ReviewofMarketedDrugsStability-TestDataBridging上市药品稳定性.PDF

Hans Journal of Medicinal Chemistry 药物化学, 2018, 6(4), 85-89 Published Online November 2018 in Hans. /journal/hjmce /10.12677/hjmce.2018.64012 Review of Marketed Drugs Stability-Test Data Bridging Chengyun Wu, Zhen Liu, Quanjiang Nie Sichuan Center for Food and Drug Evaluation, Inspection and Monitoring, SCFDA, Chengdu Sichuan th st st Received: Oct. 8 , 2018; accepted: Oct. 21 , 2018; published: Nov. 1 , 2018 Abstract Object: To review data-bridging of marketed drugs in stability-testing. Methods: Before and after drugs appearing on the market, alteration on entries in the listed drug happened. Data of stabili- ty-test must be bridged. According to the concept of “qualify by design (QbD)”, conditions and process of stability-test data bridging must be valued, based on drug registration regulations and guidelines. Results: Applicable situations and conditions of marketed drug being data-bridged were acquired. Evaluation and bridging of stability-testing data were able to be normalized by this principle. Conclusion: Data-bridging of stability-test is a process of comprehensive evaluation. Keywords Drug, Stability-Test, Expiration Dating Period, Data-Bridging 上市药品稳定性数据桥接问题探究 吴承云，刘 震，聂全江 四川省食品药品审查评价及安全监测中心，四川 成都 收稿日期：2018年10月8 日；录用日期：2018年10月21 日；发布日期：2018年11月1 日 摘 要 目的：探究上市药品的稳定性数据桥接问题。方法：基于质量源于设计的理念，根据药品注册管理法规 及指导原则，对药品上市前后稳定性数据桥接、上市药品变更事项的稳定性数据桥接的条件及过程进行 分析评估。结果：探究出上市药品稳定性数据桥接条件及适用情形，以规范稳定性数据评价与桥接。结 论：稳定性试验数据桥接是综合评估过程。 文章引用: 吴承云, 刘震, 聂全江. 上市药品稳定性数据桥接问题探究[J]. 药物化学, 2018, 6(4): 85-89. DOI: 10.12677/hjmce.2018.64012 吴承云 等 关键词 药品，稳定性试验，有效期，数据桥接 Copyright © 2018 by authors and Hans Publishers Inc. This work is licensed under the Creative