Bioequivalence Studies in Drug Development: Methods and Applications

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John Wiley & Sons, Mar 13, 2007 - Medical - 328 pages
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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.

  • 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.
  • Reviews the regulatory guidelines for such studies, and the existing global discrepancies.
  • Discusses the designs and analyses of drug-drug and food-drug interaction studies.

Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.


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1 Introduction
2 Metrics to characterize concentrationtime profiles in single and multipledose bioequivalence studies
3 Basic statistical considerations
4 Assessment of average bioequivalence in the RTTR design
5 Power and sample size determination for testing average bioequivalence in the RTTR design
6 Presentation of bioequivalence studies
7 Designs with more than two formulations
8 Analysis of pharmacokinetic interactions
9 Population and individual bioequivalence
10 Equivalence assessment for clinical endpoints

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About the author (2007)

Dieter Hauschke, ALTANA Pharma, Konstanz, Germany. Well-respected statistician working in the pharmaceutical industry, specializing in bioequivalence studies, with over 60 publications in leading journals.

Volker Steinijans, ALTANA Pharma, Konstanz, Germany. Head of the Department of Biometry and Clinical Data Management at ALTANA.

Iris Pigeot, Institute for Statistics, University of Bremen, Germany. Has over 50 published papers, and also written a number of books in German.

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