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Tolerance intervals for assessing individual bioequivalence
E B Brown1, H K Iyer, C M Wang
1Department of Statistics, Colorado State University, Fort Collins 80523, USA.
Statistics in Medicine
|April 15, 1997
Abstract:
Evaluation of equivalence of two formulations of a drug typically entails the comparison of average bioavailabilities. Recently, however, authors have become aware that this may be insufficient to assess individual bioequivalence, that is, interchangeability of formulations on an individual basis. This paper outlines a tolerance interval procedure to assess individual bioequivalence based on a model that includes a subject by formulation interaction. We give methods for several higher-order cross-over designs along with examples.