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Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches - PharmaFacts
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Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches

Guidances - FDA Guidances

UCM079235.pdfalt
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079235.pdf