The Predictivity of the Toxicity of Pharmaceuticals in Humans From Animal Data—An Interim Assessment

  • Publication Date :
  • Publication Type : Journal Article
  • Author(s) : Olson H, Betton G, Stritar J, Robinson D
  • Journal Name : Toxicology Letters

Toxicology Letters. 1998;102:535-538

Abstract: This project was undertaken by the International Life Sciences Institute's Health and Environmental Sciences Institute (ILSI-HESI) to develop an improved understanding of the extent to which various types of human toxicities (HTs) manifested during clinical trials could be predicted from standard toxicology studies. A multi-company database of 131 pharmaceutical agents to-date was based on compounds with one or more demonstrated HTs identified during clinical development. These interim results support a true positive prediction rate of animal models for human toxicity of 69%, and also that study results from non-rodent (dog, primate) species have good potential to identify HTs from many therapeutic classes. The continuing assessment of a larger database may have impact on the identification of new toxicology methodologies, and may lead to optimization of non-clinical study designs and improved assessments.

To view the full citation, click here.

Contact Us

Health and Environmental Sciences Institute (HESI)
Phone: +1-202-659-8404
Fax: +1-202-659-3859

740 15th Street NW, Suite 600
Washington, DC 20005

Stay Informed

Sign up for our monthly e-newsletter.