Blume H H, Midha K K
College of Pharmacy, University of Saskatchewan, Saskatoon, Canada.
J Pharm Sci. 1993 Nov;82(11):1186-9. doi: 10.1002/jps.2600821125.
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.
本报告总结了1992年生物国际会议上关于高变异药物生物等效性(第一和第二场会议)、代谢物在生物等效性评估中的重要性(第二场会议)以及生物等效性研究中食物效应测定(第四场会议)等突出主题的讨论和陈述。1992年生物国际会议的目标是探讨此前会议(如1989年在多伦多召开的生物国际会议以及1991年在巴塞罗那召开的药物信息协会(DIA)生物利用度/生物等效性会议)提出的一些关键问题。邀请了对这些主题感兴趣并有相关经验的监管机构、控制实验室、学术界和行业的科学家,就该领域的科学技术现状进行公开讨论并发表意见。