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Sigma Xi
The Scientific Research Society
Food and Drug Adminstration Chapter

2006 FDA Science Forum
Poster Abstracts by Category and Section

 

CATEGORY A: ANALYTICAL CHEMISTRY: METHODS DEVELOPMENT AND APPLICATIONS
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  1. A-01
    Surface Plasmon Resonance Biosensor Analysis for Chloramphenicol Residue Determination in Crab and Shrimp
    W. C. Andersen1 , S. B. Turnipseed1 , C. M. Karbiwnyk1 , L. E. Carr2 , R. H. Lee2 , M. R. Madson2 , K. S. Kreuzer2 , 1Animal Drug Research Center, FDA, Denver, CO 80225, 2Denver District Laboratory, FDA, Denver, CO 80225

  2. A-02
    Compton Suppression Spectrometry for Analysis of Short-lived Neutron Activation Products in Foods
    D. L. Anderson, W. C. Cunningham, CFSAN, FDA, College Park

  3. A-03
    Characterizing perfluorochemical migration from food contact paper.
    T. H. Begley, W. Hsu, G. W. Diachenko, CFSAN, FDA, College Park, MD

  4. A-04
    Determination of Side-Reaction Products and an Intermediate in the Color Additives D&C Red Nos. 21 and 22 (Eosin Y) using High-Performance Liquid Chromatography
    H. W. Yang1 , H. T. Mai1 , A. Weisz2 , 1Office of Cosmetics and Colors, Color Certification Branch, FDA College Park, MD, 20740, 2Office of Cosmetics and Colors, Color Technology Branch, FDA College Park, MD 20740

  5. A-05
    Overcoming the Bottleneck of Sample Preparation using Tablet Processing Workstation
    I. Vertsman, Y. T. Cain, Wyeth Research, Wyeth

  6. A-06
    Ion Mobility Spectrometry - Successful Implementations and The Path Forward
    Y. T. Cain, M. Meyers, Wyeth Research, Wyeth

  7. A-07
    Rapid Packaging ID of Pharmaceutical Drug Product using Fiber Optic Probe Fluorescence Spectroscopy
    Y. T. Cain, M. Meyers, Wyeth Research, Wyeth

  8. A-08
    Fiber Optic Dissolution: The Future
    Y. T. Cain, J. L. Edgar, Wyeth Research, Wyeth

  9. A-09
    Analysis of erythromycin residues in salmon by LC-MS-MS
    S. Smith, C. S. Cheely, C. Gieseker, R. Reimschuessel, M. C. Carson, CVM, FDA, Laurel, MD

  10. A-10
    Determination of Total Bound and Free Residues of Nitrofurans in Milk of Lactating Cows Using Liquid Chromatography/Tandem Mass Spectrometry
    P. Chu, M. Lopez, CVM, FDA, Laurel, MD

  11. A-11
    Determination of Trace Amounts of Penicillin in Cephalosporins by Liquid Chromatography
    D. Dai, S. Wang, NRL, FDA, Jamaica, NY

  12. A-12
    Development of a SPME-GC-MS Method for the Determination of Coumarin in Vanilla Extract
    L. S. de Jager, G. A. Perfetti, G. W. Diachenko, CFSAN, FDA, College Park MD

  13. A-13
    A novel method of measuring mass loss from bioresorbable polymers containing optically-active compounds
    Q. Ge, R. V. Bahulekar, P. M. Amin, M. W. Diamond, F. M. Buevich, F. T. Do, R. A. Ebelle, S. K. Pulapura, A. C. Moses, W. C. McJames, TyRx Pharma, Inc.

  14. A-14
    Seafood Biotoxin Risk Management Success Story: 2005 New England Paralytic Shellfish Poisoning (Non)-Event
    S. M. Etheridge1 , J. R. Deeds1 , S. M. Conrad1 , S. Hall1 , P. DiStefano2 , M. Ellwanger2 , K. Chu3 , F. Pettengill4 , M. Hickey5 , D. Couture6 , 1OS, CFSAN, FDA, Laurel, MD, 2OS, CFSAN, FDA, College Park, MD, 3NOAA Fisheries Service, Gloucester, MA, 4Div. of Marine Fisheries, Gloucester, MA, 5MA Marine Fisheries, Pocasset, MA, 6Dept. of Marine Resources, W. Boothbay Harbor, ME

  15. A-15
    Size exclusion chromatography (SEC) with refractive index detection to assess the molecular weight (MW) of polysaccharides
    R. B. Shah, Y. Yang, M. A. Khan, P. J. Faustino, Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Science, FDA, Silver Spring, MD

  16. A-16
    Detection and Structural Characterization of Phosphodiesterase-5 Inhibitor Analogs in Suspect Counterfeit Products and Dietary Supplements
    S. R. Gratz, R. A. Flurer, M. R. Witkowski, C. L. Flurer, Forensic Chemistry Center, FDA, Cincinnati, OH

  17. A-17
    Studies of Variability in Dissolution Testing with USP Apparatus 2
    Z. Gao, T. Moore, A. Smith, W. H. Doub, B. J. Westenberger, L. F. Buhse, FDA

  18. A-18
    Generic Drug Products Demonstrate Small Differences in Bioavailability Relative to the Brand Name Counterparts: A Review of ANDAs Approved 1996 - 2005
    P. E. Nwakama, S. H. Haidar, Y. S. Yang, B. M. Davit, D. P. Conner, L. X. Yu, CDER, FDA, Rockville, MD

  19. A-19
    DIOXINS AND FURANS FOUND IN OLIVE OIL
    M. K. Halbert, J. C. Archer, ARL, FDA

  20. A-20
    Production and purification of marine biotoxins to support FDA research and regulatory programs
    S. Hall, S. M. Etheridge, J. R. Deeds, S. M. Conrad, WSL, OS, CFSAN, FDA, Laurel, MD

  21. A-21
    Automation for Isomer Specific Determination of Polychlorinated dibenzo-p-dioxins/furans, Polychlorinated biphenyls and Polybrominated diphenyl ethers in Foods and Feeds
    D. G. Hayward1 , T. S. Pisano2 , 1CFSAN, FDA, College Park, MD, 2JIFSAN, University of Maryland, College Park, MD

  22. A-22
    Method for determining fat in freeze-dried cow's milk during an automated extraction and purification procedure for halogenated organic pollutants
    T. S. Pisano1 , D. G. Hayward2 , 1JIFSAN, University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD

  23. A-23
    Method to Enforce Lead and Arsenic Specifications in Bone Black (D&C Back No. 3) Using X-Ray Fluorescence Spectrometry
    N.M. Hepp, Office of Cosmetics and Colors, CFSAN, FDA, College Park, MD

  24. A-24
    Determination of Methylmercury and Estimation of Total Mercury in Seafood by High Performance Liquid Chromatography (HPLC) and Inductively Coupled Plasma-Mass Spectrometry (ICP MS): Method Development and Ratio of Methyl/Total Mercury in Seafood
    S. C. Hight, J. Cheng, FDA

  25. A-25
    Determination of Retinol, Retinyl Palmitate and Retinoic Acid in Consumer Cosmetic Products
    J. C. Hubinger, D. C. Havery, Office of Cosmetics and Colors, CFSAN, FDA, College Park, MD

  26. A-26
    Comparison of Escherichia O157:H7 isolates using a multilocus variable-number tandem repeat analysis (MLVA)
    J. N. Jean-Giles, G. L. George, J. E. LeClerc, T. A. Cebula, Mod-1

  27. A-PO-27
    A Quick Method for Identification of Certifiable Color Additives By FTIR
    A. N. Joshi, J. Nickelsen, G. Gavini, FDA

  28. A-28
    NMR - An alternative method to Measure pKa.
    P. A. Jupp, D. Trew, C. H. Turner, Wyeth Research

  29. A-29
    Sensitive Liquid Chromatography/Tandem Mass Spectrometry Method for the Quantitation and Confirmation of Oxytocin in a Dilute IV Saline Solution
    C. M. Karbiwnyk1 , K. C. Faul2 , S. B. Turnipseed1 , W. C. Andersen1 , K. E. Miller3 , 1ORA, Animal Drugs Research Center, FDA, Denver, CO, 2ORA, FDA, Denver, CO, 3Univ. of Denver, Denver, CO

  30. A-30
    Establishment of ELISA for Quantification of Human Alpha-1-Proteinase Inhibitor
    E. Karnaukhova, B. Golding, Y. Ophir, Division of Hematology, CBER, FDA, Bethesda, MD

  31. A-31
    In vitro Complexes of Human Alpha-1-Proteinase Inhibitor with Retinoic Acid. A search for bi-functional drugs for treatment of human emphysema
    E. Karnaukhova, Division of Hematology, CBER, FDA, Bethesda, MD 20895

  32. A-32
    Interaction of Human Serum Albumin with Retinoids
    E. Karnaukhova, Division of Hematology, CBER, FDA, Bethesda, MD 20895

  33. A-33
    Separation, characterization and quantification of an unexpected degradant formed from tocopherol succinate polyethylene glycol using HPLC, LC-MS and NMR
    I. P. Leader, P. A. Jupp, P. Weatherhead, V. Huynh, D. Trew, C. H. Turner, T. Day, D. Wheatley, WYETH RESEARCH

  34. A-34
    Development of an LC/MS quantitative method for sulfadimethoxine residue and major metabolite in bovine tissues and fluids
    H. Li, P. J. Kijak, J. von Bredow, A. Chiesa, M. L. Smith, CVM, FDA, Laurel, MD

  35. A-35
    Simultaneous Quantitative Analysis of Histamine, Putrescine and Cadaverine of Scombroid Fish Samples and Fishery Products by Cationic Ion Chromatography
    B. S. Liao, T. T. Cain, PRL/SW, FDA, Irvine, CA

  36. CSC Winning Poster Ribbon iconA-36
    Determination of Nitrofuran Residues in Honey
    M. Lopez1 , M. Feldlaufer2 , P. Chu1 , 1CVM, FDA, 2ARS, USDA

  37. A-37
    Thermogravimetric Methods: Applications to Determination of Residual Moisture in Freeze-Dried Biological Products
    J. C. May1 , N. M. Etz1 , H. Wang1 , L. Rey2 , 1CBER, FDA, Rockville, MD, 2Conseiller Scientifique, Lausanne, Switzerland

  38. A-38
    Rapid Determination and Confirmation of Four Fluoroquinolone Residues in Fish Tissue
    S. E. McMullen, V. A. Vega, F. J. Schenck, SRL, Atlanta, GA

  39. A-39
    Novel Fluorometric Assay for Hydroxyl Radical Scavenging Capacity (HOSC) Estimation
    J. C. Moore1 , J. J. Yin2 , L. Yu1 , 1Dept. of Nutrition and Food Science, University of Maryland, College Park, MD, 2FDA, CFSAN, College Park, MD

  40. A-41
    Assessment of Tests Marketed for Detection Ruminant Proteins in Finished Feed
    H. F. Yancy, D. E. Farrell, J. D. Washington, C. M. Deaver, R. A. Frobish, CVM, FDA, Laurel, MD

  41. A-42
    Determination of MS-222 residues in farmed fish
    C. B. Nochetto, C. S. Cheely, C. Gieseker, R. Reimschuessel, M. C. Carson, CVM, FDA

  42. A-43
    Screening and Confirmatory Methods for the Detection of Monofluoroacetic Acid in Foods by Liquid Chromatography Mass Spectrometry.
    G. O. Noonan, T. H. Begley, G. W. Diachenko, CFSAN, FDA, College Park, MD

  43. A-44
    Determination of HKI-272 in Human Plasma by LC/MS/MS
    M. Hamed, L. Mello, M. Osman, Bioanalytical R&D, Wyeth Research, Collegeville, PA

  44. A-45
    Determination of PSI-697 in Human Plasma by LC/MS/MS
    L. Mello, S. Mathews, M. Khan, M. Osman, Bioanalytical R&D, Wyeth Research, Collegeville, PA

  45. A-46
    Stability-Indicating Method for Glycopyrrolate in Compounded Glycoprrolate Oral Suspension Formulae
    S. H. Atwell, P. A. White, S. Z. Wahab, United States Pharmacopeia

  46. A-47
    Method Development and Validation of an HPLC Assay Method for the Quantitation of Trimethoprim in Compounded Oral Preparations
    A. Ashley, R. Maheswaran, J. L. Belsky, S. Z. Wahab, United States Pharmacopeia

  47. A-48
    Method Development and Validation of an HPLC Assay Method for the Quantitation of Flecainide in Compounded Preparations of Flecainide Oral Suspensions
    R. Maheswaran, P. A. White, S. Z. Wahab, United States Pharmacopeia

  48. A-49
    Evaluation of Ginger Capsules by Dissolution Profile and Content of Marker Compounds
    E. Biba, L. R. Strauch, S. Z. Wahab, P. A. White, United States Pharmacopeia

  49. A-50
    Experimental Design for Dissolution Variance Study of USP Prednisone Tablets
    G. Deng1 , A. Ashley1 , W. Brown1 , J. Eaton1 , M. Liddell1 , L. Kikwai-Mutua1 , R. Manning1 , J. Munoz1 , B. Ning1 , P. Nithyanandan1 , H. Rowe1 , S. Tan1 , S. Z. Wahab1 , W. Hauck2 , 1United States Pharmacopeia, Rockville, MD, 2Thomas Jefferson University, Philadelphia, PA

