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:

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Bound Version $5 / €4 $5 / €4 buy now


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