论文部分内容阅读
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。
The purpose of preclinical safety assessment is to provide a scientific basis for the degree of harm to human health caused by new drugs and to predict the degree of harm to human health caused by new drugs marketed. The quality of preclinical safety evaluation research is directly related to the safety of human medication. The purpose of GLP is to ensure the authenticity, integrity and reliability of experimental data. Toxicology is the most important component of toxicology and the most basic part of pre-clinical safety evaluation. The whole process of toxicological pathology and its importance are reviewed.