  50. A-51
    Chemical and Physical Characteristics of USP Prednisone Tablets Lot P
    G. Deng, W. Brown, B. Chow, J. Eaton, M. Glasgow, M. Goede, L. Kikwai-Mutua, R. Manning, L. Wang, S. Z. Wahab, United States Pharmacopeia

  51. A-52
    USP Apparatus 4 Dissolution Profile of Prednisone Tablets Lot P
    J. Eaton, G. Deng, W. Brown, R. Manning, S. Z. Wahab, United States Pharmacopeia

  52. A-53
    GAS CHROMATOGRAPHIC ANALYSIS OF SUGARS AND SUGAR ALCOHOLS IN FOODS OF LOW CARBOHYDRATE CONTENT
    J. L. Perry, M. P. Yurawecz, CFSAN, FDA, College Park, MD

  53. A-54
    Direct Method for the Determination of Sudan I in FD&C Yellow No. 6 by Reversed-Phase High Performance Liquid Chromatography
    B. R. Petigara, A. L. Scher, CFSAN, FDA, College Park, MD

  54. A-55
    Direct Method for the Determination of Sudan I in D&C Orange No. 4 by Reversed-Phase High Performance Liquid Chromatography
    B. R. Petigara, A. L. Scher, CFSAN, FDA, College Park, MD

  55. A-56
    Immuno-Affinity Centrifugal Precipitation Chromatography: Pilot Studies
    L. Qi1 , Y. Ito2 , 1ONDQA, CDER, FDA, 2Center for Biochemistry and Biophysics, NHLBI, NIH

  56. A-57
    Use of HPLC analysis of ginsenoside content to develop a cost comparison among ten commercially available ginseng products.
    L. Caputo1 , N. Barnoy1 , J. Kim1 , J. Park1 , K. Senthil1 , P. Stahl1 , P. Delmonte2 , 1U.Md., 2CFSAN, FDA, College Park, Md.

  57. A-58
    Use of liquid chromatography-mass spectrometry and a hydrolytic technique for the detection and structure elucidation of a novel synthetic vardenafil designer drug added illegally to a "natural" herbal dietary supplement
    J. C. Reepmeyer, J. T. Woodruff, Division of Pharmaceutical Analysis, CDER, FDA, St. Louis, MO

  58. A-59
    DEVELOPMENT AND VALIDATION OF A MICROARRAY-BASED ASSAY THAT RAPIDLY DETECTS GENETIC VARIABILITY IN WEST NILE VIRUS GENOME.
    A. Grinev1 , S. Daniel1 , M. Laassri2 , K. Chumakov2 , V. E. Chizhikov2 , I. K. Hewlett1 , M. Rios1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2OVRR/CBER/FDA, Rockville, MD

  59. A-60
    Determination of usnic acid in toxic lichen by liquid chromatography with ultraviolet and tandem mass spectrometry detection
    J.A. Roach, CFSAN, FDA, College Park, MD

  60. A-61
    Determination of Avermectin Residues in Raw Milk, Pasteurized Whole Milk and Pasteurized Skim Milk using HPLC with Fluorescence Detection
    W. D. Rowe1 , M. R. Madson1 , J. N. Sofos1 , F. J. Schenck2 , V. A. Vega2 , L. H. Lagman3 , D. M. Altwein4 , 1FDA, Denver, CO, 2FDA, Atlanta, GA, 3FDA, Jefferson, AR, 4FDA, Bothell, WA

  61. A-62
    Development of Official Analytical Methods and Reference Materials for Dietary Supplements
    J. M. Betz1 , L. G. Saldanha1 , M. J. Smith2 , B. J. Cañas2 , Y. Tokiwa2 , L. C. Sander3 , K. E. Sharpless3 , S. A. Wise3 , 1Office of Dietary Supplements, NIH, Bethesda, MD, 2CFSAN, College Park, MD, 3National Institute of Standards and Technology , Gaithersburg, MD

  62. A-63
    Forensic Chemistry Center: Solutions to Current Forensic Challenges Using Multiple Analytical Approaches
    R.D. Satzger, FCC, ORA, FDA, Cincinnati, OH

  63. A-64
    Determination of Chlorothalonil Pesticide Residues in Produce Samples: Analytical Difficulties
    F. J. Schenck, S. E. McMullen, Southeast Regional Laboratory, FDA, Atlanta, GA

  64. A-65
    Isotopic Labeling Method for Quantitation of Peanut Allergens using Mass Spectrometry.
    K. J. Shefcheck, J. H. Callahan, S. M. Musser, CFSAN, FDA, College Park, MD

  65. A-66
    Intact Protein Biomarker Discovery for Determining Animal Host of Salmonella enterica serovar Newport
    T. L. Williams1 , R. Singh2 , H. C. Harbottle3 , D. Andrezjewski1 , D. N. Heller3 , R. D. Walker3 , S. M. Musser1 , 1CFSAN, FDA, College Park, MD 20740, 2CVM, FDA, Rockville, MD 20855, 3CVM, FDA, Rockville, MD 20708

  66. A-67
    Analysis of Aminoglycosides in Animal Feed by LC/MS
    M. L. Smith, D. N. Heller, CVM-OR, FDA, Laurel, MD

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

  68. A-69
    Analysis of dietary supplements containing Blue Cohosh (Caulophylum thalictroides) for major alkaloids and saponins by high performance liquid chromatography (HPLC)
    S. Satchithanandam1 , M. Ganzera2 , E. Grundel1 , K. D. White1 , J. I. Rader1 , 1CFSAN, FDA, College Park, MD, 2University of Innsbruck, Innrian 52, Austria

  69. A-70
    Use of LC/MS and NMR to identify selected diterpenoids in methanol extracts of authenticated Teucrium chamaedrys L. and T.canadense (Germander)
    P. R. Sundaresan1 , E. Grundel1 , K. D. White1 , E. Mazzola2 , J. I. Rader1 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA & Univ. MD, MD

  70. A-71
    Characterization of CMD-193, a Calicheamicin-Anti-Lewis Y Monoclonal Antibody Conjugate Using LC-MS and LC-MS/MS
    J. X. Tang, E. Vidunas, J. Moran, P. Desai, M. Ruppen, Wyeth Research, 401 North Middletown Road, Pearl River, NY 10965

  71. A-72
    LC-APPI-MS of Steroids and Small Organic Molecules Using PhotoSprayTM Ion Source
    J. X. Tang, R. Tsao, Wyeth Research, 401 North Middletown Road, Pearl River, NY 10965

  72. A-73
    Improved Method of Analysis for Histamine in Canned Fish without Derivatization
    S. Tefera, S. Ehling, S. J. Yoo, I. P. Ho, Food Products Association (FPA), Washington, DC

  73. A-74
    Determination of Aflatoxins in Ginseng Herbal Supplements
    E. Yanik1 , L. Lenz1 , C. M. Weaver2 , C. J. Oles3 , M. W. Trucksess2 , 1University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD, 3CFSAN, FDA,College Park, MD

  74. A-75
    Determination of Fumonisin B1 in Botanical Roots
    M. W. Trucksess1 , C. M. Weaver1 , C. J. Oles1 , J. I. Rader2 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA,College Park, MD

  75. A-76
    Development of a multi-class multi-residue LC-MS screening method for drugs residues in milk
    S. B. Turnipseed1 , C. M. Karbiwnyk1 , W. C. Andersen1 , S. B. Clark1 , K. E. Miller2 , 1ORA, FDA, Denver, CO, 2University of Denver, Denver, CO

  76. A-77
    Sulfite Determination in Dried Fruits: A Comparison of the Monier-Williams Procedure and Anion Exchange Chromatography
    J. R. Urban, D. S. Jackson, US FDA, Forensic Chemistry Center, Cincinnati, OH

  77. A-78
    IN VITRO GASTRIC AND INTESTINAL STABILITY OF VENLAFAXINE
    E. B. Asaju-Adjaye, P. J. Faustino, M. A. Tawakkul, D. A. Volpe, DPQR, CDER, FDA, Silver Spring, MD

  78. A-79
    A Novel Animal Model for Detecting Damage to Human Platelet Transfusion Products: In Vivo Recovery and Survival in Severe Combined Immunodeficient Mice.
    J. T. Piper, J. G. Vostal, CBER, FDA, Bethesda, MD

  79. A-80
    Analysis for Formaldehyde in influenza virus vaccines by an HPLC method
    H. Wang, N. M. Etz, J. C. May, CBER, FDA, Rockville, MD

  80. A-81
    Unravel the Mystery of NONMEM Estimation Methods by Visualization
    Y. Wang, CDER, FDA, Rockville, MD

  81. A-82
    Investigation of Flour Tortillas Implicated in Episodes of Illnesses Associated with School Lunches
    C. R. Warner1 , G. O. Noonan1 , N. Sugimoto2 , A. Beisaw3 , W. Hsu3 , G. A. Perfetti1 , T. H. Begley1 , G. W. Diachenko1 , 1FDA, College Park, MD, 2National Institutes of Health Sciences, Tokyo, 3JIFSAN, University of Maryland, College Park, MD

  82. A-83
    Antimicrobial Resistance and Genetic Relatedness among Salmonella from Retail Foods of Animal Origin: NARMS Retail Meat Surveillance
    S. Zhao1 , P. F. McDermott1 , S. Friedman1 , J. W. Abbott1 , S. L. Ayers1 , A. Glenn1 , E. Hall-Robinson1 , S. K. Hubert1 , H. C. Harbottle1 , R. D. Walker1 , T. M. Chiller2 , D. G. White1 , 1CVM, FDA, Rockville, MD, 2CDC, Atlanta, GA

  83. A-84
    Differentiation of Enterobacter sakazakii from closely related Enterobacter and Citrobacter species using fatty acid profiles
    P. Whittaker1 , C. E. Keys1 , E. W. Brown1 , B. D. Tall2 , S. G. Edelson-Mammel1 , F. S. Fry1 , 1CFSAN, FDA, College Park, MD, 2CFSAN, FDA, Laurel, MD

  84. A-85
    Quality by Design in Analytical Chemistry
    L. J. Wrisley, L. Zhang, Wyeth Research

  85. A-86
    Gas chromatography/mass spectrometry determination of carbon monoxide in commercially treated tuna and mahi-mahi
    W. H. Wu, C. R. Anderson, PRLNW/SPRC, ORA, FDA, Bothell, WA

  86. A-87
    Effects of Conjugated Linoleic Acid (CLA) Isomers on Oxygen Diffusion-Concentration Products in Liposomes and Phospholipid Solutions
    J. J. Yin1 , M. P. Yurawecz2 , J. K. Kramer3 , A. R. Eynard4 , L. Yu5 , 1CFSAN, FDA, College Park, MD, 2Retired, 3Agri-Food Canada, 4Universidad Nacional de Córdoba, Argentina, 5University of Maryland

  87. A-88
    Accurate Identification of Trans Fatty Acid Methyl Ester Peaks Using GC-FID on a Polar Capillary Column
    S. J. Yoo, E. Kwok, I. P. Ho, Food Products Association (FPA), Washington, DC

  88. A-PO-89
    SIMULATED FIELD APPLICATION OF PEDXRF FOR THE DETECTION OF ACUTE LEVELS OF SOME TOXIC ELEMENTS IN TWO MODEL FOODS
    R. M. Jacobs1 , P. T. Palmer2 , 1ORA,FDA, Alameda, CA, 2SFSU, San Francisco, CA

  89. A-PO-90
    PEDXRF - A FASTER, SIMPLER, AND CHEAPER ALTERNATIVE TO ATOMIC SPECTROMETRY FOR SCREENING OF PPM TO PERCENT LEVELS OF TOXIC ELEMENTS IN FOODS AND MEDICINES
    P. T. Palmer1 , R. M. Jacobs2 , K. Yamamoto3 , S. Webber3 , K. Ferguson3 , 1SF District Lab & SF State University, San Francisco, CA, 2SF District Lab, Alameda, CA, 3SF State University, San Francisco, CA

  90. A-91
    Development of an LC-UV Method for the Determination of Coumarin in Vanilla Extract
    L.H. Ali, G.A. Perfetti, and G.W. Diachenko, CFSAN, FDA

    CATEGORY B: BIOLOGICAL ENDPOINTS: MICROBIOLOGY, VIROLOGY, ALLERGENICITY, BIOCHEMISTRY, TOXICOLOGY
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  91. B-01
    ALTERATIONS IN BLOOD-BRAIN BARRIER FUNCTION BY MORPHINE AND METHAMPHETAMINE
    H. S. Sharma1 , S. F. Ali2 , 1University of Uppsala, Sweden, 2NCTR, FDA, Jefferson, AR

  92. B-02
    Increasing Confidence Level in DNA Microarray Chip Hybridization Data of 71 Genes with PCR Amplification of 10 genes in Salmonella Typhimurium
    S. F. Al-Khaldi1 , S. Courtney2 , M. E. Mossoba1 , T. S. Hammack1 , C. E. Keys1 , 1CFSAN,FDA, College Park, MD, 2JIFSAN,FDA, College Park, MD

