Description

Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development.


Key Features:-

  • Includes all the necessary pharmacokinetic background information.
  • Presents parametric and nonparametric statistical techniques.
  • Describes adequate methods for power and sample size determination.
  • Includes appropriate presentation of results from bioequivalence studies.
  • Provides a practical overview of the design and analysis of bioequivalence studies.
  • Presents the recent developments in methodology, including population and individual bioequivalence.

More Details about Bioequivalence Studies in Drug Development Methods and Applications (HB)

General Information  
Author(s)Hauschke
PublisherJohn Wiley
ISBN9780470094754
Pages311
BindingHard Back
LanguageEnglish
Publish YearJanuary 2007