On Sample Size Calculation in Bioequivalence Trials

Sample size calculations play an important role in bioequivalence trials. In almost all clinical trials sample size is determined by considering power under the alternative hypothesis. The alternative hypothesis is the hypothesis that we wish to prove with experiments. Hence, in bioequivalence trials the alternative hypothesis is that two formulations are bioequivalent, while the null hypothesis is that the two formulations are not bioequivalent. (omitted)