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.
Individuals from the following areas can benefit from this webinar: Pharmaceutical, Flavor and Fragrance, Tobacco, Chemical, Regulatory, Academia, Consultants
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Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21 percent in 2013. In other words, “efforts to remove unsafe agents earlier in the development cycle are paying off.” Much of this success in small molecules relates to careful and methodical work done well before the Investigational New Drug (IND) application.
In this infographic, we explore the current landscape of ligand binding assays (LBAs) and critical reagents through comprehensive survey questions.
In this Q&A, Nan Zhang MD PhD, Vice President of Global Central Lab and Biomarker Services at Frontage, speaks on the role of analytical and central laboratories in providing accurate laboratory data and seamless logistics services.