浅析以体外结合试验作为评价指标的仿制药生物等效性评价方法

Analysis of bioequivalence evaluation method of generic drugs with in vitro binding test

研究美国食品药品监督管理局(FDA)对以体外结合试验作为生物等效性评价指标的仿制药品种,分析其关键质量属性及生物等效性试验的要求及相关指导原则,并结合文献数据和FDA审评情况总结了需要关注的问题,以期为此类产品的开发提供有益的参考,为我国该类仿制药研发和正在开展的仿制药质量和疗效一致性评价提供技术支持。

To study the requirements and relevant guiding principles of Food and Drug Administration on the generic drugs with in vitro binding test as the bioequivalence evaluation index, and analyze the key quality attributes and bioequivalence test requirements.The bioequivalence guidance issued by FDA and the important considerations of some published articles are summarized. To guide the development and consistency evaluation of these preparations and to have important inspiration of the agreement evaluation of generic drug products in China.