Design and analysis of bioavailability and bioequivalence studies /
Chow, Shein-Chung,
Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu. - 3rd ed. - Boca Raton : CRC Press, c2009. - xxii, 733 p. : ill. - Chapman & Hall/CRC biostatistics series .
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.
9781584886686 (hardcover : alk. paper)
Biological Availability
Statistics as Topic
Therapeutic Equivalency
QV 38 / .C46 2009
Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu. - 3rd ed. - Boca Raton : CRC Press, c2009. - xxii, 733 p. : ill. - Chapman & Hall/CRC biostatistics series .
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.
9781584886686 (hardcover : alk. paper)
Biological Availability
Statistics as Topic
Therapeutic Equivalency
QV 38 / .C46 2009