Success and Accuracy in Genotoxicity and Carcinogenicity Testing: An FDA Perspective



Pharma IQ
09/21/2010

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...
TO READ THE FULL STORY