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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 the interpretation of positives in these tests and how people in the industry can overcome these challenges to avoid potential delays in drug development.
The second part of the interview focuses on dealing with genotoxic impurities, from the regulatory perspective. This covers how QSAR data can be used to predict potential mutagenic activity and how this will help the industry. Dr. Robison also talks about what changes he thinks need to be made at an industry level to overcome problems in dealing with genotoxic impurities, together with his thoughts on the future of addressing genotoxic impurities from a regulatory perspective and what regulatory changes he anticipates for the future.