GeneTox: A Pivotal Part of Safety Assessment

Genotoxicity testing is the basic requirement for the regulatory submission of drug candidates and other regulated chemicals. Historically, GeneTox data have been used in hazard identification to evaluate if the test material causes DNA damage with the results only in form of Binary outcome (Yes or No). Most recently, with the approval of ICH S2(R1) and ICH (M7) guidelines, GeneTox data is used for risk assessment and risk management. An in vitro positive data can be followed up to de‑risk using assays like Transgenic Rodent (TGR), Comet, and Pig‑a. This webinar highlights the standard battery and the follow-up assays, and the approaches for the selection of these assays. Frontage Laboratories offers a standard battery of GeneTox assays, and our experts can guide our clients for the follow-up assays, if and when needed.

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