Toxicologic Pathology Forum: Opinion on Approaches for Reporting Toxic and Adverse Dose Levels in Nonclinical Toxicology Studies Supporting the Development of Anticancer Pharmaceuticals.
Sign Up to like & getrecommendations! Published in 2023 at "Toxicologic pathology"
DOI: 10.1177/01926233221146937
Abstract: The advancement of an investigational new drug in humans is a significant developmental milestone. In first-in-human (FIH)-enabling toxicology studies, the highest dose without a test article-related adverse effect (no-observed-adverse-effect-level [NOAEL]) serves as the basis for… read more here.
Keywords: toxicology; anticancer pharmaceuticals; dose; pathology ... See more keywords