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Title Design and analysis of bioavailability and bioequivalence studies / Shein-Chung Chow, Jen-pei Liu.
Imprint Boca Raton : CRC Press, ©2009.


 Internet  Electronic Book    AVAILABLE
Edition 3rd ed.
Description 1 online resource (xxii, 733 pages) : illustrations.
Series Chapman & Hall/CRC biostatistics series ; 27
Chapman & Hall/CRC biostatistics series ; 27.
Bibliog. Includes bibliographical references (pages 647-667) and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Bioavailability -- Research -- Statistical methods.
Drugs -- Therapeutic equivalency -- Research -- Statistical methods.
Biological Availability.
Statistics as Topic -- methods.
Therapeutic Equivalency.
Genre Electronic book.
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.
Other Author Liu, Jen-pei, 1952-
Other Title Print version: Chow, Shein-Chung, 1955- Design and analysis of bioavailability and bioequivalence studies. 3rd ed. Boca Raton : CRC Press, ©2009 9781584886686 1584886684