Success and Accuracy in Genotoxicity and Carcinogenicity Testing: An FDA Perspective
Dr. Timothy Robison, Pharmacology/Toxicology Reviewer at the US Food and Drug Administration/CDER, joins Helen Winsor from Pharma IQ, to share the latest insights into achieving successful characterisation of genotoxic impurities and accurate implementation of regulatory guidelines to guarantee a streamlined regulatory submission process. The interview encompasses two key areas. First, in vitro mammalian cell genotoxicity assays, the challenges in dealing with them, the controversy surrounding t...
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