In Silico Insider

Information for Computational Toxicologists

Welcome to In Silico Insider, a bi-weekly info-Blog that you’ll surely want to bookmark.

We invite you to step inside our online community, where our subject matter experts will share important insights about key issues facing our industry. From regulatory updates to industry innovations and scientific best practice, we hope this becomes a regular destination for you.

Tools to support the Carcinogenic Potency Categorization Approach (CPCA)

As you may be aware, the US Food and Drug Administration (FDA), the European Medicines Agencies (EMA), and Health Canada have recently released a major update on N-nitrosamine impurities in human medicinal products supporting the categorical prediction of N-nitrosamine potency. The new approach is referred to as the Carcinogenic Potency Categorization Approach (CPCA) and is…

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Assessing whether In Silico models are fit-for-purpose

In Silico methods are used to predict a toxicological outcome directly from the chemical structure. In general, the state-of-the-art is to use multiple methodologies in combination with an expert review of prediction results.1 These approaches are used either as a direct replacement for an in vitro or in vivo assay or a part of a…

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