Olson H, Betton G, Stritar J, Robinson D
Bayer Corporation, W. Haven, CT, USA.
Toxicol Lett. 1998 Dec 28;102-103:535-8. doi: 10.1016/s0378-4274(98)00261-6.
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.
该项目由国际生命科学研究所健康与环境科学研究所（ILSI-HESI）开展，旨在更深入地了解从标准毒理学研究中能够预测出临床试验期间出现的各类人类毒性（HTs）的程度。截至目前，一个由131种药物制剂组成的多公司数据库基于临床开发过程中鉴定出的具有一种或多种已证实的HTs的化合物。这些中期结果支持动物模型对人类毒性的真阳性预测率为69%，并且非啮齿动物（狗、灵长类动物）物种的研究结果很有可能识别出许多治疗类别的HTs。对更大数据库的持续评估可能会对新毒理学方法的识别产生影响，并可能导致非临床研究设计的优化和评估的改进。
