ICH Q11: Development and Manufacture of Drug Substances

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ICH Q11 Cover Image

U.S. Department of Health and Human Services,
Food and Drug Administration,
Center for Drug Evaluation and Research(CDER),
Center for Biologics Evaluation and Research (CBER)

The ICH Q11 mini-handbook is used in association with several ISPE training courses:

Formats Member Price Nonmember Price  
Bound Version $5 / €4 $5 / €4 buy now

Last Update: 18 June 2013


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