Understanding ICH Guidelines Applicable to Stability Testing
Understanding ICH Guidelines Applicable to Stability Testing
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了解适用于稳定性测试的 ICH 指南
DOI：
10.1007/978-0-387-85627-8_3
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发表时间：
2009
期刊：
影响因子：
--
通讯作者：
Manuel Zahn
中科院分区：
文献类型：
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作者：
Kim Huynh;Manuel Zahn
本章讨论了与稳定性科学相关的人用药品注册技术要求国际协调会议（ICH）指南。它简要介绍了Q1 A是如何启动的。Q1 A（R2）的摘要全面讨论了行业支持和实践的现行法规。在编写本手册时，FDA稳定性指南被撤回;因此，纳入了对指南状态的简要讨论。包括平均动力学温度的讨论，作为理解稳定性试验条件的基础。
This chapter discusses International Conference of Harmonization (ICH) guidelines that are related to the Stability Sciences. It gives a brief history of how the Q1A was initiated. A summary of Q1A(R2) discusses thoroughly the current regulations that the industry supports and practices. While this handbook was being prepared, the FDA Stability Guidance was withdrawn; therefore, a brief discussion of the guidance status has been included. A discussion of mean kinetic temperature is included for a basis of understanding stability testing conditions.