在药物安全性评价中毒性病理的操作流程及重要性

临床前安全性评价的目的是提供新药对人类健康危害程度的科学依据,预测上市新药对人类健康的危害程度。临床前安全性评价研究的质量直接关系到人类用药的安全,GLP的建立就是为了确保实验资料的真实、完整和可靠。毒性病理学是毒理学中最为重要的组成部分,也是临床前安全性评价工作中最基本的环节。从毒性病理的整个流程及其重要性方面进行综述。

Operation process and significance of toxicologic pathology in drug safety evaluation

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.