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Search results with tag "Ich m7 guideline"
Application Principles ICH M7 Guideline Calculation ...
www.ema.europa.euThe ICH M7 guideline discusses the derivation of acceptable intakes for mutagenic impurities with positive carcinogenicity data, (section 7.2.1) and sta tes: “Compound-specific risk assessments to derive acceptable intakes should be applied instead of the TTC -based [Threshold of Toxicological
ICH Guideline M7R1 Assessment Control DNA Reactive ...
www.ema.europa.euICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk Step 5 Transmission to CHMP July 2017 Adoption by CHMP for release for consultation July 2017 End of consultation (deadline for comments) January 2018