Sample Size Calculation for the Therapeutic Equivalence Problem

Abstract

A method is proposed for the sample size calculation in the case of therapeutic equivalence of two pharmaceuticals, when the decision is based on post-treatment differences and the post-treatment values are dependent on the pretreatment ones. When the correlation coefficient is large (over 0.7), it is shown that sample size calculation (and the corresponding hypothesis test) based on the sample statistic formed by the mean difference of the post–pre differences of each group has smaller variance and hence leads to smaller sample sizes.

Keywords:

• Bioequivalence
• Hypothesis testing
• Sample size

Mathematics Subject Classification:

• 62F03
• 62P10
• 92C50