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Design and analysis of bioavailability and bioequivalence studies /

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Bibliographic Details
Main Author: Chow, Shein-Chung, 1955-
Other Authors: Liu, Jen-pei, 1952-
Format: Book
Language:English
Published: Boca Raton : CRC Press, [2009]
Edition:Third edition.
Series:Chapman & Hall/CRC biostatistics series ; 27.
Subjects:
Bioavailability > Research > Statistical methods.
Drugs > Therapeutic equivalency > Research > Statistical methods.
Biological Availability.
Statistics as Topic > methods.
Therapeutic Equivalency.
Table of 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.