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M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018