Bioequivalence studies in drug development : methods and applications /

Bioequivalence studies in drug development : methods and applications /

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Bibliographic Details
Main Author: Hauschke, Dieter
Corporate Author: Wiley InterScience (Online service)
Other Authors: Pigeot, Iris, Steinijans, Volker
Format: eBook
Language:English
Published: Chichester, England ; Hoboken, NJ : Wiley, [2007]
Series:Statistics in practice.
Subjects:
Drugs > Therapeutic equivalency.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies
  • Basic statistical considerations
  • Assessment of average bioequivalence in the RT/TR design
  • Power and sample size determination for testing average bioequivalence in the RT/TR design
  • Presentation of bioequivalence studies
  • Designs with more than two formulations
  • Analysis of pharmacokinetic interactions
  • Population and individual bioequivalence
  • Equivalence assessment for clinical endpoints.