Get reliabe predictions of biological activity for when there’s no mutagenicity data available.

(Quantitative) Structure Activity Relationship ((Q)SAR) predictions are an important part of hazard characterization in the context of ICH M7 (R1) application. If there is no mutagenicity data available, (Q)SAR models can be used to make predictions of biological activity based on chemical structure of actual and potential impurities of pharmaceuticals as well as degradation products.

For the assessment of potential mutagenicity for impurities, ICH M7 (R1) recommends that two complementary (Q)SAR models are used, one expert rule-based and the other a statistical-based model. The FDA has indicated a preference for output from two in silico systems: one rule based (e.g. Derek Nexus) and one statistical (e.g. Leadscope).

We provide in silico analysis coupled with expert knowledge to produce reports compliant with the requirements for ICH M7. Our professional partner has an excellent track record for the successful submission of in silico reports to regulatory agencies.

For more information

please contact our Senior Toxicologist Dr. Heidi Becker.

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