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2.4.3.1 Question 3.1
Оглавление| Question | Answer |
|---|---|
| Should nonmutagenic, carcinogenic impurities be controlled according to ICH M7? | No. Carcinogens that are negative in the bacterial reverse mutation assay do not have a DNA reactive mechanism of carcinogenicity and therefore are not in scope of the ICH M7 guidance (e.g. acetamide and hydroxylamine). |
This Q&A assists stakeholders understand that when impurities are negative in the Ames test but contained carcinogenic effects, they do not need to be controlled within the scope of the ICH M7 and should be controlled according to the ICH Q3A/Q3B guidelines. In such cases the carcinogenicity data may serve as the point of departure for calculation of an appropriate PDE as described in the ICH Q3C guideline.
