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Int J Toxicol 2019 Dec 26 [Epub ahead of print]

Predictivity/translatability of toxicities observed in nonclinical toxicology studies to clinical safety outcomes in drug development: case examples.

Stagg NJ, Ghantous HN, Roth R, Hastings KL


Nonclinical toxicology studies are conducted to characterize the potential toxicities and establish a safe starting dose for new drugs in clinical studies, but the question remains as to how predictable/translatable the nonclinical safety findings are to humans. In many cases, there is good concordance between nonclinical species and patients. However, there are cases for which there is a lack of predictivity or translatability that led to early termination of clinical studies due to unanticipated toxicities or early termination of programs before making it to the clinic due to unacceptable nonclinical toxicities assumed to be translatable. A few case examples of safety findings that are translatable versus safety findings that are not translatable and why they are not translateable were presented as a symposium at the 38th Annual Meeting of the American College of Toxicology in Palm Springs, California, and are discussed in this article.

Category: Journal Article, Review
PubMed ID: #31875744 DOI: 10.1177/1091581819894281
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2019-12-29 Entry Last Modified: 2020-01-26