TY  - BOOK
AU  - Chow, Shein-Chung,
AU  - Liu, Jen-pei,
TI  - Design and analysis of bioavailability and bioequivalence studies
T2  - Chapman & Hall/CRC biostatistics series 
SN  - 9781584886686 (hardcover : alk. paper)
PY  - 2009///
CY  - Boca Raton
PB  - CRC Press
KW  - Biological Availability
KW  - Statistics as Topic
KW  - Therapeutic Equivalency
N1  - A Chapman & Hall book; 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
ER  -