  93. B-03
    Evaluation of Commercially Available ELISA-Based Kits for Protein Fining Agents in Wine
    J. R. Ammann1 , M. A. Mabud1 , E. A. Garber2 , 1Alcohol and Tobacco Tax and Trade Bureau, US Treasury Dept., Beltsville, MD 20705, 2CFSAN, FDA, College Park, MD 20740

  94. B-04
    Differential reactive oxygen and nitrogen production and clearance of Salmonella serovars by chicken and mouse macrophages
    U. S. Babu1 , D. W. Gaines1 , H. Lillehoj2 , R. B. Raybourne1 , 1FDA, Mod I, Laurel, MD, 2USDA, Beltsville, MD

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

  96. B-06
    Aminoglycoside Resistance Genes Found in Enterococcus spp. Recovered From Retail Meats
    S. M. Bodeis-Jones, D. G. White, T. NARMS Working Group, FDA, CVM, Office of Research, Laurel, MD

  97. B-07
    Intraperitoneal administration of lipopolysaccharide (LPS) produces a stable juvenile pig model of endotoxemia for toxicity testing of compounds released from medical device materials
    D. Wray-Cahen1 , R. P. Brown1 , A. I. Steen2 , H. Baskar3 , M. E. Stratmeyer1 , 1MOD2, CDRH, FDA, Laurel, MD, 2ODE, CDRH, FDA, Rockville, MD, 3University of Maryland

  98. B-08
    Intravenously administered ethylene glycol (EG) produces hemolysis and hemodynamic changes in the pig
    R. P. Brown1 , D. Wray-Cahen2 , A. D. Lucas1 , A. I. Steen3 , H. Baskar4 , M. E. Stratmeyer1 , 1CDRH, FDA, Silver Spring, MD, 2CDRH, FDA, Laurel, MD, 3CDRH, FDA, Rockville, MD, 4University of Maryland, College Park, MD

  99. B-09
    Cytotoxicity of extracts from ethylene oxide-sterilized cardiopulmonary bypass oxygenators
    R. P. Brown1 , A. D. Lucas1 , V. M. Hitchins1 , M. D. O'Hara1 , T. L. Murray2 , W. H. Cyr1 , M. E. Stratmeyer1 , S. F. Ali3 , M. Srivatasan4 , 1CDRH, FDA, Silver Spring, MD, 2CDRH, FDA, Laurel, MD, 3NCTR, FDA, Jefferson, AR, 4Arkansas State University, Little Rock, AR

  100. B-10
    Cell line sensitivity to a cleaning agent and disinfectant used to reprocess single-use medical devices
    H. Baskar1 , A. I. Steen2 , R. P. Brown3 , 1University of Maryland, College Park, MD, 2CDRH, FDA, Rockville, MD, 3CDRH, FDA, Silver Spring, MD

  101. B-11
    Qualitative Analysis of Streptococcus Group A Rapid Antigen Detection Test Kit
    G. S. Bushar1 , R. Shively2 , S. C. Wood1 , M. M. Lightfoote1 , 1CDRH, FDA, Silver Spring, MD, 2CDRH, FDA, Rockville, MD

  102. B-12
    The PE_PGRS33 protein of Mycobacterium tuberculosis induces an immune response that may benefit the pathogen.
    N. Cadieux, V. Dheenadhayalan, M. Parra, M. J. Brennan, CBER, FDA, Bethesda, MD

  103. B-13
    Bazedoxifene acetate in vitro metabolism
    A. Chandrasekaran, S. Ahmad, W. DeMaio, T. Hultin, R. Talaat, J. A. Scatina, Department of Biotransformation, Wyeth Research, Collegeville, PA

  104. B-14
    Multi-virulence-locus sequence typing identifies epidemic clones from numerous listeriosis outbreaks
    Y. X. Chen1 , W. Zhang2 , S. J. Knabel1 , 1The Pennsylvania State University, University Park, PA, 16801, 2Illinois Institute of Technology, Summit, Illinois, 60501

  105. B-15
    Precision Treatment of Sand Rats (Psammomys obesus) with Insecticides to Control Phlebotomine Sand Flies (Phlebotomus papatasi): Challenges in Parasite Control and Treatment
    V. M. Chenault1 , M. G. Hodges2 , C. P. Schnupp1 , P. W. Miles3 , V. B. Solberg3 , 1FDA, 2NIH, 3WRAIR

  106. B-16
    Reduced fitness of individual parts of vaccine poliovirus genomes may determine the pattern of their recombination in vivo
    E. Cherkasova1 , E. Korotkova2 , V. Agol3 , K. M. Chumakov1 , 1CBER, FDA, Rockville, MD, 2A. N. Belozersky Institute of Physical-Chemical Biology, Moscow State University, Moscow, Russia, 3M. P. Chumakov Institute of Poliomyelitis and Viral Encephalitides, Russian Academy of Medical Sciences, Moscow, Russia

  107. B-17
    Characterization of Campylobacter recovered from NARMS Retail Meats by Pulsed-Field Gel Electrophoresis
    P. Cullen, S. L. Friedman, J. W. Abbott, L. L. English, A. A. Stearns, P. F. McDermott, S. Zhao, D. G. White, R. D. Walker, FDA, Laurel, MD

  108. B-18
    Evaluation of inactivation methods for severe acute respiratory syndrome coronavirus (SARS-CoV) in non-cellular blood products
    M. R. Darnell, D. R. Taylor, CBER, Office of Blood Research and Review, FDA, Rockville, MD

  109. B-19
    Exploring the programmed cell death pathways of human parasites to identify novel drug targets
    N. Lee, S. Gannavaram, A. Selvapandiyan, A. Debrabant, CBER, FDA, Bethesda, MD

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

  111. B-21
    Effects and Interactions of pH and Water Activity (aw) on the Thermal Resistance of Listeria monocytogenes F4258: Examining the Impact of Acid Adaptation
    S. G. Edelson-Mammel1 , R. C. Whiting2 , S. W. Joseph3 , R. L. Buchanan4 , 1DDES,OPDF, FDA, College Park, MD, 2OPDF, FDA, College Park, MD, 3CBMG, UMD, College Park, MD, 4OSCI, FDA, College Park, MD

  112. B-22
    Inactivation of Escherichia coli O157:H7, Salmonella spp. and Listeria monocytogenes in Cranberry Juice Concentrates
    E. Enache, Y. Chen, Food Products Association, Washington, DC 20005

  113. B-23
    Characterization of a Rodent Pediatric Nephrotoxicity Model
    P. Espandiari1 , T. J. Miller1 , J. Zhang1 , A. D. Knapton1 , P. L. Goering2 , R. P. Brown2 , V. S. Vaidya3 , A. M. Johnson3 , J. V. Bonventre3 , B. A. Rosenzweig1 , K. L. Thompson1 , P. S. Pine1 , S. Schnackenberg4 , R. D. Beger4 , E. H. Herman1 , J. L. Weaver1 , J. P. Hanig1 , 1CDER, FDA, Silver Spring, MD, 2CDRH, FDA, Silver Spring, MD, 3Harvard Medical School, Boston, MA, 4NCTR, Jefferson, AR

  114. B-24
    Anthrax Lethal Toxin Has Direct and Potent Inhibitory Effects on B Cell Proliferation and Immunoglobulin Production
    H. Fang, L. Xu, T. Chen, J. Cyr, D. M. Frucht, DMA,OBP,CDER,FDA

  115. B-25
    Interferon-alpha effectively inhibits replication of HIV-1 in human macrophages, but not T-lymphocytes: Influence of cell type and co-receptor use
    K. H. Fields1 , F. Schwartzkopff1 , R. Hu2 , H. Schmeisser2 , J. Bekisz2 , C. R. Lankford1 , K. Zoon2 , K. A. Clouse1 , 1CDER, FDA, Bethesda, MD 20892, 2NIAID, NIH, Bethesda, MD 20892

  116. Sigma Xi Winning Poster Ribbon iconB-26
    Attachment, growth and differentiation of cryopreserved human hepatocytes in culture - development of a method for studying mechanisms of chemical-induced hepatotoxicity
    T. J. Flynn, C. Y. Kelly, CFSAN, FDA, Laurel, MD

  117. B-27
    Endonuclease G is an important cell death nuclease in trypanosotmatid parasites
    S. Gannavaram, A. Debrabant, Laboratory of Bacterial Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Bethesda, MD 20892

  118. B-28
    Impact of Seven Day Storage on Immunophenotypes and Activities of Cell Membrane Microparticles in Apheresis Platelets
    M. P. Gelderman-Fuhrmann1 , O. Simakova2 , L. B. Carter1 , J. Simak3 , 1FDA, Rockville, MD, 2USUHS, Bethesda, MD, 3DFA, Rockville, MD

  119. B-29
    Role of double stranded RNA (dsRNA) in apoptosis induction by hepatitis A virus
    M. Kulka, B. B. Goswami, T. A. Cebula, D. Ngo, M. Ayodeji, CFSAN, OARSA, FDA, Laurel, MD

  120. B-30
    Detection of Escherichia coli O157:H7 in Produce
    M. A. Grant, R. M. Trump, Pacific Regional Laboratory, Northwest, FDA, Bothell, WA

  121. B-31
    MECHANISM OF ESCAPE FROM HIV PEPTIDE FUSION
    N. Gupta1 , W. Wang2 , E. Desmezieres2 , R. Vassell1 , Y. He1 , P. Wingfield3 , C. D. Weiss2 , 1CBER,FDA,BETHESDA,MD, 2CBER,FDA,BETHESDA,,MD, 3NIH,BETHESDA,MD

  122. B-32
    Effectiveness of the Bacteriological Analytical Manual Salmonella Culture Method for the Recovery of Salmonella Typhi from Selected Foods
    T. S. Hammack, A. P. Jacobson, W. H. Andrews, CFSAN, FDA, College Park, MD

  123. B-33
    Comparison of Salmonella enterica serotype Newport isolates from 1958-2003 using Multi-Locus Sequence Typing and Antimicrobial Susceptibility Profiling
    H. C. Harbottle1 , D. G. White2 , S. Zhao1 , R. D. Walker1 , P. F. McDermott1 , 1FDA, CVM, OR, DAFM, Laurel, MD, 2FDA, CVM, OR, Laurel, MD

  124. B-34
    Real Time PCR Detection of 16S rRNA Genes Speeds MPN Enumeration of Foodborne Listeria monocytogenes
    E. C. De Martinis, R. E. Duvall, A. D. Hitchins, CFSAN, FDA, College Park, MD

  125. B-35
    Proteomic Analysis of Lymph Nodes in Female SKH-1 Hairless Mice Following Tattooing
    N. V. Gopee1 , R. D. Edmondson1 , S. Thyparambil1 , R. C. Jones1 , J. T. Taylor1 , W. G. Wamer2 , P. C. Howard1 , 1NCTR, Jefferson, AR, 2CFSAN, College Park, MD

  126. B-36
    Gene Expression Profiles in Tattooed Skin of SKH-1 Hairless Mice
    N. V. Gopee1 , V. G. Desai1 , B. J. Miller1 , J. C. Fuscoe1 , W. Tong1 , H. Fang1 , W. G. Wamer2 , P. C. Howard1 , 1NCTR, Jefferson, AR, 2CFSAN, College Park, MD

  127. B-37
    Quantification of Nanoscale Quantum Dot Fluorescence in Tissues
    P. C. Howard1 , N. V. Gopee1 , A. R. Warbritton2 , N. J. Walker3 , W. W. Yu4 , V. L. Colvin4 , P. Webb1 , R. L. Bronaugh5 , M. E. Kraeling5 , D. W. Roberts1 , 1NCTR, Jefferson, AR, 2Toxicol. Pathology Assoc., Jefferson, AR, 3NIEHS, Research Triangle Park, NC, 4Rice University, Houston, TX, 5CFSAN, Laurel, MD

  128. B-38
    Penetration of Nanoscale Quantum Dots in Dermabraded Mouse Skin
    N. V. Gopee1 , D. W. Roberts1 , P. Webb1 , C. Cozart1 , P. Siitonen1 , A. R. Warbritton2 , N. J. Walker3 , W. W. Yu4 , V. L. Colvin4 , P. C. Howard1 , 1NCTR, Jefferson, AR, 2Toxicol. Pathol. Assoc., Jefferson, AR, 3NIEHS, Research Triangle Park, NC, 4Rice University, Houston, TX

  129. B-39
    Comparison of five methods of sample preparation for the isolation of Salmonella from alfalfa seeds
    A. P. Jacobson, T. S. Hammack, W. H. Andrews, FDA, College Park, MD

  130. B-40
    Pulsed Field Gel Electrophoresis of Enterobacter sakazakii Strains Reveals Extensive Genotypic Diversity
    C. E. Keys, P. Whittaker, F. S. Fry, E. W. Brown, CFSAN, FDA, College Park, MD

  131. B-41
    Single Enzyme Pulsed-Field Gel Electrophoresis is a Poor Evolutionary Indicator in Salmonella
    E. W. Brown, C. E. Keys, CFSAN, FDA, College Park, MD

