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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In this paper, we provide practical advice on how to usher a small molecule through preliminary toxicology testing and derive information required to design IND-enabling studies. Indeed, with a rigorous exploratory toxicity program, sponsors can mitigate the risk of unexpected challenges and optimize the Good Laboratory Practice (GLP) study plan.
The purpose of this study was to develop a better model to improve the quality of ddPCR assay validation, involving how to improve the reliability of accuracy, precision, and sensitivity.
This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and thermally, oxidatively, and photolytically unstable active pharmaceutical ingredient (API) for ophthalmic application, specifically for the reduction of intraocular pressure (IOP) and to provide neuroprotection.