基于质量源于设计理念的仿制药一致性评价-中国药事.PDF

中国药事 2017年11月 第31卷 第11期 1233 基于质量源于设计理念的仿制药一致性评价 * 徐昕玥，梁毅 （中国药科大学，南京 211198） 摘要 目的： 方法： 为我国仿制药一致性评价工作提出建议。 根据质量源于设计理念的基本原理，借鉴 其在仿制药研发中的实践经验，对我国仿制药一致性评价存在的困难进行分析，提出建议。结果与结 论：基于质量源于设计的理念，可以显著提高仿制药质量和申报材料的规范性，提升监管和审评效率。 借助于质量源于设计的应用，在产品开发阶段就设计好稳定、高效的工艺流程，为临床生物等效性验证 奠定坚实的基础，有利于实现仿制药与原研药质量的“一致性”和“临床替代性”。 关键词： 仿制药；一致性评价；质量源于设计；申报材料；审评效率 R95 A 1002-7777(2017)11-1233-04 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2017.11.002 Consistency Evaluation of Generic Drugs Based on Quality by Design * Xu Xinyue, Liang Yi (China Pharmaceutical University, Nanjing 211198, China) Abstract Objective: To provide suggestions for consistency evaluation in China. Methods: According to the basic principle of “Quality by Design” and its practical experience in the research and development of generic drugs, the difficulties in the consistency evaluation of generic drugs in China were analyzed and some suggestions were put forward. Results and Conclusion: The quality of generic drugs and the standardization of application materials could be significantly improved based on the concept of “Quality by Design”, while the efficiency of regulation and evaluation were promoted. Moreover, a stable and efficient process flow was designed in the product development phase based on the application of “Quality by Design”, and a solid foundation for clinical bioequivalence validation was laid, which is conducive to realizing the “consistency” and “clinical substitution” between generic drugs and original drugs. Keywords ： generic drugs; consistency evaluation; quality by design; application materials; efficiency of evaluation 我国是仿制药大国，作为全球第二大的医药 仿制药的质量参差不齐，与原研药相比还存在一 消费市场，截至2017年9月，我国有7000多家药