  132. B-42
    Antimicrobial Resistance Patterns of Salmonella Isolated from FDA Regulated Products During 2005
    C. R. Kiessling1 , M. B. Buen1 , W. M. Kiessling1 , E. W. Laster1 , M. H. Loftis1 , J. N. Sofos2 , 1FDA, 2Colorado State University

  133. B-43
    Involvement of Interleukin-13 Receptor in Development of Glioblastoma Multiforme
    M. Kioi1 , J. Han1 , E. Michishita2 , T. Shimamura1 , R. K. Puri1 , 1CBER, FDA, Bethesda, MD, 2NCI, NIH, Bethesda, MD

  134. B-44
    Preclinical Data to Support Human Studies of Immune Globulin Products
    H.S. Ko, CBER, FDA, Rockville, MD

  135. B-45
    Sunburn Cell Formation in Human Skin Induced by UV-exposure. Is this Process Dose-Rate Dependent?
    A. Kornhauser1 , R. R. Wei1 , J. C. Hubinger2 , C. N. Barton2 , K. Kaidbey3 , S. A. Miller4 , S. G. Coelho5 , J. Z. Beer5 , B. Z. Zmudzka5 , V. J. Hearing6 , Y. Yamaguchi6 , 1FDA, College Park, MD, 2FDA, College Park, MD, 3Ivy Laboratories, PA, 4FDA, Rockville, MD, 5FDA, Rockville, MD, 6NCI, Bethesda, MD

  136. B-46
    In Vitro Percutaneous Absorption of Salicylic Acid in Hairless Mouse and Human Skin
    M. E. Kraeling, R. L. Bronaugh, Office of Cosmetics and Colors, CFSAN, FDA, Laurel, MD

  137. B-47
    Evaluation of Genetic Stability of Chimera WN/DEN4-3'Delta30 the New Candidate of West Nile Vaccine
    M. Laassri1 , A. Pletnev2 , K. M. Chumakov1 , 1CBER, FDA, Rockville, MD, 2NIAID, NIH, Bethesda, MD

  138. B-48
    Residual Total Protein and Total Organic Carbon Levels on Reprocessed Gastrointestinal (GI) Biopsy Forceps
    S. K. Lappalainen, S. V. Gomatam, V. M. Hitchins, FDA, CDRH, Rockville, MD 20850

  139. B-49
    Residual Total Protein and Total Organic Carbon Levels on Reprocessed Bidirectional Steerable Cardiac Ablation Catheters
    S. K. Lappalainen, S. V. Gomatam, V. M. Hitchins, FDA, CDRH, Rockville, MD 20850

  140. B-50
    Combined synthesis of multi-valent conjugate vaccines
    C. H. Lee, W. C. Kuo, CBER, FDA, Rockville, MD

  141. B-51
    In Vitro Protection of Human Endothelial Cells from Adenovirus Vector Toxicity by Activated Protein C.
    J. N. Lozier, F. d'Agnillo, CBER, FDA, Rockville, MD

  142. B-52
    Mild hyperthermic incubation can potentiate the cytotoxicity of exogenous compounds and medical device extracts
    A. D. Lucas, D. Wray-Cahen, R. P. Brown, S. K. Lappalainen, CDRH, FDA Silver Spring MD

  143. B-53
    A Preliminary Limited Study on Detection of Shigella sonnei from Cantaloupe Rinse by Culturing with or without Pre-enrichment, Cell Capture, and Aerobic or Anaerobic Enrichment
    S. M. Madson1 , E. W. Laster1 , M. Z. Thomas1 , K. A. Watts1 , J. N. Sofos2 , 1FDA Denver District Laboratory, Denver, CO 80225, 2Colorado State University, Fort Collins, CO 80523

  144. B-54
    Negligible Risk of Integration of Plasmid-based Vaccines Delivered with Cationic Lipid- and Poloxamer-based Formulations or with Electroporation
    R. K. Mahajan, A. Vilalta, J. Hartikka, T. Martin, D. Jones, V. Bozoukova, D. Rusalov, P. Lalor, K. Hall, M. Sawdey, A. Rolland, D. Kaslow, Vical, Inc.

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

  146. B-56
    Assessing the Potential of Cell Substrates Used for Vaccine Production to Propagate the Agents of Transmissible Spongiform Encephalopathies (TSEs)
    O. A. Maximova1 , I. Bacik1 , K. L. Pomeroy1 , J. Cervenak1 , I. Vasilyeva2 , O. Yakovleva2 , L. Cervenakova2 , P. Piccardo1 , D. M. Asher1 , 1CBER, FDA, Rockville , MD, 2The Jerome Holland Laboratory, American Red Cross, Rockville, MD

  147. B-57
    Comparison of antimicrobial susceptibility profiles among Salmonella spp. recovered from retail poultry, NARMS 2002-2004.
    S. K. Hubert, S. L. Ayers, A. Glenn, E. Hall-Robinson, P. F. McDermott, L. A. Walker, T. Proeschodt, S. Zhao, S. L. Friedman, J. W. Abbott, R. D. Walker, D. G. White, CVM Office of Research, Laurel, MD

  148. B-58
    Ampicillin and Gentamicin Resistance in E. coli from 1950 - 2002
    P. F. McDermott1 , S. K. Hubert1 , J. Tang2 , L. Quesada2 , R. D. Walker1 , 1CVM Office of Research, Laurel, MD, 2American Type Culture Collection, Manassas, VA

  149. B-59
    Utilization of sucrose and D-serine in foodborne Escherichia coli pathogens
    A. Mukherjee, K. L. McCutchan, D. Roberson, J. E. LeClerc, T. A. Cebula, CFSAN, FDA, Laurel, MD

  150. B-60
    Threat Assessment of Potentially Emerging Salmonella Serovars Associated with Roma Tomato Outbreak and Egg Houses in the United States
    E. Job1 , G. Wagley2 , S. F. Al-Khaldi2 , S. L. Foley3 , D. E. Farmer2 , M. O. Walderhaug2 , K. Kerdahi2 , C. E. Cerniglia2 , R. Nayak2 , 1Brigham Young Univ., 2FDA, 3Marshfield Clinic Research Foundation

  151. B-61
    Genotyping of measles virus in clinical specimens based on oligonucleotide microarray hybridization patterns
    A. A. Neverov1 , M. A. Riddell2 , W. J. Moss3 , D. V. Volokhov1 , P. A. Rota4 , L. E. Lowe4 , D. Chibo2 , S. B. Smit5 , D. E. Griffin3 , K. M. Chumakov1 , V. E. Chizhikov1 , 1CBER, FDA, Rockville, MD, 20852, 2Victorian Infectious Diseases Reference Laboratory, Melbourne, Victoria, Australia, 3051, 3Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, 4National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, 5National Institute for Communicable Diseases, Johannesburg, South Africa, 2131

  152. B-62
    The Pathway and Expression of the Fusion Protein Von Willebrand Cleavage Protease ADAMTS13 in Human Cells
    C. E. Allen1 , R. Lieber1 , E. Plum1 , S. Garfield2 , S. Wincovitch2 , J. M. Newell1 , C. Kimchi-Sarfaty1 , 1CBER, FDA, Bethesda, MD, 2NCI, NIH, Bethesda, MD

  153. B-63
    The Effect of Cyclosporine A on ADAMTS13 Metalloprotease
    J. M. Newell1 , C. E. Allen1 , A. M. Calcagno2 , Z. E. Sauna2 , C. Kimchi-Sarfaty1 , 1CBER, FDA, Bethesda, MD, 2NCI, NIH, Bethesda, MD

  154. B-64
    Deaths due to transfusion-transmitted Klebsiella pneumoniae, 1995-2004
    M. T. Niu, M. Knippen, L. Simmons, L. Holness, CBER, FDA, Rockville, MD

  155. B-65
    Comparison of 3M Petrifilm Environmental Listeria Plates with Selective Enrichment Methods for the Detection and Recovery of Listeria monocytogenes on Environmental Surfaces.
    J. E. Groves, D. G. Nyachuba, C. W. Donnelly, Department of Nutrition & Food Sciences, University of Vermont, Burlington, VT 05405

  156. B-66
    Development of human cell based safety evaluation assay for N. meningitidis Group B non-capsular vaccines.
    M. Paul-Satyaseela, S. Gudlavalleti, M. S. Blake, C. E. Frasch, M. C. Bash, CBER, FDA, Rockville, MD USA

  157. B-67
    Studies on SV40: Development of Neutralization Assays for Primate Polyomaviruses and the Isolation of New Strains of SV40
    L. Sheng, R. Omeir, M. Yacobucci, M. Klutch, A. Pal, A. Lewis, K. Peden, CBER, FDA, Bethesda, MD

  158. B-68
    Translational Control of the SARS Coronavirus
    E. P. Plant1 , J. D. Dinman2 , D. R. Taylor1 , 1CBER, Office of Blood Research and Review, FDA, Bethesda, MD, 2CBMG, University of Maryland, College Park, MD

  159. B-69
    WEST NILE VIRUS ADHERES TO HUMAN RED BLOOD CELLS (RBC) IN WHOLE BLOOD.
    M. Rios1 , S. Daniel1 , S. L. Stramer2 , I. K. Hewlett1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2American Red Cross, Gaithersburg, MD

  160. B-70
    WEST NILE VIRUS NAT-POSITIVE HUMAN PLASMA CONTAINING WNV-IgM AND IgG ANTIBODIES CAN INFECT VERO CELLS AND HUMAN PRIMARY MACROPHAGES IN CULTURE.
    M. Rios1 , S. Daniel1 , S. L. Stramer2 , S. Caglioti3 , O. Wood1 , I. K. Hewlett1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2American Red Cross, Gaithersburg, MD, 3Blood Systems Laboratory, Tampe, AZ

  161. B-71
    Genetic Variability in West Nile Virus (WNV) Isolates From Blood Donors Specimens From 2002 - 2005 USA Epidemics
    A. Grinev1 , S. Daniel1 , S. L. Stramer2 , S. Caglioti3 , I. K. Hewlett1 , M. Rios1 , 1LMV/DETTD/OBRR/CBER/FDA, Rockville, MD, 2American Red Cross, Gaithersburg, MD, 3Blood Systems Laboratories, Tempe, AZ

  162. B-72
    Histopathological Effects of Acute Toxicity of Colchicine (COL) and Lipopolysaccharide (LPS) in Young Adult Rats.
    M. G. Robl1 , P. L. Wiesenfeld1 , L. H. Garthoff1 , T. J. Sobotka1 , J. K. Suagee2 , 1OARSA, CFSAN, FDA, Laurel, MD, 2University, of Maryland, College Park, MD

  163. B-73
    Application of OECD Guideline 425 (UP and Down Procedure) to Establish Dose Range for Toxicity Study
    M. G. Robl1 , P. L. Wiesenfeld1 , L. H. Garthoff1 , T. J. Sobotka1 , J. K. Suagee2 , 1OARSA, CFSAN, FDA, Laurel, MD, 2University of Maryland, College Park, MD

  164. B-74
    Toxicity of oral colchicine (COL) in young adult male and female rats: interactions of vehicle matrix and pre-exposure to lipopolysaccharide (LPS)
    P. L. Wiesenfeld1 , L. H. Garthoff1 , T. J. Sobotka1 , J. K. Suagee2 , C. N. Barton3 , 1OARSA, CFSAN, FDA, Laurel, MD, 2University of Maryland, College Park, MD, 3OSAS, CFSAN, FDA, College Park, MD

  165. B-75
    Description of aw milk-associated illnesses in the United States reported to the U.S. Food and Drug Administration (FDA), 2000-2005.
    M. Ross, C. Leonard, K. C. Klontz, J. Sanders, J. Sheehan, R. Childers, D. Street, CFSAN, FDA, College PArk

  166. B-76
    Moving to molecular biology-based pre-clinical vaccine safety testing: Understanding the viral genetics of mumps virus neurovirulence
    C. J. Sauder1 , C. X. Zhang1 , K. M. Vandenburgh1 , P. Duprex2 , K. M. Carbone1 , S. A. Rubin1 , 1FDA, Bethesda, MD, 2The Queen's University of Belfast, Belfast, UK

  167. B-77
    RNA interference in Trypanosome: A tool to study pathogenesis in Leishmania
    A. Selvapandiyan1 , P. Kumar2 , J. C. Morris3 , C. C. Wang2 , H. L. Nakhasi1 , 1CBER, FDA, Bethesda, MD, 2UCSF, San Francisco, CA, 3Clemson University, Clemson, SC

  168. B-78
    A NEW ANTIVIRAL PATHWAY THAT MEDIATES HCV REPLICON INTERFERON SENSITIVITY THROUGH ADAR1
    D. R. Taylor1 , M. Puig2 , K. Mihalik3 , E. M. Silberstein1 , S. M. Feinstone3 , 1DETTD, CBER, FDA, Rockville, MD, 2DTP, CDER, FDA, Rockville, MD, 3DVP, CBER, FDA, Rockville, MD

  169. B-79
    Development of Plasmid DNA Vaccines Against Highly Pathogenic H5N1 Avian Influenza Viruses
    L. Smith, G. Jimenez, A. Geall, P. Lalor, R. Vahle, R. Planchon, Q. Wei, D. Rusalov, A. Rolland, D. Kaslow, Vical Incorporated

