Addressing Genetic Toxicology Across Drug Development: Regulatory and Scientific Perspectives
Genetic toxicology remains one of the most critical and consequential endpoints in the safety evaluation of pharmaceuticals. Recent scientific discussions within the toxicology community have highlighted how genetic toxicology assessments are strategically applied across early screening, regulatory development, and emerging impurity-related challenges. These discussions underscore evolving regulatory expectations, advances in testing strategies, and practical pathways…
