Pharmacokinetics in Drug Development: Clinical Study Design and Analysis (Volume 1) - Peter L Bonate - Books - AAPS Press - 9780971176744 - December 5, 2005
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Peter L Bonate
Pharmacokinetics in Drug Development: Clinical Study Design and Analysis (Volume 1) 2004 edition

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These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Marc Notes: Includes bibliographical references and index. Table of Contents: First-Time-in-Man Studies.- Drug-Drug Interactions.- Food Effect Studies.- Bioavailability and Bioequivalence Studies.- Mass Balance Studies.- Design, Conduct, and Analysis of Studies in Patients with Hepatic Impairment.- Design, Conduct, and Analysis of Studies in Patients with Renal Impairment.- Special Populations.- Non-compartmental Analysis.- Analysis of Urine Excretion Data.- Compartmental Models.- The Role of Metabolite Pharmacokinetics and Pharmacodynamics in Drug Development.- Average, Population, and Individual Bioequivalence.- Assessment of Dose Proportionality.- Analysis of Absorption Kinetic Data.- Interspecies Pharmacokinetic Scaling: Principles, Applications, and Limitations.- In Vitro Drug Metabolism Information in the Prediction of Human Pharmacokinetics.- Practical Deconvolution.- Population Pharmacokinetics: Applications in Industry.- Clinical Trial Simulation.- The Strategic Role and Application of Pharmacokinetic/Pharmacodynamic Modeling in Drug Development.- The Analysis of Clincal Safety Data in Phase I-II Pharmacokinetic Studies.

Media Books     Hardcover Book   (Book with hard spine and cover)
Released December 5, 2005
ISBN13 9780971176744
Publishers AAPS Press
Pages 628
Dimensions 178 × 254 × 34 mm   ·   1.32 kg
Language English  
Editor Bonate, Peter L.
Editor Howard, Danny R.

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