Verifying Hypotheses of Drug Bioequivalence

Abstract

The problem of testing pharmaceuticals on their bioequivalence is considered. Investigations of drug bioequivalence are the basis for reproducing drugs that confirm their efficiency and safety. The main way of verifying drug bioequivalence is to conduct two one-sided Schuirmann tests. Two one-sided tests have been used for many years and proven their validity for proving equivalent bioavailability, but in some situations (missing data, the necessity of considering not only the aggregate metrics but also the shape of the concentration–time curve) there is a need to establish more accurately the differences between the concentration–time curves. The authors present a new criterion that is more sensitive to the differences between characteristics that affect drug bioavailability and reduce the risk for patients. In should be noted that the new criterion generalizes the Schuirmann criterion and preserves its useful properties.