Some observations on current and possible future developments in bioequivalency testing.

Abstract

Present trends in the evolution of the design and interpretations of bioequivalency studies are reviewed. It is suggested that, although such tests are now being increasingly regarded as clinical mirrors rather than simply quality control tests for final product testing, there is still the possibility of simplifying such procedures. However, care must be exercised to ensure that changes in bioequivalency tests are introduced only after careful public discussions, which should involve both regulators and pharmaceutical scientists from academia and industry. Further, it is important that bioequivalency standards shall be internally consistent and applied in a politically neutral manner.