Library of American University of Madaba
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Chow, Shein-Chung, 1955-
Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu. - 3rd ed. - Boca Raton, FL : CRC Press, 2009. - xxii, 733 p. : ill. ; 25 cm. - 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 (hardback : alk. paper) 1584886684 (hardback : alk. paper)
Bioavailability--Research--Statistical methods.
Drugs--Therapeutic equivalency--Research--Statistical methods.
Biological Availability.
Statistics as Topic--methods.
Therapeutic Equivalency.
RM301.6 / .C46 2009
615.7 / C46
Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu. - 3rd ed. - Boca Raton, FL : CRC Press, 2009. - xxii, 733 p. : ill. ; 25 cm. - 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 (hardback : alk. paper) 1584886684 (hardback : alk. paper)
Bioavailability--Research--Statistical methods.
Drugs--Therapeutic equivalency--Research--Statistical methods.
Biological Availability.
Statistics as Topic--methods.
Therapeutic Equivalency.
RM301.6 / .C46 2009
615.7 / C46