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Eudralex Volume 3 ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Short Title:
EMA/CHMP/ICH/83812/2013
Origin/Publisher:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This Guideline describes a general framework and practical approaches on how to deal with genotoxic impurities in new drug substances and drug products.
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