ABOUT THIS PROJECT
The ICH M7 guidance provides a specification for the use of in silico models for evaluating the genotoxicity of impurities in pharmaceuticals. The guidelines support the combined use of consensus models based on statistical-based (Q)SAR and expert rule-based computational toxicology combined with an expert opinion to support a regulatory submission. Leadscope and DC have established a partnership providing a market leading consulting service to execute the modelling and reporting requirements of such a regulatory submission. It is based on the regulatory-accepted Leadscope software developed in close collaboration with the US FDA.