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We investigate a confirmatory two stage adaptive procedure for assessingaverage bioequivalence and provide some insights to its theoretical properties.Effectively, we perform Two One-Sided Tests (TOST) to reach overall decisionabout each of the two traditional null-hypotheses involved in declaring averagebioequivalence. The tests are performed as combination tests separately foreach hypothesis based on the corresponding pair of stagewise p-values. Featuresof the procedure include a built in futility, sample size reassessment, and theability to simultaneously assess average bioequivalence with respect tomultiple endpoints while controlling the familywise error rate. To facilitateinference at the end of a trial we also derive overall confidence limits thatmatch the decision reached on each one sided hypothesis and provide theoryensuring their appropriateness. The performance is assessed by simulation inthe context of planning a study to compare two different administrations of abiologic treatment of atopic dermatitis.

Properties of a confirmatory two-stage adaptive procedure for assessing average bioequivalence