For 25 years, MultiCASE has developed cheminformatic tools for evaluating toxicity and metabolism potential for chemicals. Throughout that time, the MultiCASE ICH M7 Suite has become a robust collection of models and tools available to perform ICH M7 compliant risk assessments.
The ICH M7 guideline states both expert rule-based and statistical (Q)SAR methodologies are required to assess the DNA reactivity potential of a query chemical. The guideline also provides a provision to apply expert knowledge, which can be used to evaluate the results from the QSAR methodologies to achieve a clear positive, or negative, conclusion.
This presentation will explore how evidence based decision making can assist the expert to reach a better and informed decision for ICH M7 class assignment and regulatory submission.
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