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Author Chow, Shein-Chung, 1955-

Title Design and analysis of bioavailability and bioequivalence studies / Shein-Chung Chow, Jen-pei Liu
Edition Third edition
Published Boca Raton : CRC Press, [2009]
Online access available from:
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Description 1 online resource (xxii, 733 pages) : illustrations
Series Chapman & Hall/CRC biostatistics series ; 27
Chapman & Hall/CRC biostatistics series ; 27
Contents Design of bioavailability studies -- Statistical inferences for effects from a standard 2x2 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intra-subject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges
Bibliography Includes bibliographical references (pages 647-667) and index
Notes Print version record
Subject Bioavailability -- Research -- Statistical methods.
Drugs -- Therapeutic equivalency -- Research -- Statistical methods.
Biological Availability.
Statistics as Topic -- methods.
Therapeutic Equivalency.
Form Electronic book
Author Liu, Jen-pei, 1952-
ISBN 1420011677 (electronic bk.)
9781420011678 (electronic bk.)