上市药品稳定性数据桥接问题探究
Review of Marketed Drugs Stability-Test Data Bridging
DOI: 10.12677/HJMCe.2018.64012, PDF,    科研立项经费支持
作者: 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
关键词: 药品；稳定性试验；有效期；数据桥接；Drug； Stability-Test； Expiration Dating Period； Data-Bridging
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。
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.
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. https://doi.org/10.12677/HJMCe.2018.64012

参考文献

[1] 陈海峰. 药物建立有效期的考虑要点[J]. 中国新药杂志, 2009, 18(19): 1831-1834.
[2] 宁黎丽, 李雪梅. 化学药物稳定性研究的试验方法和设计[J]. 中国新药杂志, 2010, 19(12): 1013-1016.
[3] ICH (1998) Ethnic Factors in the Acceptability of Foreign Clinical Data. International Conference on Harmonization Tripatite Guidence E5, The US Federal Register, 83, 31790-31796.
[4] 桑国卫. 新药临床研究中的桥接试验[J]. 中国处方药, 2003(2): 50-53.
[5] 杨颖. 改善药物稳定性的方法综述[J]. 中国药师, 2007, 10(2): 138-139.
[6] 郝甜媛. 晶型转化对药物稳定性的影响研究进展[J]. 现代药物与临床, 2013, 28(3): 457-460.
[7] 周肖寅, 等. 氟氯西林钠多晶型药物稳定性考察[J]. 中国医院药学杂志, 2011, 31(16): 1386-1388.
[8] 黄财顺, 李宝才, 向诚. 人工胃肠液模型在药物稳定性研究中的应用现状[J]. 天然产物研究与开发, 2015, 27(10): 1836-1841.
[9] Liu, D. 药物稳定性实验方案设计研究的国际化规范[J]. 中国药科大学学报, 2005, 36(3): 284-288.