Remove Bioassay Remove Clinical Trials Remove Genetic Engineering Remove Genotoxicity
article thumbnail

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

This stage is more highly regulated and consists of both preclinical testing and clinical trials. These guidelines are in place to evaluate a pharmaceutical’s potential health risks, including genotoxicity, immunotoxicity, and reproductive toxicity. In practice, this was typically conducted in rats and mice.