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

By: Contributor(s): Material type: TextTextSeries: 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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Item type Current library Call number Status Date due Barcode
Books 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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