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9781420019308

Toxicokinetics and Risk Assessment

by
  • ISBN13:

    9781420019308

  • ISBN10:

    1420019309

  • Format: Nonspecific Binding
  • Copyright: 2016-04-19
  • Publisher: Taylor & Francis

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Table of Contents

Overview of the Approach to Noncancer Risk Assessment
Guidance for the Development of Chemical Specific Adjustment Factors: Integration with Mode of Action Frameworks
Derivation and Modeling of Mechanistic Data for Use in Risk Assessment
Empirically Observed Distributions of Pharmacokinetic and Pharmacodynamic Variability in Humans-Implications for the Derivation of Single Point Component Uncertainty Factors Providing Equivalent Protection as Existing RFDs
Use of Classical Pharmacokinetic Evaluations in Drug Development and Safety Assessment
Considerations for Applying Physiologically Based Pharmacokinetic Models in Risk Assessment
Considerations of Design and Data when Developing Physiologically Based Pharmacokinetic Models
In Silico Predictions of Partition Coefficients for Physiologically Based Pharmacokinetic Models
In Vitro to In Vivo Extrapolation of Metabolic Rate Constants for Physiologically Based Pharmacokinetic Models
Use of Physiologically Based Pharmacokinetic Modeling to Evaluate Implications of Human Variability
Developmental Aspects of Children's Pharmacokinetics
Sensitive Populations and Risk Assessment
Statistical Issues in Physiologically Based Pharmacokinetic Modeling
Drug Development and the Use of Pharmacokinetics/Toxicokinetics in Selecting the First Dose of Systemically Administered Drugs in Humans-A Nonclinical Perspective
Pharmacokinetic/PBPK Models in IRIS Assessments
Table of Contents provided by Publisher. All Rights Reserved.

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