过去10年中,对生物等效性研究的设计、实施和评价已经引起了学术界、医药工业界、卫生部门的极大关注和重视。尽管许多地区性和全国性团体在制定指导原则和推荐原则上作出了艰苦的努力,但仍无一个统一的标准。为了避免生物等效性研究中的巨额费用和大量类似研究的不必要重复,有必要制定一个标准。最近(1991年)由药物信息协会(DIA)举办的一次“生物利用度/生物等效性:药代 In the past 10 years, the design, implementation and evaluation of bioequivalence research have drawn great attention and attention from academia, medical industry and health department. Although many regional and national groups have made painstaking efforts in setting guidelines and recommending principles, there is still no uniform standard. In order to avoid the huge costs of bioequivalence studies and unnecessary duplication of a large number of similar studies, it is necessary to develop a standard. Recently (1991) A bioavailability / bioequivalence study conducted by the DIA: Pharmacopoeia