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标题: ICH Q1A(R2) Stability Testing of New Drug Substances and Products [打印本页]

作者: muding 时间: 2017-11-20 09:40:45 标题: ICH Q1A(R2) Stability Testing of New Drug Substances and Products

ICH Q1A(R2)

Step 4

February 2003

Stability Testing of New Drug Substances and Products

Description:

This Guideline provides recommendations on stabilitytesting protocols including temperature, humidity and trial duration forclimatic Zone I and II. Furthermore, the revised document takes into accountthe requirements for stability testing in Climatic Zones III and IV in order tominimise the different storage conditions for submission of a global dossier.

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作者: admin 时间: 2017-11-20 18:59:07

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