At Frontage, we provide an incorporated approach to GLP regulatory safety pharmacology and early non-GLP discovery pharmacology testing performed according to ICH S7A and S7B compliance from research and development to IND submission.
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In this podcast, we discuss the importance of understanding the role of Safety Pharmacology in your IND filing with special guest: Chris Elders, Study Director at Frontage Laboratories, Inc.
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.
Frontage offers an impressive suite of services to take lead candidate drugs to the IND stage. With Experimur’s acquisition, Frontage now has significantly expanded our range of services, supporting customers’ drug-development programs beyond IND and into NDA-enabling toxicology studies. Frontage has exceptional bioanalytical supporting capabilities for small molecules, large molecules, and biomarkers.