  170. B-80
    The adenoviral fiber shaft is a major determinant of Kupffer cell necrosis
    J. S. Smith1 , S. C. Stevenson2 , J. Tian1 , A. P. Byrnes1 , 1CBER, FDA, Bethesda, MD, 2Department of Diabetes and Metabolism, Novartis Institutes of Biomedical Research Inc., Cambridge, MA

  171. B-81
    Acute Toxicity of Sodium Arsenite in a Complex Food Matrix
    R. L. Sprando1 , T. F. Collins1 , T. N. Black1 , N. Olejnik1 , M. Ramos-Valle1 , J. I. Rorie1 , D. I. Ruggles2 , 1CFSAN,FDA, Beltsville, MD, 2CFSAN,FDA, College Park,MD

  172. B-82
    The rubella virus nonstructural protease recognizes itself via an internal sequence present upstream of the cleavage site for trans-activity
    H. H. Chen, C. J. Stark, C. D. Atreya, DVP, CBER, FDA, Bethesda, MD

  173. B-83
    Prevalence and Antimicrobial Resistance of Campylobacter Isolated from Retail Meat and Poultry, NARMS 2004
    A. A. Stearns, L. L. English, D. G. White, P. F. McDermott, A. Walker, S. K. Hubert, S. L. Ayers, E. Hall-Robinson, T. Prescholdt, R. D. Walker, FDA, Laurel, MD

  174. B-84
    Development of a Nanoparticle-Based Bio-Bar Code Amplification (BCA)Assay for Rapid and Sensitive Detection of HIV-1 RNA and Capsid Protein (p24)
    S. Tang1 , J. Zhao1 , J. J. Storhoff2 , A. Dhar1 , T. Patno2 , C. A. Mirkin3 , S. Wolinsky4 , I. K. Hewlett1 , 1CBER, FDA, Bethesda, MD, 2Nanosphere Inc., Northbrook, IL, 3Northwestern Uni., Evanstone, IL, 4Northwestern Uni., Chicago, IL

  175. B-85
    Evaluation of Nanomaterials' Immunotoxicity: Example of Polystyrene Nanoparticles
    V. J. Tomazic-Jezic, T. H. Umbreit, M. E. Stratmeyer, FDA, CDRH, White Oak, MD

  176. B-86
    Recovery of Listeria monocytogenes from Environmental Swabs
    L. Zhu1 , D. Stewart2 , S. Ravishankar1 , M. Tortorello2 , 1National Center for Food Safety and Technology, Summit IL, 2FDA-CFSAN, Moffett Center, Summit IL

  177. B-87
    The identification of antibacterial compounds for the development of enhanced media for the detection of foodborne fungi
    V. H. Tournas1 , J. S. Kohn2 , E. J. Katsoudas2 , 1CFSAN, FDA, College Park, MD, 2NERL, FDA, Jamaica, NY

  178. B-88
    Moulds, yeasts and aerobic plate counts in medicinal herbal teas and coffee substitutes
    V. H. Tournas1 , E. J. Katsoudas2 , 1CFSAN, FDA, College Park, MD, 2NERL, FDA, Jamaica, NY

  179. B-89
    Enhancement of Salmonella Enteritidis isolation from shell eggs using Ferroxiamine E
    I. E. Valentin-Bon1 , K. H. Seo2 , R. E. Brackett2 , 1USPHS, DHHS, FDA, 2CFSAN, FDA

  180. B-90
    Medicinal Chemistry of Uncaria tomentosa, Lepidium meyenii, and Croton lechleri
    L. G. Valerio, Jr.1 , G. F. Gonzales2 , 1Office of Food Additive Safety, CFSAN, FDA, College Park, MD, 2Department of Biological and Physiological Sciences, Universidad Peruana Cayetano Heredia, Lima, Peru

  181. B-91
    Genetic markers of Mollicutes: The use of the 16S-23S rRNA intergenic transcribed spacer (ITS) region for detection of mycoplasma contamination and identification.
    D. V. Volokhov, J. George, A. A. Neverov, H. Kong, D. Chandler, C. Anderson, V. E. Chizhikov, FDA, Rockville, MD

  182. B-92
    The Hairless Guinea Pig as an Animal Model for Identifying Indirect Photosensitizers
    W. G. Wamer, P. K. Fu, R. R. Wei, J. C. Hubinger, CFSAN, FDA, College Park, MD

  183. B-93
    PROTECTIVE EFFECT OF MIDAZOLAM ON KETAMINE-INDUCED NEUROTOXICITY IN RAT FOREBRAIN CULTURE
    C. Wang1 , N. Sadovova2 , C. X. Zou1 , A. C. Scallet1 , T. A. Patterson1 , J. P. Hanig3 , M. G. Paule1 , W. Slikker1 , 1NCTR, FDA, Jefferson, AR, 2Toxicologic Pathology Associates, Jefferson, AR, 3CDER, FDA, Rockville, MD

  184. Sigma Xi Winning Poster Ribbon iconB-94
    Antimicrobial Resistance among E. coli Isolates Recovered from Retail Foods of Animal Origin, NARMS 2004
    D. G. White1 , S. L. Ayers1 , A. Glenn1 , E. Hall-Robinson1 , R. D. Walker1 , T. M. Chiller2 , P. F. McDermott1 , 1CVM, FDA, Laurel, MD, 2CDC, Atlanta, GA

  185. B-95
    VEGF and anti-restenotic drugs induce a prothrombotic state in endothelial cells.
    S. C. Wood1 , G. S. Bushar1 , B. Tesfamariam2 , 1CDRH, Silver Spring, MD, 2CDER, Silver Spring, MD

  186. B-96
    Percutaneous Absorption of Retinol in Fuzzy Rat (In Vivo and In Vitro) and Human Skin (In Vitro) From Cosmetic Vehicles
    J. J. Yourick1 , C. T. Jung2 , R. L. Bronaugh1 , 1Office of Cosmetics and Colors, CFSAN, FDA, Laurel, MD, 2OPS/OGD/DBE, CDER

  187. B-97
    NITRIC OXIDE-ASSOCIATED NEPHROTTOXICITY IN JUVENILE RATS TREATED WITH GENTAMICIN
    J. Zhang1 , T. J. Miller1 , N. P. Clayton2 , J. P. Hanig1 , P. Espandiari1 , 1CDER, FDA, Silver Spring, MD, 2NIEHS, Research Triangle Park, NC

  188. B-98
    A PROINFLAMMATORY ROLE OF MAST CELL DEGRANULATION (MCD) IN DRUG-INDUCED VASCULAR INJURY IN SPRAGUE-DAWLEY RATS
    J. Zhang1 , A. D. Knapton1 , T. J. Miller1 , P. Espandiari1 , R. Anderson1 , E. H. Herman1 , R. Snyder2 , J. P. Hanig1 , J. L. Weaver1 , 1CDER, FDA, Silver Spring, MD, 2Schering-Plough Research Institute, Lafayette, NJ

  189. B-99
    Characterization Salmonella enterica serovar Heidelberg from Retail Meat Samples: National Antimicrobial Resistance Monitoring System (NARMS): 2002-2004
    S. Zhao, D. G. White, S. F. Friedman, A. Glenn, S. L. Ayers, J. W. Abbott, S. K. Hubert, E. Hall-Robinson, H. C. Harbottle, R. D. Walker, P. F. McDermott, CVM, FDA, Laurel, MD

  190. B-100
    Characterization of Antimicrobial Resistance of Salmonella Isolates Recovered From Diseased Animals
    S. Zhao1 , P. F. McDermott1 , D. G. White1 , S. Qaiyumi1 , S. F. Friedman1 , J. W. Abbott1 , A. Glenn1 , S. L. Ayers1 , P. K. Post2 , W. H. Fales3 , R. B. Wilson4 , C. Reggiardo5 , R. D. Walker1 , 1CVM, FDA, Laurel, MD, 2Rollins Animal Disease Diagnostic Laboratory, Raleigh, NC, 3University of Missouri, VMDA, Columbia, MO, 4CE Kord Animal Laboratory, Tennessee Department of Agriculture, Nashville, TN, 5Arizona Veterinary Diagnostic Laboratory, University of Arizona, Tucson, AZ

  191. B-PO-101
    Interactive cytotoxicity of phthalate monoesters in Jurkat lymphoma cells
    A. D. Lucas, R. P. Brown, M. E. Stratmeyer, CDRH, FDA, Silver Spring, MD

  192. B-PO-102
    A Simple and Rapid Clinical Observational Battery (COB) for Predicting Mortality in a Small Rodent Model with Potential Application to Counter-terrorism.
    J. K. Suagee1 , L. H. Garthoff1 , P. L. Wiesenfeld1 , T. J. Sobotka1 , C. N. Barton2 , 1OARSA, FDA, Muirkirk Road Complex, Laurel, MD, 2OSAS, FDA, College Park, MD

  193. B-PO-103
    Solar UV doses of young Americans are inadequate for sufficient vitamin D3 production
    D. E. Godar1 , S. G. Coelho1 , W. B. Grant2 , M. F. Holick3 , 1CDRH, FDA, Rockville, MD, 2Sunlight, Nutrition and Health Research Center, SUNARC, San Francisco, CA 94109, 3Department of Medicine, Boston University School of Medicine, Boston, MA 02118

  194. B-PO-104
    Solar UV doses of adult Americans are inadequate for sufficient vitamin D3 production
    D. E. Godar1 , W. B. Grant2 , M. F. Holick3 , 1CDRH, FDA, Rockville, MD, 2Sunlight, Nutrition and Health Research Center, SUNARC, San Francisco, CA 94109, 3Department of Medicine, Boston University School of Medicine, Boston, MA 02118

  195. B-PO-105
    Campylobacter jejuni Induce Maturation and Cytokine Production in Human Dendritic Cells
    L. Hu, M. D. Bray, M. Osorio, D. J. Kopecko, LESTD, CBER, FDA, Bethesda, MD 20892

  196. B-PO-106
    Development of a Real Time PCR Method for the Detection of Yersinia enterocolitica in Green Leafy Vegetables
    A. Rodriguez1 , A. Margolin2 , 1WEAC, Winchester, MA, 2UNH, Durham, NH

  197. B-PO-107
    Evaluation of efficacy of quaternary ammonium compounds as disinfectant to inactive Enterobacter sakazakii - Preliminary Study
    K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD

  198. B-PO-108
    Inactivation of Enterobacter sakazakii vegetative cell to sodium hypochlorite and comparison of biofilm formation on various different conveyor belt chips
    K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD

  199. B-PO-109
    Multi-detection system for E. coli O157:H7 and Salmonella Enteritidis using by quantum dots as nanotechnology -Preliminary Study
    K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD

  200. B-PO-110
    Removal and inactivation of Bacillus anthracis spores using by various commercial disinfectants
    K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD

  201. B-PO-111
    Comparison of FDA method and Real-Time PCR for the detection of Enterobacter sakazakii in powdered infant formula- Preliminary Study
    K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD

  202. B-PO-112
    Comparison of Ct value on 10 different pre-enrichment broths to detect Enterobacter sakazakii in powdered infant formula using by Real-Time PCR- Preliminary Study
    K. Y. Song1 , K. H. Seo2 , S. Lee1 , R. E. Brackett2 , 1JIFSAN, UMD, College Park, MD, 2CFSAN, FDA, College Park, MD

  203. B-PO-113
    Devolutionary-like Changes in the Genome of a Natural Atypically Hemolytic Listeria innocua Strain Suggesting a Common Ancestor of L. monocytogenes and L. innocua.
    D. V. Volokhov1 , S. Duperrier2 , A. A. Neverov1 , J. George1 , R. E. Duvall3 , C. Buchrieser2 , A. D. Hitchins3 , 1FDA, Rockville, MD, 2Institut Pasteur, Paris, France, 3FDA, College Park, MD

  204. B-114
    Enterobacter sakazakii Detection During Routine Bacteriological Examination of Food Samples
    M. O. Paul, NRL, ORA, FDA

    205. CATEGORY C: BIOLOGICAL ENDPOINTS, BIOMARKERS, SURROGATE MARKERS, AND IMAGING TECHNOLOGIES
    Menu

  205. C-01
    NMR AND MS METABOLIC PROFILES OF LIPIDS IN PLASMA FROM HUMAN PANCREATIC CANCER AND CONTROL PATIENTS
    R. D. Beger1 , L. K. Schnackenberg1 , R. D. Holland1 , D. Li2 , Y. P. Dragan1 , 1NCTR, FDA, Jefferson, AR, 2University of Texas, MD Anderson Cancer Center, Houston, TX

  206. C-02
    A data-based assessment of alternative strategies for identification of potential human cancer hazards
    A. R. Boobis1 , D. Jacobson-Kram2 , J. S. MacDonald3 , N. G. Doerrer4 , 1Imperial College London, London, UK, 2CDER, FDA, Silver Spring, MD, 3Schering-Plough Research Institute, Kenilworth, NJ, 4ILSI Health and Environmental Sciences Institute, Washington, DC

