthrax Lethal Toxin.
D.M. Frucht

N-09
The Use of Near-Infrared Chemical Imaging (NIR-CI) for the Indentification of Micro-organisms of Concern in Food.
F.S. Fry

N-10
Effects of Food Matrices and Processing on Detection of the B Subunit of Ricin Using Enzyme-Linked Immunosorbent Assays.
G.M. Orlowski

N-11
Detection Of Ricin In Food Matrices Using Electrochemiluminescence (ECL)-based Technology.
E.A. Garber

N-12
Rapid Detection of Enterotoxigenic Escherichia coli - a Primary Agent of Infectious Diarrhea.
M.A. Grant

N-13
Effect of Sample Preparation and Preenrichment Media on the Recovery of Salmonella from Cantaloupes, Mangoes, and Tomatoes.
T. Hammack

N-14
Isolation of Yersinia pestis from Food using Immunomagnetic Capture.
D.E. Hanes

N-15
Comparison of Multi-Locus Sequence Typing, Pulsed Field Gel Electrophoresis, and Antibiotic Susceptibility Profiles for Characterization of Salmonella enterica serotype Newport Isolates from Human and Food Animal Infections and Retail Meat.
H. Harbottle

N-16
E. coli resistant to third-generation cephalosporins show decreased cefquinome susceptibility.
J. Hayes

N-17
Comparison of antimicrobial susceptibility profiles among Salmonella spp. recovered from retail poultry, NARMS 2002 vs. 2003.
S.K. Hubert

N-18
Whole genome optical maps of E. coli O157:H7 and related pathogens: investigating strain diversity for microbial forensic applications.
M.L. Kotewicz

N-19
Microbial forensics of foodborne pathogens: An FDA Collaboration with the Department of Homeland Security.
J.E. LeClerc

N-20
Recovery of Bacillus anthracis from two artificially contaminated foods using FERN methodology.
S.M. Madson

N-21
Tracking E. coli O157:H7 strains by genomic comparisons.
M.K. Mammel

N-22
Temperature Affects on Lateral Flow Devices Used in the Detection of Ricin in Food Matrices.
M.A. McLaughlin

N-23
Recovery of Enterobacter sakazakii and Klibsiella pneumonia from infant formula by filtration and cultivation on a unique infrared-transparent hydrophilic membrane filter.
M.M. Mossoba

N-24
An assessment of preharvest source tracking and transverse movement of Salmonella Heidelberg population on a turkey grow-out facility.
R. Nayak

N-25
Salmonella population dynamics in preharvest turkey environment: In vitro antimicrobial susceptibility phenotypes of multi-drug resistant serovars.
R. Nayak

N-26
Detection of Staphylococcal Enterotoxins in Various Matrices with Commercial Kits.
C.W. Noah

N-27
A real time PCR Assay for the Detection of Toxigenic Vibrio cholerae.
J. Nordstrom

N-28
Comparative genomic analysis of E. coli O157:H7 using a novel high-density, high-throughput DNA microarray platform.
I.R. Patel

N-29
Bovine Immune Globulins are an Effective Post-Exposure Prophylaxis against Anthrax Parenteral & Aerosol Spore Challenge in Mice.
J.L. Riemenschneider

N-30
Detection of Peanut Protein in Chocolate using Mass Spectrometry.
K.J. Shefcheck

N-31
An Experimental Model Assessing Chemical-Microbial Interactive Neurobehavioral Toxicity.
T.J. Sobotka

N-32
Anthrax lethal toxin alters chemokine release by human lung microvascular endothelial cells.
A.D. Steele

N-33
Characterization of Virulence Factors Expressed by Vibrio alginolyticus Isolates Obtained from Teleosts and Elasmobranchs Housed in a Public Aquarium and Aquaculture Facility.
B.D. Tall

N-34
Determination of Unknown Toxicants in Flour Tortilla by Sequential Extraction: Preliminary Report.
S. Trujillo

