主题：【讨论】强迫降解测试

原文由 ghost555 发表:
As for those active substances described in official pharmacopoeia monograph,stress testing is mandatory or not ?
官方药典中所述有效成分，是否需要进行压力测试？

according to CPMP/QWP/122/02,rev corr:
rev corr什么意思？
If there are named under "purity test" and/or "section on impurities", and the active substances completely meets the requirements of Pharmacopoeia, then no stress testing is needed.

therefore, I think, for those active substances with purity test or impurities itmes described in pharmocopoeia, in my idea, it's unnecessary to conduct such study.right or not? But why so many customers ask for those data? thanks in advance.

原文由 ghost555 发表:
stress testing 是指forced degradation studies

rev corr　是指revision corrected.

原文由 redanqi 发表:

原文由 ghost555 发表:
stress testing 是指forced degradation studies

rev corr　是指revision corrected.

不好意思，没有见过这个forced degradation studies的相关知识，想知道这个跟压力测试有没有什么关系？

原文由 poorlittle 发表:
corr　是否有可能是 corrigendum  (勘误表) ?

原文由 ghost555 发表:
a) When an active substance is described in an official pharmacopoeia monograph and fully meets its requirements no data are required on the degradaiton products if they are named under the headings "purity test" and/or "section on impurities".