MOMENT-BASED CRITERIA FOR DETERMINING BIOEQUIVALENCE

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 ref erence formulation. It has been argued that this is not adequate to in sure interchangeability of formulations. We introduce a moment-based c riterion which ensures interchangeability for at least a certain propo rtion of the population. An algorithm is given for determining the con stant in the criterion. An example is used to illustrate how the crite rion may be applied.