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Providing European organisations services in predictive toxicology to meet ICH M7 regulatory guidelines
The new 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.
Douglas Connect and Leadscope have established a partnership providing a market leading consulting service to execute the modelling and reporting requirements of such a regulatory submission. The regulatory-accepted Leadscope software has been developed in close collaboration with the US FDA to satisfy the requirements for the ICH M7 guidance. More