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

By: Contributor(s): Material type: TextSeries: Chapman & Hall/CRC biostatistics series ; 27Publication details: Boca Raton : CRC Press, c2009Edition: 3rd edDescription: xxii, 733 p. : ill. ; 25 cmISBN:
  • 9781584886686 (hardback : alk. paper)
  • 1584886684 (hardback : alk. paper)
Subject(s): DDC classification:
  • 615.7
LOC classification:
  • RM301.6 .C46 2009
  • RM301.6 .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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Cover image Item type Current library Home library Collection Shelving location Call number Materials specified Vol info URL Copy number Status Notes Date due Barcode Item holds Item hold queue priority Course reserves
Books Centeral Library Second Floor - Pharmacy 615.7 C.H.D 2009 (Browse shelf(Opens below)) 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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