On Sample Size Determination for Bioequivalence Studies Based on Confidence Intervals

Abstract

In the guideline for bioequivalence studies published in 1997, the decision for bio equivalence is basically based on the confidence intervals for AUC and C_max.This decision is equivalent to rejecting two one-sided hypotheses by the two one-sided tests procedure. For the sample size determination, we must consider the statistical power, i. e., the probability of correctly accepting bioequivalence. This paper describes the sample size determination for bioequivalence studies giving consideration to the statisti cal power.