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Abstract

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

Author(s): Scoot D 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 the United States government for the implementation of these techniques in the pioneer and generic pharmaceutical industries. Implementation of these techniques may follow a data collection period to evaluate the operating characteristics, efficiency, and metrics involved in PBE and IBE assessment. The history of bioequivalence will be described, and various techniques and study designs for in vivo bioequivalence assessment will be provided. Part One of this series will develop the ideas behind bioequivalence and discuss development of average bioequivalence. Part Two of this series will describe the implementation of average bioequivalence in industry and the development of population and individual bioequivalence.