N-35
CFSAN Outbreak Surveillance Database.
K. Vierk

N-36
Anthrax Lethal Toxin Induces Human Endothelial Barrier Dysfunction.
J.M. Warfel

N-37
Quantitative determination of thallium binding to Prussian Blue.
Y. Yang

N-38
Development of a Lyophilized Reagent Format Real-time PCR Assay for the Simultaneous Indentification of Shiga-toxin Producing Escherichia coli (STEC) and E. coli O157:H7 with Incorporation of an Internal Control.
K.J. Yoshitomi

N-39
Real-time PCR Technology Transfer to FDA and State FERN Laboratories Through Laboratory Training and Test Samples.
K.J. Yoshitomi

N-40
FDA's Most Wanted Flies.
G.C. Ziobro

N-PO-41
DNA Markers for Identifying Humans: How Many SNPs?.
R.L. Bernstein

O. REGULATORY SCIENCES

O-02
Acute hemodynamic and hemolytic effects of intravenously administered ethylene glycol in the pig: Implications for ethylene oxide sterilization residues standard (ISO 10993-7).
R. Brown

O-03
Clinical Data Presentations for Orthopedic Device Applications.
B. Buch

O-05
Effect of Sorbitol on Bioequivalence of Ranitidine Oral Solutions.
M. Chen

O-06
Effects of zearalenone on in utero development of rats.
T.F. Collins

O-07
The PEPFAR Program: Bioequivalence Issues for Fixed-Dose Combination and Co-Packaged Drug Products for Treatment of HIV.
B.M. Davit

O-08
“Estimating Intake of Flavors: Is there a “better” method?”.
D.L. Doell

O-09
THE PRODUCT QUALITY RESEARCH INSTITUTE IMPURITY CHARACTERIZATION AND QUANTIFICATION BEST PRACTICES SURVEY.
P.J. Faustino

O-10
Iontophoretic Delivery of Anesthetic and Analgesic Drugs: Design Evolution and Regulatory Challenges.
R.S. Harapanhalli

O-11
Comparability Protocols for Small Molecule Drugs in NDAs and Supplemental NDAs: Regulatory Issues and Challenges.
R.S. Harapanhalli

O-12
Methods of Manufacture That Remove Contaminants From Fish Oils: information compiled through the GRAS (generally recognized as safe) notification program.
C.A. Hendrickson

O-13
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.
V.M. Holt

O-14
Points to Consider in the Design of Nonclinical and Clinical Evaluations of Products Intended to Repair or Replace Articular Cartilage.
A. Kaiser

O-15
Visual Analog Compared with Categorical Scale for Acute Pain Measurement.
M. Katzper

O-16
LABELING OF DRUGS THAT INTERACT WITH ORAL CONTRACEPTIVES.
M. Kim

O-17
Guidance for Industry on the Development of Decorporation Agents for Internal Radioactive Contamination.
T. Kokate

O-18
Bioequivalence of Highly Variable Drugs in Generic Drug Applications.
D. Patel

O-19
COMPLEXITIES OF THE BOTANICAL NOMENCLATURE SYSTEM IN TRADITIONAL CHINESE MEDICINE (TCM): LESSON LEARNED FROM ARISTOLOCHIA AND IMPORTANCE OF THE PHARMACEUTICAL NAME.
K. Wu

O-PO-20
Bioequivalence Study Recommendations Guidance, a Critical Path Initiative.
W. Adams

O-PO-21
Regulatory Aspects of Total Product Life Cycle.
S.S. Altaie

O-PO-22
Recommended Exposure Schedules for Indoor Tanning: Explorations to improve current FDA guidance.
S.A. Miller

O-PO-23
A key to the genera of commonly imported seaweeds.
L.A. Solorzano

P. VALIDATION, TESTING, STANDARDIZATION, AND QUALITY ASSURANCE

P-01
Detection of 10 Infectious Units of Pathologic Prion Protein From Scrapie Infected Hamster Brain Homogenates Using Real-time Immuno-PCR (IPCR).
J. Barletta, Ph.D.

