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OverviewToxicokinetics 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 health risk assessment, as well as methods for data generation, extrapolation, and inclusion of laboratory results for chemical metabolism and computer-based predictions of biochemical constants to address estimates of variability between experimental animals and humans. This guide also includes recent examples of the use of toxicokinetic information to successfully replace default values for uncertainty factors with data-derived factors in risk assessments developed by the US Environmental Protection Agency. Full Product DetailsAuthor: John C. Lipscomb , Edward V. OhanianPublisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 15.20cm , Height: 2.50cm , Length: 22.90cm Weight: 0.635kg ISBN: 9780849337222ISBN 10: 0849337224 Pages: 382 Publication Date: 10 October 2006 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print  This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsOverview 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 AssessmentsReviewsAuthor InformationLipscomb, John C.; Ohanian, Edward V. Tab Content 6Author Website:Countries AvailableAll regions |
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