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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issues guidelines and develops testing strategies for evaluating carcinogenicity along with other risks such as genotoxicity, immunotoxicity, and reproductive toxicity. In practice, this was typically conducted in rats and mice.

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Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Aspartame bioassay findings portend human cancer hazards. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109. Toxicol Lett.

Insulin 52