  207. C-03
    Biomarkers of early kidney injury: Kidney injury molecule-1 (Kim-1) expression in kidney and urine after acute exposure to gentamicin or mercury
    P. L. Goering1 , V. S. Vaidya2 , R. P. Brown1 , Z. Vakili1 , B. A. Rosenzweig3 , A. M. Johnson2 , K. L. Thompson3 , A. I. Steen1 , J. V. Bonventre2 , 1CDRH, FDA, Rockville, MD, 2Harvard Medical School, Boston, MA, 3CDER, FDA, Silver Spring, MD

  208. C-04
    Preliminary Evaluation of an Early Surrogate Marker for Successful Laser Treatment in Ovine Hyaluronidase-Treated Subjects with Diabetes and Severe Vitreous Hemorrhage
    E. Thomas1 , L. R. Grillone2 , T. R. McNamara2 , J. A. Gow2 , A. M. Hochberg3 , R. K. Pearson3 , 1L.A. Retina, Beverly Hills, CA, 2ISTA Pharmaceuticals®, Inc., Irvine, CA, 3ProSanos Corporation, Harrisburg, PA

  209. C-05
    Examination of the Female Sprague-Dawley Rat as a model of Rosiglitazone-Induced Toxicity
    E. Herman1 , A. D. Knapton1 , T. Miller1 , P. Espandiari1 , R. Anderson1 , S. Moore2 , J. P. Hanig1 , 1OPS/OTR/DAPR, 2Ciphergen Biosystems, Inc

  210. C-06
    Cdc42 as a potential therapeutic target for the reduction of cellular proliferation and migration in EGFR overexpressing breast cancer cells
    D. S. Hirsch, Y. Shen, W. J. Wu, DMA, OBP/OPS, CDER, FDA

  211. C-07
    Progress in Developing Imaging Biomarkers for Parkinson's Disease (PD)
    C. S. John, Y. M. Choi, G. Q. Mills, CDER, FDA

  212. C-08
    Role of Interleukin-4/13 Receptors as Potential Biomarkers of Disease in Human Bladder carcinoma in situ
    B. H. Joshi, P. Leland, F. Varricchio, S. R. Husain, R. K. Puri, CBER, FDA, Bethesda, MD

  213. C-09
    Differential Effect of Collagen and Alginate Gels on Chondrocyte Growth and Phenotype Expression
    D. S. Kaplan1 , V. M. Hitchins1 , P. V. Phan2 , R. Y. Au2 , M. W. Hungerford3 , C. G. Frondoza3 , 1CDRH, FDA, Rockville, MD 20850, 2Nutramax Laboratories, Edgewood, MD, 3Johns Hopkins Univ., Dept. Orthopaedic Surgery, Good Samaritan Hosp., Baltimore, MD

  214. C-10
    IN-SITU PERFUSION OF RAT MESENTERY WITH DRUGS TO EVALUATE ROLE OF MAST CELL DEGRANUALTION IN EARLY MESENTERIC VASCULAR INFLAMMATION.
    A. D. Knapton1 , J. Zhang1 , J. L. Weaver1 , F. D. Sistare2 , J. P. Hanig1 , 1FDA, Silver Spring, MD, 2Merck, West Point, PA

  215. C-11
    Screening for Malarial Antibodies as a Criterion to Guide Donor Deferral Policy for Malaria Risk
    S. Kumar1 , V. Majam1 , H. Zheng1 , B. Mahajan1 , M. Parise2 , M. Wilson2 , 1CBER, FDA, Rockville, MD, 2CDC, Atlanta, GA

  216. C-12
    Transplacental and postnatal exposure to aids drugs zidovudine (AZT) and lamivudine (3TC) increases lymphoma incidence in C3B6-trp53tm1Brd[N12]F1 transgenic mice.
    J. E. Leakey1 , F. W. Lee1 , S. M. Lewis1 , G. Olson2 , J. K. Dunnick3 , W. T. Allaben1 , 1OSC, 2TPA, 3900 NCTR Rd, Jefferson, AR 72079, 3NIEHS, POB 12233, Research Triangle Park, NC 27709

  217. C-13
    Detection of the C to T Polymorphism in DNA-Methyl-transferase-3B (DNMT3B) Promoter Correlates with Expression of DNMT 3B in Female Pancreatic Tumor Cells: Modulation of Expression by Indole-3-Carbinol and Gemcitabine.
    B. D. Lyn-Cook1 , A. Haefele2 , B. Word1 , G. J. Hammons1 , 1FDA, 2University of Arkansas at Little Rock

  218. C-14
    An operational FDG/PET-CT protocol for drug development in oncology
    R. P. Maguire1 , W. A. Hallett2 , 1Pfizer Global R&D, Groton, USA, 2GlaxoSmithKline, London, UK

  219. C-15
    Cytochrome c: A Non-Invasive Biomarker Of Drug-Induced Liver Toxicity
    T. J. Miller, P. Espandiari, J. Zhang, A. D. Knapton, J. Weaver, E. Herman, J. P. Hanig, CDER, FDA, Silver Spring, MD

  220. C-16
    Optical Properties of Nanoshells for Diagnostic Imaging
    A. Agrawal, J. Pfefer, CDRH, FDA, Rockville, MD

  221. C-17
    The Role of CDc42 in the Development of Human Breast Cancer
    Y. Shen, D. S. Hirsch, W. J. Wu, OBP, DMA, CDER, FDA

  222. C-18
    Fluorescence Imaging of Metastasis of Human Pancreatic Carcinoma in a Xenograft Model and Prolongation of Survival of Animals when Treated with IL-4 Receptor-directed Cytotoxin
    T. Shimamura1 , R. Royal2 , M. Kioi1 , K. Angra1 , S. R. Husain1 , R. K. Puri1 , 1CBER, FDA, Bethesda, MD, 2National Cancer Institute, NIH

  223. C-19
    Risk of Local Adverse Events by Gender Following Cardiac Catheterization
    D. R. Tavris1 , B. A. Gallauresi1 , S. Dey2 , R. Brindis3 , K. Mitchel2 , 1FDA, 2American College of Cardiology, 3San Francisco Kaiser Hospital

  224. C-20
    A Cost-Benefit Approach to the Regulation, Qualification and Acceptance of Biomarkers and Surrogate Endpoints
    S. A. Williams1 , D. E. Slavin1 , J. A. Wagner2 , C. J. Webster3 , 1Pfizer, 2Merck, 3Millenium

  225. C-21
    Use of "DNA Barcoding" to Detect Adulteration of Star Anise (Illicium verum) by Other Illicium Species
    A. Ottesen1 , G. C. Ziobro2 , 1JIFSAN, University of Maryland, College Park, MD, 2CFSAN, FDA, College Park, MD

    CATEGORY D: GENOMICS, PROTEOMICS, PREDICTIVE TOXICOLOGY AND MODELING
    Menu

  226. D-01
    Scientific and Regulatory Challenges of Endocrine Disruptors: Human Food Safety Considerations
    M.C. Aguila, CVM, FDA, Rockville, MD

  227. D-02
    The History of Voluntary Genomic Data Submissions (VGDS) at the U.S. FDA
    F. W. Frueh1 , L. J. Lesko1 , A. Rudman1 , F. Goodsaid1 , S. Amur1 , J. Woodcock2 , 1CDER, FDA, White Oak, MD, 2FDA, Rockville, MD

  228. Sigma Xi Winning Poster Ribbon iconD-03
    Assessment of differential gene expression in peripheral blood mononuclear cells (PBMCs) during drug treatment in cancer patients - A Voluntary Genomic Data Submission (VGDS) Study
    S. Amur1 , A. Noory1 , W. Tong2 , F. Goodsaid1 , F. W. Frueh1 , 1CDER, FDA, White Oak, MD, 2NCTR, FDA, Little Rock, AK

  229. D-04
    Genomic Biomarkers in FDA-approved drug labels
    P. Mummaneni, S. Amur, F. Goodsaid, A. Rudman, F. W. Frueh, CDER, FDA, White Oak, MD

  230. D-05
    Pharmacogenomic Information in Drug Labels: Using a Relational Database to Integrate Genetic and Genomic Information with Chemical, Biochemical, and Clinical Information
    S. Amur1 , A. Rudman1 , P. Mummaneni1 , D. Bagatto2 , J. Gut2 , F. W. Frueh1 , 1CDER, FDA, White Oak, MD, 2Theragenomics Associates

  231. D-06
    A Proteomic Analysis of the Thermoregulation of Shigella Virulence Factors
    R. L. Bell, T. L. Williams, D. Andrezjewski, K. A. Lampel, S. M. Musser, CFSAN, FDA, College Park, MD

  232. D-07
    Free fatty acids (FFA) changes correlate with brain genomic and metabonomic markers of the 3-NPA-induced mitochondrial stress in the rat brain
    Z. K. Binienda1 , B. T. Thorn2 , L. K. Schnackenberg1 , R. D. Beger1 , P. P. Sapienza3 , C. S. Kim3 , S. F. Ali1 , B. D. Przybyla4 , 1NCTR, FDA, Jefferson, AR, 2Z-Tech, Co., Jefferson, AR, 3CFSAN, FDA, Laurel, MD, 4UAMS, Little Rock, AR

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

  234. D-09
    Prioritizing sources of variability in genomic microarray data (OSHC inter-center project)
    D. G. Ranamukhaarachchi1 , D. Nandanie1 , R. Puri2 , A. X. Yang2 , J. Han2 , J. C. Fuscoe3 , T. Han3 , W. S. Branham3 , H. F. Yancy4 , H. C. Harbottle4 , J. Mason5 , S. Morris3 , W. Liggett6 , S. J. Wang7 , D. Mendrick8 , T. Martinsky9 , 1CDRH, Federal Labs at White Oak, Silver Spring MD, 2CBER, FDA, Bethesda MD, 3NCTR, FDA, Jefferson AR, 4CVM, FDA, Laurel MD, 5Howard U. Washington DC, 6CDRH/NIST, FDA, Rockville MD, 7CDER, Federal Labs at White Oak, Silver Spring MD, 8GeneLogic, 9Telechem

  235. D-10
    The National Center for Toxicological Research. ...research innovations for public health
    T. J. Flammang, J. F. Anson, W. Slikker, NCTR, Jefferson, AR

  236. D-11
    2D and 3D QSAR Models for Prediction of hERG K+ Channel Inhibition
    G. Fraczkiewicz, D. Zhuang, R. Fraczkiewicz, W. S. Woltosz, M. B. Bolger, Simulations Plus, Inc., Lancaster, CA

  237. D-12
    New empirical method obtains partial atomic charges from 2D inputs and improves some predictive ADMET models
    R. Fraczkiewicz, G. Fraczkiewicz, M. B. Bolger, W. S. Woltosz, Simulations Plus, Inc.; 42505 10th Street West, Lancaster, CA 93534

  238. D-13
    Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model (OWH Project)
    J. C. Fuscoe1 , R. D. Beger1 , W. S. Branham1 , R. R. Delongchamp2 , Y. P. Dragan1 , P. H. Duffy3 , R. D. Edmondson1 , T. Han1 , D. K. Hansen3 , R. D. Holland1 , R. C. Jones1 , C. L. Moland1 , L. K. Schnackenberg1 , J. T. Taylor1 , W. Tong1 , 1Division of Systems Toxicology, NCTR, FDA, Jefferson, AR, 2Division of Biometry and Risk Assessment, NCTR, FDA, Jefferson, AR, 3Division of Genetic and Reproductive Toxicology, NCTR, FDA, Jefferson, AR

  239. D-14
    Quality Prediction of Cell Substrate Using Gene Expression Profiling
    J. Han1 , R. L. Farnsworth2 , J. L. Tiwari1 , J. Tian1 , H. Lee1 , P. Ikonomi2 , A. P. Byrnes1 , J. L. Goodman1 , R. K. Puri1 , 1CBER, FDA, Bethesda, MD, 2ATCC, Manassas, VA

  240. D-15
    Optimization of hybridization and washing conditions to improve the reproducibility and accuracy of DNA microarray quantification
    T. Han, C. D. Melvin, L. Shi, W. S. Branham, P. S. Pine, K. L. Thompson, J. C. Fuscoe, FDA

  241. D-16
    Drug-metabolizing enzymes: Evidence for clinical utility of pharmacogenomic tests
    T. Andersson1 , D. A. Flockhart2 , D. B. Goldstein3 , S. M. Huang4 , D. L. Kroetz5 , P. M. Milos6 , M. J. Ratain7 , K. Thummel8 , 1AstraZeneca, 2Indiana University, 3Duke University, 4CDER, FDA, Silver Spring, MD, 5UCSF, 6Pfizer, 7University of Chicago, 8University of Washington

  242. D-17
    Insights into the mutator phenotype: Global gene expression in MMR-defective Salmonella enterica using DNA microarrays
    I. R. Patel, S. A. Jackson, J. E. LeClerc, T. A. Cebula, CFSAN, FDA, Laurel, MD

  243. D-18
    A tiling DNA microarray designed to identify and discriminate among individual isolates of Escherichia coli: Applications for array-based MLST and novel SNP discovery
    S. A. Jackson, I. R. Patel, M. K. Mammel, J. E. LeClerc, T. A. Cebula, CFSAN, FDA, Laurel, MD

