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of this guideline can be used if warranted for ich guideline m (r ) on assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk ema/chmp/ich/ / page / impurities in excipients that are used for the first time in a drug product and are chemically

at the end of a standard lifespan for the species taking into account the frequency of that tumor type in control animals ttc-based threshold of toxicological concern-based uds unscheduled dna synthesis unep united nations environmental programme us epa united states environmental protection agency...

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf

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