Bioequivalence Studies in Drug Development: Methods and Applications
John Wiley & Sons, Mar 13, 2007 - Medical - 328 pages
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.
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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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