FOR PARAMETRIC AND NONPARAMETRIC ASSESSMENT OF BIOEQUIVALENCE

A simple three-step approach for the assessment of bioequivalence is proposed. According to the decision rule of this approach, average bioequivalence is assessed first (Step 1). lf approved, then population bioequivalence will be assessed next (Step 2). Again, if approved, then individual bioequivalence can be assessed as thefinal stage (Step 3). For the evaluation of these bioequivalence criteria, parametric and nonparametric testing procedures are suggested on the original and logarithmic scale of measurement. A clear advantage of these testing procedures is that they can be set up using elementary test statistics and, therefore, they are readily accessible to the practitioners. An example is also presented to illustrate the method