The predictivity of the toxicity of pharmaceuticals in humans from animal data - an interim assessment

This project;was undertaken by the International Life Sciences Institute's Health and Environmental Sciences Institute (ILSI-HESI) to develop an impro ved understanding of the extent to which various types of human toxicities (HTs) manifested during clinical trials could be predicted from standard to xicology studies. A multi-company database of 131 pharmaceutical agents to- date was based on compounds with one or more demonstrated HTs identified du ring clinical development. These interim results support a true positive pr ediction rate of animal models for human toxicity of 69%, and also that stu dy results from non-rodent (dog, primate) species have good potential to id entify HTs from many therapeutic classes. The continuing assessment of a la rger database may have impact on the identification of new toxicology metho dologies, and may lead to optimization of non-clinical study designs and im proved assessments. (C) 1998 Elsevier Science Ireland Ltd. All rights reser ved.