Genotoxicity and Mutagenicity evaluation of impurities using Derek and Sarah software as per ICH M7 guidelines
The ICH M7 guideline helps to identify, categorize, and control DNA reactive, mutagenic, impurities in pharmaceutical products to limit the potential carcinogenic risk related to such impurities. There are series of principles and procedures to consider when generating (Q)SAR assessments aligned with ICH M7 guideline in a regulatory submission. In the absence of adequate experimental data, the results from two complementary (Q)SAR methodologies may be combined to support an initial hazard classification. Our expert toxicologist may help to affirm or reject the predictions followed by extra information from other resources. We use of these principles and procedures to yield a consistent and robust (Q)SAR-based argument to support impurity qualification for regulatory purposes.