Search results with tag "Mutagenic"
Guideline on assessment and control of DNA reactive ...
www.ema.europa.euof toxicological concern (TTC) for genotoxic carcinogens, resulting in an acceptable intake of 0.025 µg/kg bw/day. For target animals, the approaches to derive acceptable intakes are specified in section 8. Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
ICH M7: Assessment and Control of Mutagenic Impurities - …
pqri.orgM7 to new marketing applications that do not include Phase 2B/3 clinical trials is not expected until 36 months after ICH publication of M7 (e.g., new dosage forms, or new DMFs supporting generic drug applications, may follow pre-M7 guidance until July 2017). • The 36 month implementation period is also
Q&A on the CHMP Guideline on the Limits of Genotoxic ...
www.ema.europa.eui) If an impurity triggers a mutagenic structural alert, will a negative result in an Ames test on the impurity (conducted to regulatory acceptable standards) be sufficient to conclude