Design and analysis of bioavailability and bioequivalence studies - Chow, Shein-Chung, 1955-; Liu, Jen-pei, 1952- (Boca Raton : CRC Press, 2009)
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
Includes bibliographical references (p. 647-667) and index
Keywords: Bioavailability -- Research -- Statistical methods; Drugs -- Therapeutic equivalency -- Research -- Statistical methods; Biological Availability; Statistics as Topic -- methods; Therapeutic Equivalency