  244. D-19
    Microarray based detection and identification of foodborne viruses
    B. B. Goswami, M. Ayodeji, M. Kulka, T. A. Cebula, S. A. Jackson, I. R. Patel, M. Mammel, D. Ngo, CFSAN, OARSA, FDA, Laurel, MD

  245. D-20
    Optical mapping whole chromosomes of E. coli O157:H7 reveals large chromosomal inversions and genome differences at prophage sites: Implications for individual strain identification
    M. L. Kotewicz1 , S. A. Jackson1 , W. Jiang2 , J. Henkhaus2 , A. Briska2 , C. W. Dykes2 , J. E. LeClerc1 , T. A. Cebula1 , 1CFSAN, FDA, Laurel MD, 2OpGen Inc. Madison WI

  246. D-21
    Genomic comparisons of antibiotic susceptible and resistant Salmonella Newport strains
    M. K. Mammel, J. E. LeClerc, T. A. Cebula, DMB, OARSA, CFSAN, FDA, Laurel, MD

  247. D-22
    Development of a QSAR Weight of Evidence Model for Reproductive and Developmental Toxicity Hazard Identification
    E. J. Matthews, N. L. Kruhlak, R. D. Benz, J. F. Contrera, CDER, FDA, Silver Spring, MD

  248. D-23
    Structure Activity Relationship Analysis Tools: Validation and Applicability
    J. Mayer, M. Cheeseman, M. L. Twaroski, CFSAN, FDA, College Park, MD

  249. D-24
    Importance of Data Filtration in the Analysis of Voluntary Genomic Data Submission (VGDS) data - An Example
    A. Y. Men, S. Amur, F. Goodsaid, F. W. Frueh, CDER, FDA, Silver Spring, MD

  250. D-25
    Development of Microarray Standards and Procedures for Analyzing Clinical Samples
    A. D. Nandanie1 , S. Lababidi2 , R. K. Panguluri1 , M. Schneider1 , D. G. Ranamukhaarachchi1 , 1DB, OSEL, CDRH, FDA, 2DB, OSB, CDRH, FDA

  251. D-26
    Metabonomics Applied to a Rodent Pediatric Nephrotoxicity Model
    L. K. Schnackenberg1 , P. Espandiari2 , J. Zhang2 , P. S. Pine2 , R. Anderson2 , R. D. Beger1 , J. P. Hanig2 , 1NCTR, FDA, Jefferson, AR, 2CDER, FDA, Silver Spring, MD

  252. D-27
    Oligo Design: Software for DNA Sequence Analysis including PCR Primer and Microarray Probe Design
    N. Sergeev1 , A. Rasooly2 , K. Herold3 , 1FDA/CDRH/OSEL/DB, Silver Spring, MD, 2NIH-National Cancer Institute, Rockville, MD, 3UMD- University of Maryland, College Park, MD

  253. D-28
    Molecular Characterization of the Canine Factor VIII Gene and Duplicated Sequences Related to a Common Gene Inversion Mutation
    N. Tayebi, L. Wood, J. N. Lozier, CBER, FDA, Rockville, MD

  254. D-30
    Characterization of Alterations in Rat Liver Microarray Data Induced by Tissue Handling
    P. S. Pine1 , B. A. Rosenzweig1 , Y. Turpaz2 , K. L. Thompson1 , 1CDER, FDA, Silver Spring, MD 20993, 2Affymetrix Inc., Santa Clara, CA 95051

  255. D-31
    Evaluation of the Age-Dependent Nephrotoxicity of Gentamicin Using Gene Expression Biomarkers.
    B. A. Rosenzweig, K. L. Thompson, J. Zhang, J. P. Hanig, P. Espandiari, CDER, FDA, Silver Spring, MD 20993

  256. D-32
    The Global Ratio as a Quality Control Metric for Microarray Data
    C. Alvares1 , M. A. Kuziora1 , P. S. Pine2 , K. L. Thompson2 , 1Gene Logic, Gaithersburg, MD 20879, 2CDER, FDA, Silver Spring, MD 20993

  257. D-33
    A Baseline Animal Microarray Database for Biological Response Identification and Biomarker Validation
    J. Fostel1 , K. L. Thompson2 , M. Cooper3 , S. Pettit4 , 1NCT, NIEHS ITSS, Research Triangle Park, NC, 2CDER, FDA, Silver Spring, MD, 3Biogen Idec, Cambridge, MA, 4HESI, Washington, DC

  258. D-34
    Genetic Associations in Clinical Trials: Some Issues in Design and Analysis
    J. L. Tiwari, R. K. Puri, B. Zaslavsky, CBER, FDA, Rockville, MD

  259. D-35
    NCTR Center for Toxicoinformatics - A Bioinformatics Resource for Genomics, Proteomics, Metabolomics and Predictive Toxicology
    W. Tong1 , L. Shi1 , S. Harris1 , M. Bishop1 , H. Fang2 , H. Hong2 , Q. Xie2 , H. Sun2 , M. Cao2 , F. Ranamukhaarachchi2 , R. Perkins2 , 1NCTR, FDA, 2Z-tech

  260. D-36
    Comparison of Artificial Neural Network and Support Vector Machine Ensemble Models
    D. Zhuang, R. Fraczkiewicz, W. S. Woltosz, M. B. Bolger, Simulations Plus Inc., 42505 10th Street West, Lancaster, CA, 93534

  261. D-38
    Sex Differences in CYP3A Activity Using Intravenous and Oral Midazolam
    M. Chen, L. Ma, G. L. Drusano, J. S. Bertino, Jr., A. N. Nafziger, Ordway Research Institute, Albany, NY 12208

  262. D-PO-37
    The E. coli lac operon: Why?
    R.L. Bernstein, FDA, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070

    CATEGORY E: IPREDICTIVE PHARMACOKINETICS AND PHARMACODYNAMICS
    Menu

  263. E-01
    Effect of a Potent CYP3A Inhibitor Ketoconazole on Interindividual Variability of CYP3A Activity as Measured by Oral Midazolam
    M. Chen, A. N. Nafziger, J. S. Bertino, Jr., Ordway Research Institute Drug Development Center, Ordway Research Institute, Albany, NY 12208

  264. E-02
    Exposure-Response Relationship for an Anti-Infective in an Animal Infection Model versus Patients
    C. R. Bonapace1 , V. R. Jarugula1 , B. Green2 , J. V. Gobburu1 , 1CDER, FDA, Silver Spring, MD, 2School of Pharmacy, University of Queensland, Brisbane, Australia

  265. E-03
    Excel and Visual Basic software can be used to develop a physiologically-based pharmacokinetic (PBPK) model for ethylene oxide
    K. Herold1 , R. P. Brown2 , M. E. Stratmeyer2 , 1University of Maryland, College Park, MD, 2CDRH, FDA, Silver Spring, MD

  266. E-04
    Comparison of Bovine In Vivo Bioavailability of Two Sulfamethazine Oral Boluses Exhibiting Different In Vitro Dissolution Profiles.
    M. N. Martinez1 , J. C. Kawalek2 , K. D. Howard2 , J. L. Ward2 , P. Marroum3 , W. G. Marnane1 , D. M. Bensley1 , F. R. Pelsor1 , S. W. Hoag4 , A. S. Tatavarti4 , L. Xie4 , R. M. Fahmy1 , 1CVM, FDA, Rockville, MD, 2CVM, OR, Laural, MD, 3CDER, FDA, Silver Spring, MD, 4University of Maryland

  267. E-05
    PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR THE INHIBITION OF MIDAZOLAM CLEARANCE BY ERYTHROMYCIN AND DILTIAZEM
    X. Zhang1 , J. C. Gorski2 , S. M. Huang3 , A. Lucksiri2 , J. Y. Chien4 , S. K. Quinney2 , D. R. Jones2 , S. D. Hall2 , 1Purdue University, West Lafayette, IN, 2Indiana University, Indianapolis IN, 3CDER, FDA, Rockville MD, 4Eli Lilly & Co, Indianapolis IN

  268. E-06
    Simulation of Midazolam Absorption and Bioavailability in Pediatric Patients
    V. Lukacova, W. S. Woltosz, M. B. Bolger, Simulations Plus, Inc., Lancaster, CA

  269. E-07
    Epidemiological cut-off values for four antimicrobial agents against Aeromonas salmonicida isolates using MIC and zone diameter frequency distributions
    R. A. Miller, R. D. Walker, R. Reimschuessel, CVM, FDA, Laurel, MD

  270. E-08
    Pharmacokinetics of Gabapentin Injection in Cerebrospinal Fluid and Plasma with Intrathecal Administration
    R. J. Sawchuk1 , L. M. Page2 , R. L. Rauck3 , 1University of Minnesota, College of Pharmacy, Minneapolis, MN 55455, 2Medtronic Neurological, Minneapolis, MN 55432, 3Carolinas Pain Institute, Winston-Salem, NC 27103

  271. E-09
    Improving Pediatric Dosing Through Pediatric Initiatives - What We Have Learned
    W. J. Rodriguez, A. Selen, D. Avant, C. Chaurasia, T. Crescenzi, G. Gieser, J. DiGiacinto, S. M. Huang, P. Lee, L. Mathis, D. Murphy, S. Murphy, R. Roberts, H. C. Sachs, S. Suarez, V. Tandon, R. S. Uppoor, J.A. Lazor, L.J. Lesko and D. M. Chilukuri, CDRH, FDA

  272. E-10
    Parameter Sensitivity Analysis and Virtual Trial of Oral Cyclosporine Capsule
    P. M. Sathe1 , V. A. Sayeed1 , L. X. Yu1 , M. B. Bolger2 , 1OGD, CDER, FDA, Rockville, MD, 2Simulations Plus Inc, Lancaster, CA

  273. E-11
    Metabolism and residue depletion of [3]H-ivermectn in the muscle tissue of rainbow trout after oral administration
    B. Shaikh, N. G. Rummel, C. Gieseker, R. Reimschuessel, FDA/CVM, Laurel, MD

  274. E-PO-12
    Distribution of Androstenedione and Its Related Steroids in Pregnant Rats
    I. A. Ross, P. P. Sapienza, W. D. Johnson, R. L. Sprando, K. R. O'Neill, S. C. Sahu, T. J. Flynn, T. F. Collins, P. L. Wiesenfeld, C. S. Kim, CFSAN, Laurel, MD

    CATEGORY F: MEDICAL PRODUCT DESIGN, CHARACTERIZATION, AND MANUFACTURING
    Menu

  275. F-01
    STEALTH NANOPARTICLES FOR THE FABRICATION OF DRUG DELIVERY DEVICES
    E. O. Akala, O. Okunola, Howard University, Washington, DC

  276. F-02
    A Multiplex PCR Microarray Assay for Screening Blood
    R. Duncan, C. A. Cadogan, K. Tomioka, A. Selvapandiyan, K. Stabler, J. Mellquist-Riemenschneider, D. V. Volokhov, V. E. Chizhikov, H. L. Nakhasi, CBER, FDA, Bethesda, MD

  277. F-03
    Analysis of Oligomeric Organosilsesquioxanes by MALDI-TOF Mass Spectrometry
    M. Farahani1 , J. M. Antonucci2 , C. M. Guttman2 , W. E. Wallace2 , 1CDER, FDA, Rockville, MD, 2NIST, Gaithersburg, MD

  278. F-04
    Development of a Novel Technology to Measure Impaction Force of Nasal Sprays and Metered-Dose Inhalers Using the Texture Analyser
    C. Guo, W. H. Doub, DPA, CDER, FDA, St. Louis, MO

  279. F-05
    Simple confocal microscopy based on single hollow-core photonic bandgap fiber
    D. H. Kim1 , J. U. Kang1 , R. Waynant2 , I. K. Ilev2 , 1Johns Hopkins University, Baltimore, MD, 2CDRH, FDA, Rockville, MD

  280. F-06
    Characterizing Reflections from Intraocular Lens Implants
    R. J. Landry, I. K. Ilev, T. J. Pfefer, R. W. Faaland, D. Calogero, CDRH, FDA, Rockville, MD

  281. F-07
    Establishment of design space for a modified-release Zidovudine microsphere dosage form
    D. R. Lu1 , K. Abu-Izza2 , 1ONDQA, CDER, FDA, 2University of Georgia

  282. F-08
    A new robotic approach for high-throughput screening of unique Trazodone salts
    D. R. Lu1 , E. C. Ware2 , 1ONDQA, CDER, FDA, 2University of Georgia

  283. F-09
    New lipoprotein mimics as novel nanoscale DNA vaccine delivery carriers
    D. R. Lu1 , F. Alanazi2 , Z. Fu2 , 1ONDQA, CDER, FDA, 2University of Georgia

  284. F-10
    Evaluation of platelet activation in medical devices
    Q. Lu, R. Malinauskas, S. F. Stewart, CDRH, FDA, Rockville, MD

  285. F-11
    Reversal of Chronic Hypotension by Non-Invasive Plantar Stimulation
    G. Madhavan, K. J. McLeod, Clinical Science and Engineering Research Center, State University of New York, Binghamton, New York

