|aDesign and analysis of bioavailability and bioequivalence studies /|cShein-Chun Chow, Jen-pei Liu.
|aBoca Raton :|bCRC Press,|cc2009.
|axxii, 733 p. :|bill. ;|c25 cm.
|aChapman & Hall/CRC biostatistics series ;|v27
|a"A Chapman & Hall book."
|aIncludes bibliographical references (p. 647-667) and index.
|aDesign 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.