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Design and analysis of bioavailability and bioequivalence studies /

by Chow, Shein-Chung,
Authors: Liu, Jen-pei,%1952-%joint author Series: Chapman & Hall/CRC biostatistics series Published by : CRC Press, (Boca Raton, FL :) Physical details: xxii, 733 p. : ill. ; 25 cm. ISBN: 1584886684 Subject(s): Bioavailability %Research %Statistical methods. | Drugs %Therapeutic equivalency %Research %Statistical methods. | Biological Availability. | Statistics as Topic %methods. | Therapeutic Equivalency. Year: 2009
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Item type Location Call Number Status Notes Date Due
Book Book AUM Main Library 615.7 C46 (Browse Shelf) Available JBC/2011/11367
Book Book AUM Main Library 615.7 C46 (Browse Shelf) Available JBC/2011/11367

"A Chapman & Hall book."

Includes bibliographical references (p. 647-667) and index.

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.

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