Toxicokinetics and Risk Assessment: 1st Edition (e-Book) book cover

Toxicokinetics and Risk Assessment

1st Edition

Edited by John C. Lipscomb, Edward V. Ohanian

CRC Press

361 pages

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Hardback: 9780849337222
pub: 2006-10-10
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pub: 2016-04-19
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Toxicokinetics in 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. This text clearly demonstrates the application of physiologically-based pharmacokinetic (PBPK) modeling in human healt

Table of Contents

Overview of the Approach to Noncancer Risk Assessment o Guidance for the Development of Chemical Specific Adjustment Factors: Integration with Mode of Action Frameworks o Derivation and Modeling of Mechanistic Data for Use in Risk Assessment o 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 o Use of Classical Pharmacokinetic Evaluations in Drug Development and Safety Assessment o Considerations for Applying Physiologically Based Pharmacokinetic Models in Risk Assessment o Considerations of Design and Data when Developing Physiologically Based Pharmacokinetic Models o In Silico Predictions of Partition Coefficients for Physiologically Based Pharmacokinetic Models o In Vitro to In Vivo Extrapolation of Metabolic Rate Constants for Physiologically Based Pharmacokinetic Models o Use of Physiologically Based Pharmacokinetic Modeling to Evaluate Implications of Human Variability o Developmental Aspects of Children's Pharmacokinetics o Sensitive Populations and Risk Assessment o Statistical Issues in Physiologically Based Pharmacokinetic Modeling o Drug Development and the Use of Pharmacokinetics/Toxicokinetics in Selecting the First Dose of Systemically Administered Drugs in Humans-A Nonclinical Perspective o Pharmacokinetic/PBPK Models in IRIS Assessments

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
MEDICAL / Toxicology