臨床前安全性評價的目的是提供新藥對人類健康危害程度的科學依據(jù)，預測上市新藥對人類健康的危害程度。臨床前安全性評價研究的質量直接關系到人類用藥的安全，GLP的建立就是為了確保實驗資料的真實、完整和可靠。毒性病理學是毒理學中最為重要的組成部分，也是臨床前安全性評價工作中最基本的環(huán)節(jié)。從毒性病理的整個流程及其重要性方面進行綜述。

Preclinical safety evaluation is to provide scientific basis of the health damage degrees caused by new drugs and to predict the harmful levels to human health caused by the new durgs that are going on sale. The quality of preclinical safety evaluation study is related to the safety for drug using, the set-up of GLP is to assure the reality, integrity, and reliability of the experimental data. Toxicologic pathology is the most important part of toxicology and is the important part of the preclinical safety evaluation. This article provides a review about the operational process and significance of toxicologic pathology in drug safety evaluation.