This report summarizes the discussions and statements of the Bio-International '92 conference concerning the topics highlighted at the sessions on bioequivalence of highly variable drugs (sessions I and II), importance of metabolites in assessment of bioequivalence (session II), and determination of food effects in bioequivalence studies (session IV). The objective of BIO-International '92 was to take up some key issues raised in former conferences such as BIO-international '89 in Toronto and the Drug Information Association (DIA) meeting on bioavailability/bioequivalence in Barcelona 1991. Scientists from regulatory bodies, control laboratories, academia, and industry who were interested in and experienced with the topics were invited to contribute to the open discussions regarding the state of science and technology in this field.