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Cover image for Design and analysis of bioavailability and bioequivalence studies
Title:
Design and analysis of bioavailability and bioequivalence studies
Author:
Chow, Shein-Chung, 1955-
ISBN:
9781420011678
Edition:
3rd ed.
Publication Information:
Boca Raton : Chapman & Hall/CRC, 2009.
Physical Description:
760 p.
Series:
Chapman & Hall/CRC biostatistics series ; 27
Series Title:
Chapman & Hall/CRC biostatistics series ; 27
Contents:
Design of bioavailability studies -- Statistical inferences for effects from a standard 22 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intrasubject 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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