Design and analysis of bioavailability and bioequivalence studies /
Shein-Chung Chow, Jen-pei Liu
- 3rd ed
- Boca Raton : CRC Press, c2009
- xxii, 733 p. : ill. ; 25 cm
- Chapman & Hall/CRC biostatistics series ; 27 .
- Chapman & Hall/CRC biostatistics series ; 27 .
Includes bibliographical references (p. 647-667) and index
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