U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Plant & Dairy Foods & Beverages
February 24-25, 2003


Food Advisory Committee Meeting:
Acrylamide

Animal Studies and Human Health Consequences

February 24-25, 2003

[Transcript of Dr. Schwartz's remarks]

Begin Presentation

Author: Dr. Sorell Schwartz

Table of Contents
  1. Animal Studies and Human Health Consequences
  2. Pharmacokinetics v. Pharmacodynamics
  3. Pharmacokinetic Dose Extrapolation
  4. Interspecies Scaling(Essentially) Isometric Proportion to body weight is constant across species
  5. Interspecies Scaling Allometric Proportion to body weight varies exponentially across species
  6. Pharmacokinetic Factors Affecting Efficacy of Interspecies Extrapolations
  7. Volume of Distribution
  8. Clearance (Cl) Blood flow (Q) Extraction Ratio (ER)
  9. Absorption & Bioavailability (F)
  10. Absorption & Bioavailability Interspecies Scalability
  1. Allometric Reliability Likely to be More Reliable
  2. Allometric Reliability Likely to be Less Reliable
  3. Allometric Approaches to Clearance
  4. Allometric Approaches to Clearance (Empirical)
  5. Physiologically Based PK-PD Model
  6. PBPK Modeling of Metabolite
  7. Application of PBPK Modeling to Low Dose/Interspecies Extrapolation
  8. Application of PBPK modeling to Low Dose/Interspecies Extrapolation
  9. Applications of PBPK Modeling in Risk Assessment


Presentations at Acrylamide Food Advisory Committee Meeting

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Acrylamide in Foods
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