Bioequivalence

Article originally published in Encyclopedia of Biostatistics, 2nd Edition (2005, John Wiley & Sons, Ltd).

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Laszlo Endrenyi

Laszlo Endrenyi

University of Toronto, Toronto, Ontario, Canada

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First published: 15 September 2008

Abstract

Bioequivalence is defined as the comparable bioavailability of alternative drug formulations. Kinetic measures of bioavailability are reviewed, leading to a discussion of the statistical assessment of bioequivalence. Parametric and nonparametric methods of testing are described. Current research areas, including the estimation of individual bioequivalence and alternative measures for the evaluation of bioequivalence, are reviewed.

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