Some observations on current and possible future developments in bioequivalency testing

Present trends in the evolution of the design and interpretations of bioequ ivalency studies are reviewed. It is suggested that, although such tests ar e now being increasingly regarded as clinical mirrors rather than simply qu ality control tests for final product testing, there is still the possibili ty of simplifying such procedures. However, care must be exercised to ensur e that changes in bioequivalency tests are introduced only after careful pu blic discussions, which should involve both regulators and pharmaceutical s cientists from academia and industry. Further, it is important that bioequi valency standards shall be internally consistent and applied in a political ly neutral manner.