Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu.

Author/creator Chow, Shein-Chung, 1955-
Other author Liu, Jen-pei, 1952-
Format Electronic
Edition3rd ed.
Publication InfoBoca Raton : CRC Press,
Descriptionxxii, 733 p. : ill. ; 25 cm.
Supplemental ContentFull text available from eBooks on EBSCOhost
Subjects

SeriesChapman & 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.
General note"A Chapman & Hall book."
Bibliography noteIncludes bibliographical references (p. 647-667) and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2008025461
ISBN9781584886686 (hardback : alk. paper)
ISBN1584886684 (hardback : alk. paper)

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