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 (hardback : alk. paper)
AV  - RM301.6 .C46 2009
U1  - 615.7 
PY  - 2009///
CY  - Boca Raton
PB  - CRC Press
KW  - Bioavailability
KW  - Research
KW  - Statistical methods
KW  - Drugs
KW  - Therapeutic equivalency
KW  - Biological Availability
KW  - Statistics as Topic
KW  - methods
KW  - Therapeutic Equivalency
N1  - 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  -