Toxicokinetics and Risk Assessment discusses the noncancer risk assessment process and its reliance on uncertainty factors in order to facilitate the continued study and refinement of the scientific basis for health risk assessment.

Features:

• Presents a historical perspective on the basis for human health risk assessment and its uncertainty factors
• Provides guidance on the inclusion of toxicokinetic data in risk assessment
• Includes a section devoted to Monte Carlo sampling techniques and statistical considerations for data demonstrating or predicting population variability, including variability based on genetic polymorphisms
• Demonstrates the advantages of translating external concentrations to internal doses for risk assessment purposes
• Addresses the concerns of multiple organizations and divergent staff levels

Contents

1. Overview of the Approach to Noncancer Risk Assessment
2. Guidance for the Development of Chemical Specific Adjustment Factors: Integration with Mode of Action Frameworks
3. Derivation and Modeling of Mechanistic Data for Use in Risk Assessment
4. Empirically Observed Distributions of Pharmacokinetic and Pharmacodynamic Variability in Humans-Implications for the Derivation of Single Point Component
5. Uncertainty Factors Providing Equivalent Protection as Existing RFDs
6. Use of Classical Pharmacokinetic Evaluations in Drug Development and Safety Assessment
7. Considerations for Applying Physiologically Based Pharmacokinetic Models in Risk Assessment
8. Considerations of Design and Data when Developing Physiologically Based Pharmacokinetic Models
9. In Silico Predictions of Partition Coefficients for Physiologically Based Pharmacokinetic Models
10. In Vitro to In Vivo Extrapolation of Metabolic Rate Constants for Physiologically Based Pharmacokinetic Models
11. Use of Physiologically Based Pharmacokinetic Modeling to Evaluate Implications of Human Variability
12. Developmental Aspects of Children's Pharmacokinetics
13. Sensitive Populations and Risk Assessment
14. Statistical Issues in Physiologically Based Pharmacokinetic Modeling
15. Drug Development and the Use of Pharmacokinetics/Toxicokinetics in Selecting the First Dose of Systemically Administered Drugs in Humans-A Nonclinical
16. Perspective
17. Pharmacokinetic/PBPK Models in IRIS Assessments

Index

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