Comparison of different methods for decision-making in bioequivalence assessment.

Metzler (1974) has discussed methodological and statistical problems arising in bioavailability experiments. We shall focus attention on the following situation: two formulations of a given drug a standard, S, and a new formulation, N, are to be compared in a crossover trial with n subjects. On the basis of one clinical parameter it has to be decided whether the formulations should be regarded as bioequivalent. If ZN > 0 and Zs > 0 represent the true values of the chosen clinical parameter when N and S, respectively, are applied, bioequivalence is defined by the condition r1S0bioequivalence assessment problem should instead be viewed in the following terms: