摘要
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.
作者
刘倩
南楠
马玲云
牛剑钊
许鸣镝
LIU Qian;NAN Nan;MA Lingyun;NIU Jianzhao;XU Mingdi(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《药物评价研究》
CAS
2019年第12期2377-2381,共5页
Drug Evaluation Research
基金
国家“重大新药创制”科技重大专项资助项目(2017ZX09101001)
关键词
体外结合试验
磷结合剂
胆酸结合剂
生物等效性试验
仿制药质量和疗效一致性评价
In vitro binding test
phosphate binding agent
bile acid binding agent
bioequivalence
consistency evaluation of generic drug products