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Design and analysis of bioavailability and bioequivalence studies / Shein-Chung Chow, Jen-pei Liu

By: Chow, Shein-Chung, 1955-
Contributor(s): Liu, Jen-pei, 1952-
Material type: TextTextSeries: Chapman & Hall/CRC biostatistics series: 27Publisher: Boca Raton : CRC Press, c2009Edition: 3rd edDescription: xxii, 733 p. : ill. ; 25 cmISBN: 9781584886686 (hardback : alk. paper); 1584886684 (hardback : alk. paper)Subject(s): Bioavailability -- Research -- Statistical methods | Drugs -- Therapeutic equivalency -- Research -- Statistical methods | Biological Availability | Statistics as Topic -- methods | Therapeutic EquivalencyDDC classification: 615.7 LOC classification: RM301.6 | .C46 2009RM301.6 | .C46 2009
Contents:
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
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Books Books Centeral Library
Second Floor - Pharmacy
615.7 C.H.D 2009 (Browse shelf) Available 12742-1

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

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