Testing equivalence in clinical trials using a new principle for constructing statistical tests
A new approach for testing bioequivalence based on a noncommon principle for testing statistical hypotheses is proposed. The tests are called profile tests at level a. The principle they are based on, originally developed by Ruger(1978, 1980), overcomes some essential difficulties of the classical Neyman Pearson approach. In particular, its decision rule allows symmetric test results which are ordered in a hierarchical manner. This article introduces the test principle and deals with the question of how to derive profile tests for the problem of equivalence studies. The considered approach has a solid statistical foundation and the resulting test procedure fulfills a maximin optimality criterion.