Idänpään-Heikkilä J E
Department of Pharmacology and Toxicology, Institute of Biomedicine, University of Helsinki, Finland.
Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):36-7. doi: 10.1007/BF03190055.
Since 1993, WHO's Division of Drug Management and Policies has been working with drug regulatory authorities from some 20 countries, the pharmaceutical industry--including both research-based as well as generic industry--and academia to set up requirements and specifications for multisource (generic) pharmaceutical products (1). One important area has been the development of an international list of comparator (reference) products for equivalence testing. This has become increasingly necessary as the manufacture, regulatory approvals and use of the generic pharmaceutical products have increased world-wide. In order to save time and resources in product development and to avoid duplication of unnecessary bioavailability testing in humans, it has been suggested that an internationally agreed comparator product system would be helpful. Moreover, any exposure of a human being to a pharmaceutical product in equivalence testing may carry a health risk and may consequently be considered unethical.
自1993年以来，世界卫生组织药品管理与政策司一直与约20个国家的药品监管当局、制药行业（包括创新药企业和仿制药企业）以及学术界合作，制定多源（仿制药）药品的要求和规范(1)。一个重要领域是制定用于等效性测试的对照品（参比制剂）国际清单。随着仿制药在全球范围内的生产、监管批准和使用不断增加，这一点变得越来越必要。为了节省产品开发的时间和资源，并避免在人体中进行不必要的生物利用度测试的重复，有人建议建立一个国际认可的对照品产品体系会有所帮助。此外，在等效性测试中，任何人接触药品都可能带来健康风险，因此可能被认为是不道德的。
