On statistical power for average bioequivalence testing under replicated crossover designs.

Abstract

In its recent guidance on bioequivalence, the U.S. Food and Drug Administration (FDA) recommends a two-sequence, four-period (2 x 4) replicated crossover design be used for assessment of population and individual bioequivalence [FDA. Guidance for Industry on Statistical Approaches to Establishing Bioequivalence; Center for Drug Evaluation and Research, Food… (More)

4 Figures and Tables

Topics

  • Presentations referencing similar topics