ABSTRACT
The concept of bioequivalence is well established as a surrogate method for determining therapeutic equivalency of drug products among agencies regulating medicines. Therefore, it is the purpose of the bioequivalence study to demonstrate that the profiles produced by the formulations under study do not differ significantly. The only purpose for a bioequivalence study is to obtain evidence that the test formulation and the reference formulation are indeed “close” enough. The most common statistical distribution parameter on which to base bioequivalence is a measure of central tendency of the test to reference product bioavailability metric. An example to illustrate how this proportional effect impacts on bioequivalence studies may be helpful. The goal of any bioequivalence study is to compare, using estimates from the data, the closeness of the distribution parameters of the experimental and reference formulations. There are two general types of designs which could be used in a bioequivalence study. These are the parallel and the crossover design.
