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ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

Short Title:
ICH Q11
Origin/Publisher:

Document Type:
ICH Guideline
Content:
This guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD).

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