《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》解读

Interpretation of the technical guidelines for the bioequivalence study of generic chemical drugs with pharmacokinetics parameters as the final evaluation index

等效性评价是我国仿制药评审的重要环节,目前等效性评价均以2005年颁布的《化学药物制剂人体生物利用度和生物等效性研究技术指导原则》为依据。2016年3月,国家食品药品监督管理总局发布《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》,本文从分析方法、试验设计、受试者和试验例数、参比制剂等几个方面解读两者的差别。

Equivalence assessment is an important part of Chinese generic drug evaluation. At present, it is based on ＂the technical guidelines for the study of the human bioavailability and bioequivalence of chemical pharmaceutical preparations＂ promulgated in 2005. The technical guideline for the bioequivalence study of generic chemical drugs with pharmacokinetics parameters as the final evaluation index was issued by China Food and Drug Administration in Mar., 2016. In this paper, the differences between the two guidelines are analyzed from several aspects, such as the analysis method, the experimental design, the number of subjects and test cases, and the reference preparation and so on.