P-02
Development of a Broth Microdilution Susceptibility Testing Method for Campylobacter.
S.M. Bodeis-Jones

P-03
Dissolution of Atropine Sulfate tablets and of extended release Hyoscyamine Sulfate tablets or capsules.
U.R. Cieri

P-04
A Novel Quantitative PCR Internal Control System Adaptable to any Standard or Real-Time PCR Assay.
A. DePaola

P-05
Prioritizing sources of variability in genomic microarray data (OSHC inter-center project).
R.K. Elespuru

P-06
Feasibility Testing and Development of a Rapid Detection and Identification System for Mollicutes Using a Microarray-Based Assay.
J.M. George

P-07
Evaluation of multiple NAT and serologic assays for detection of HIV variants in Cameroonian blood samples.
I. Hewlett

P-08
Use of Standards in the Review of Medical Devices.
C. Ho

P-09
Differentiation of Generic and Innovator Pharmaceutical Products Using Near Infrared Spectroscopy.
S. Jenney

P-10
A Three-Phase Evaluation of the Feasibility to Extend the Storage Life of In-House Prepared Plates of Xylose-Lysine-Desoxycholate and Hektoen Enteric Agar Media for Salmonella Recovery in Foods.
J. Kinney

P-11
A Sampling Strategy for Monitoring Adverse Event Coding Errors in e-AER Submissions.
Q. Li

P-12
Development of Digoxigenin Labeled ipaH DNA Probe for Shigella spp. Detection.
W.S. Lin

P-13
Potential Impurities Generated from Ethylene Oxide Sterilization Process.
Y. Lu

P-14
Normal Flow Virus Filtration – Detection and Assessment of Endpoint in Bioprocessing.
S. Lute

P-15
Robustness of virus removal by Protein A chromatography is independent of media lifetime and mechanism of degradation.
S. Lute

P-16
Materials Issues in the Post-Market Experience of the Ferric Hyaluronan Adhesion Prevention Solution (Fe-HA).
H.D. Luu

P-17
EVALUATION OF K6/ODC TRANSGENIC MICE AS A DERMAL CARCINOGENICITY MODEL FOR ONCOGENIC DNA.
T.J. Miller

P-18
Evaluation of Microarray Data Variability within Commercial Microarray Surfaces.
D.G. Ranamukhaarachchi

P-19
One-sided and Two-sided Sequential Tests for Quality Assurance of Drug Products.
Y. Tsong

P-20
Parametric Two-Stage Sequential Quality Assurance Test of Content Uniformity of Drug Products.
Y. Tsong

P-21
A Statistical Power Analysis for Average Bioequivalence Study Using Replicated Crossover Design: Case Study.
D. Yim

Q. SCIENCE COMMUNICATION, POLICY, LEVERAGING, OUTREACH

Q-01
Making FDA's Toxicological, Human Adverse Effect, and Chemical Data Available at Your Desktop.
R. Benz

Q-03
Outreach in the Division of Biotechnology and GRAS Notice Review—Explaining FDA’s Policy on Bioengineered Foods and the Consultation Process to Diverse Audiences.
S.J. Carlson

Q-04
Using the CFSAN Thesaurus to improve scientific communication.
L.R. Dusold

Q-05
Committee for the Advancement of FDA Science (CAFDAS): The FDA Scientist’s Liaison to the Commissioner’s Office.
R.M. Fahmy

Q-06
Old Borax.
E.-. Grundel

Q-07
Role and Use of Guidance Documents and Standards for Submission of Applications for Combination and Human Cell, Tissue, and Cellular and Tissue-based Products to the Food and Drug Administration.
D.S. Kaplan

Q-08
THE FAILED PRECEPTS OF CARDIOTOCOGRAPHY IN RELATION TO ADVERSE OUTCOMES OF VACUUM ASSISTED DELIVERIES.
D. Marinac-Dabic

Q-09
Neurological Implants with Lead Systems and Magnetic Resonance Imaging: Adverse Events and Prevention.
N.A. Pressly