FAQ
Drugs

Where should the stability protocol and report be presented?

刊登日期:2019-11-13  |  點閱次數 : 1432 次 

The summary and estimated shelf-life of the stability protocol and report should be included in 3.2.P.8.1 (stability summary and conclusion). The post-approval stability protocol and stability commitment should be included in 3.2.P.8.2 (post approval stability protocol and stability commitment). The stability data should be included in 3.2.P.8.3 (stability data).

 

(中文版)


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