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Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk - Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes

Short Title:
ICH M7(R1)
Origin/Publisher:

Content:
This guideline provides useful information regarding the acceptable limits of known mutagenic impurities.

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