Success and Accuracy in Genotoxicity and Carcinogenicity Testing: An FDA Perspective
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Success and Accuracy in Genotoxicity and Carcinogenicity Testing: An FDA Perspective
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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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Timothy Robison
genotoxicity and carcinogenicity testing
genotoxicity
carcinogenicity
regulatory guidelines
cell genotoxicity assays
genotoxic impurities
in vitro mammalian cell genotoxicity assays
QSAR data
mutagenic activity
