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Abstract

A Review Of The Development Of Biostatistical Design And Analysis Techniques For Assessing In Vivo Bioequivalence : Part Two

Author(s): Scott Patterson

Bioequivalence studies are performed to demonstrate that two pharmaceutically equivalent products are equal in rate and extent of absorption in vivo. Following on from developments in the pharmaceutical industry and government mandates in the 1970's and 1980's and since the early 1990's, average bioequivalence has served as the international standard for demonstrating that two formulations of drug product will provide the same therapeutic benefit and safety profile when used in the marketplace. Population (PBE) and Individual (IBE) bioequivalence has been the subject of intense international debate since methods for their assessment were proposed in the late 1980's. Guidance has been proposed by the Food and Drug Administration of theUnited States Government for the implementation of these techniques in the pioneer and generic pharmaceutical industries. A previous article described the basis for bioequivalence and discussed the development of techniques for design and analysis in average bioequivalence assessment. This paper, the conclusion of this series, describes the implementation of average bioequivalence in the pharmaceutical industry, and discusses the development of population and individual bioequivalence.