Moment-based criteria for determining bioequivalence

Abstract

SUMMARY In comparative bioavailability trials, the focus in the determination of bioequivalence has been to show that the average bioavailability on a test formulation is similar to the average bioavailability on a reference formulation. It has been argued that this is not adequate to insure interchangeability of formulations. We introduce a moment-based criterion which ensures interchangeability for at least a certain proportion of the population. An algorithm is given for determining the constant in the criterion. An example is used to illustrate how the criterion may be applied.