How does evidence-based decision making assist Expert Review? 

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.