  286. F-12
    Optimization of cyclosporine A self-nanoemulsified drug delivery systems using Box-Behnken design and desirability function
    A. S. Zidan1 , M. A. Habib2 , A. NguyenPho3 , M. A. Khan4 , 1DPQR, CDER, FDA, Silver Spring, MD & School of Pharmacy, Howard University, Washington, DC, 2School of Pharmacy, Howard University, Washington, DC, 3DPQR, CDER, FDA, Silver Spring, MD, 4DPQR, CDER, FDA, Siver Spring, MD

  287. F-13
    Micro Structure Development and Release Behavior in Controlled Drug Delivery Systems
    D. M. Saylor1 , M. K. McDermott1 , B. J. Dair1 , C. S. Kim1 , J. Toy2 , D. V. Patwardhan1 , J. A. Warren3 , 1OSEL,CDRH,FDA, Rockville, MD, 2ODE,CDRH,FDA, Rockville, MD, 3NIST, Gaithersburg, MD

  288. F-14
    Effect of Materials Selection in Controlled Drug Delivery Systems: (Bio)Degradable v. Non-Degradable Polymers
    D. M. Saylor1 , M. K. McDermott1 , B. J. Dair2 , J. Toy1 , D. V. Patwardhan1 , J. A. Warren3 , 1OSEL,CDRH,FDA, Rockville, MD, 2ODE,CDRH,FDA, Rockville, MD, 3NIST, Gaithersburg, MD

  289. F-15
    In Vitro Characterization of Fentanyl Transdermal Systems
    S. Prodduturi, A. M. Wokovich, B. J. Westenberger, L. F. Buhse, W. H. Doub, DPA, OTR, CDER, FDA, St. Louis, MO

  290. F-16
    Vacuolar Growth in Foldable IOLs: Toward a Preclinical Test
    S. Salas-Vega, D. C. Richardson, CDRH, FDA, Rockville, MD

  291. F-17
    Modeling Time-dependent and Cycle-dependent Capacity Fade in Rechargeable Lithium-ion Batteries in an Implantable Neurostimulator
    E. Scott, A. Crespi, C. Schmidt, Medtronic, Inc.

  292. F-18
    Formulation, Evaluation and Progress of Emulsion Formation of an Alternative Self-Nanoemulsified Drug Delivery System of Cyclosporine A
    A. S. Zidan1 , M. A. Habib2 , O. A. Khan3 , R. B. Shah4 , 1Visiting Student, DPQR, CDER, FDA, SIlver spring, MD. School of Pharmacy, Howard University, Washington DC., 2School of Pharmacy, Howard University, Washington DC, 3Summer intern, OPS, CDER, FDA, Silver spring, MD, 4DPQR, CDER, FDA, Silver spring, MD

  293. F-19
    Physical Properties of Abdominal Adhesion Barriers
    K. Vorvolakos, H. D. Luu, D. V. Patwardhan, I. S. Isayeva, S. K. Pollack, FDA-CDRH-OSEL-DCMS

  294. F-20
    The Effects of Position with Respect to the Heart on Pulse Oximetry Measurements
    S. Weininger1 , A. B. Shang2 , 1CDRH, 2Duke Univerisity

  295. F-PO-21
    Disulfide bonds do not influence proteolytic digestion patterns of alpha-1-PI polymers*
    E. Marszal, R. A. Boykins, A. Shrake, CBER, FDA, Bethesda, MD 20892

  296. F-22
    Synthesis and Characterization of an Iron-Crosslinked Hyaluronic Acid-Based (FeHa) Adhesion Barrier
    I. Isayeva1, H.D. Luu1, J. DeFoe2, D. Patwardhan1, A. Chen3, K. Vorvolakos1, and S.S. Das1, 1Division of Chemistry and Materials Science, Office of Science and Engineering Laboratories, CDRH/FDA, Rockville, MD 20852, 2Department of Chemistry, Marquette University, Milwaukee, WI 53233, 3Thomas S. Wootton High School Rockville, MD 20850

    297. CATEGORY G: BIOSTATISTICS AND DESIGN AND EVALUATION OF CLINICAL TRIALS
    Menu

  297. G-01
    Coding of Indicator Variables When There Is an Interaction Term. A Cautionary Tale.
    P. E. Bonangelino, E. Russek-Cohen, CDRH, FDA, Rockville, MD

  298. G-02
    Emerging Trends in Clinical Trial Data Integration and Management
    P. Chakraborty, S. Nagaraja, Cognizant Technology Solution

  299. G-03
    Crossover Designs for Drug Abuse potential Clinical Trials
    L. Chen, Y. Tsong, CDER, FDA, White Oak, MD

  300. G-04
    Comparing Diagnostic Sensitivities With a Doctor in the Loop
    B. D. Gallas1 , G. A. Pennello2 , 1OSEL/CDRH/FDA Rockville MD, 2OSB/CDRH/FDA Rockville MD

  301. G-05
    Conservative or anti-conservative?: ITT and PP approach in RCT
    Y. Gao, L. Thompson, FDA

  302. G-06
    Estimating the Relative Efficiency of Odds Ratio Estimates by the Bootstrap Technique
    P. T. Liu, Q. F. Graves, CFSAN

  303. G-07
    Toward an integrated analysis of risk and benefit in clinical research
    S. Hirschfeld, CBER FDA, Rockville, MD

  304. G-08
    Calculation of Z Values for a Phase 1 Alanine Aminotransferease Data Set
    G. F. Kapke, J. Leroux, Covance Central Laboratory Services, Indianapolis, IN

  305. G-09
    Gender-specific statistical models of pathological coronary arteries for generating simulated angiograms
    I. S. Kyprianou1 , L. Thompson2 , D. Banh1 , W. Pritchard3 , J. Karanian4 , L. Rosen5 , K. J. Myers1 , 1NIBIB/CDRH Joint Laboratory for the Assessment of Medical Imaging Systems, US Food and Drug Administration, Rockville, MD, USA, 2OSB/DBS/CODB, Rockville, MD, USA, 3OSEL/DSFM, Rockville, MD, USA, 4OSEL/DB, Rockville, MD, USA, 5NIH/CSR, Bethesda MD

  306. G-10
    Evaluating Multiple Endpoints Collectively in Clinical Trials
    Q.H. Li, CDER, FDA, Silver Spring, MD

  307. G-11
    Statistical Considerations in the Evaluation of RBC Products
    T. Ng1 , P. He2 , J. Kim1 , P. Hshieh1 , 1CBER, FDA, Rockville, MD, 2CBER, FDA, Bethesda, MD

  308. G-12
    Can "Weight Only" Method be Used to Determine the Post-Filtration Red Blood Cell In Vitro Recovery for Quality Control Validation?
    T. Ng1 , B. J. Poindexter2 , J. G. Vostal2 , P. He2 , 1CBER, FDA, Rockville, MD, 2CBER, FDA, Bethesda, MD

  309. G-13
    Frequentist and Bayesian are Complementing Each Other
    T. Ng, CBER, FDA, Rockville, MD

  310. G-14
    Simultaneous Testing of Noninferiority and Superiority increases the False Discovery Rate
    T. Ng, CBER, FDA, Rockville, MD

  311. G-15
    Comparing Image Detection Algorithms using Resampling
    F. W. Samuelson, N. Petrick, CDRH, FDA, Rockville, MD

  312. G-16
    Interchangeability of the two measurement systems of the anthrax vaccine potency: Toxin Neutralization Assay and ELISA.
    L. A. Sirota1 , B. G. Zaslavsky1 , P. M. Parreiras2 , L. D. Wagner1 , S. L. Menzies1 , J. L. Arciniega1 , 1CBER, FDA, Rockville MD 20852, 2NIQCH, Rio de Janeiro, RJ 21.040-900 - Brazil

  313. G-17
    ON ESTIMATION OF THE PROPORTION OF TREATMENT BENEFIT WITH A CONTINUOUS RESPONSE WITHOUT DICHOTOMIZATION
    Y. Tsong, CDER, FDA, Silver Spring, MD

  314. G-18
    DEPENDENCY OF NON-INFERIORITY TRIALS
    J. Zhang, Y. Tsong, CDER, FDA, Silver Spring, MD

  315. G-19
    SEQUENTIAL ADAPTIVE SAMPLE SIZE RE-ESTIMATION FOR PAIR-MATCHED BINARY DATA
    Y. Tsong, CDER, FDA, Silver Spring, MD

  316. G-20
    AN ALTERNATIVE APPROACH TO ASSESS EXCHANGEABLILITY OF A NEW TEST TREATMENT
    Y. Tsong, M. Shen, CDER, FDA, Silver Spring, MD

  317. G-21
    Non-inferiority testing with a variable margin
    Z. Zhang, CDRH, FDA, Rockville, MD

  318. G-22
    Statistical Considerations for Lot Release Sampling Procedures
    B.A. Zhen, CBER, FDA, Rockville, MD

  319. G-PO-23
    Issues of a Thorough QT/QTc study
    J. Zhang, CDER, FDA, White Oak

    CATEGORY H: PROCESS ANALYTICAL TECHNOLOGY (PAT) AND PHARMACEUTICAL TECHNOLOGY
    Menu

  320. H-01
    PAT for Monitoring the Blend Homogeneity of an Active in a Tumble Mixer: Feasibility Studies and Real Time Experience.
    M. Ashraf1 , R. Chatpalli1 , M. A. Mahmud1 , A. Nagi1 , L. Sivieri2 , 1Wyeth Research, Pearl River, NY, 2Wyeth Pharma, Collegeville, PA

  321. H-02
    Control of Particle Size Distribution using PAT
    S. Bhansali, J. Liang, S. S. Deshmukh, Wyeth Research

  322. H-03
    ReactIR as a PAT Tool for the Online Reaction Monitoring of a Boronate Intermediate in the Manufacture of Temsirolimus
    W. Chew1 , W. McMahon2 , C. C. Shaw1 , 1Preclinical Development, Wyeth Research, Montreal, Canada, 2Preclinical Development, Wyeth Research, Pearl River, NY

  323. H-04
    PAT tools for evaluation of drug substance crystallization
    S. S. Deshmukh1 , M. Mirmehrabi2 , 1Wyeth Research, 2Wyeth Canada

  324. H-05
    The Impact of Segregation on Spectroscopic Process Measurements
    B. J. Ennis1 , C. D. Ellison2 , M. L. Hamad2 , A. S. Carlin2 , E. H. Jefferson2 , R. C. Lyon2 , 1E&G Associates, Nashville, TN 37215, 2DPQR, CDER, FDA, Silver Spring, MD, 20993

  325. H-06
    Characterizing the Impact of Wall and Powder Friction on Tablet Uniformity as Measured by Shear Cell and Chemical Imaging
    B. J. Ennis1 , C. D. Ellison2 , M. L. Hamad2 , E. H. Jefferson2 , R. C. Lyon2 , 1E&G Associates, Nashville, TN 37215, 2DPQR, CDER, FDA, Silver Spring, MD

  326. H-07
    Process Analytical Technology and Rapid Microbiological Methods using the Chemunex Scan RDI
    M. Farris1 , A. McDaniel2 , 1Wyeth Research, 2Wyeth Biopharma

  327. H-08
    Monitoring of manufacturing changes and formulation excipients on solid oral dosage forms of furosemide using chemometrics and laser-induced breakdown spectroscopy (LIBS)
    F. R. Doucet1 , L. St-Onge1 , M. Tourigny2 , M. Sabsabi1 , R. C. Lyon3 , P. J. Faustino3 , 1National Research Council of Canada, Boucherville, Canada, 2Pharma Laser, Boucherville, Canada, 3Division of Product Quality Research, Office of Pharmaceutical Science, CDER, FDA

  328. H-09
    Thermal Effusivity Application as a PAT Tool to Monitor and Control Roller Compaction Processes
    M. K. Ghorab, R. Chatpalli, S. Hasan, A. Nagi, Solids-Pharmaceutical R&D, Chemical and Pharmaceutical Development, Wyeth Research, Pearl River, NY 10965

  329. H-10
    Residual Solvent Drying Endpoint Detection Using Process Mass Spectrometry
    W. Chew, G. Glasier, E. Fournier, L. Karim, Wyeth Research, Montreal, Canada

  330. H-11
    Use of Raman imaging for determination of the particle size distribution (PSD) of active pharmaceutical ingredients (APIs) in metered-dose inhalers (MDI)
    C. Guo, W. H. Doub, DPA, CDER, FDA, St. Louis, MO

  331. Sigma Xi Winning Poster Ribbon iconH-12
    Imaging-Based Algorithms for Determining the Uniformity of Drug Products and Blends
    M. L. Hamad, C. D. Ellison, A. S. Carlin, E. H. Jefferson, M. A. Khan, R. C. Lyon, DPQR, CDER, FDA, Silver Spring, MD

  332. H-13
    Near-infrared Transflectance Spectroscopy for the Quantitative Assessment of Gabapentin Concentration in Aqueous Solution
    M. Durette1 , S. Kislalioglu2 , M. L. Hamad3 , A. NguyenPho3 , M. A. Khan3 , 1DPQR, CDER, FDA, Silver Spring, MD & Department of Pharmacy, University of Rhode Island, Kingston