GLP药物安全性评价中组织病理学检查流程的探讨  

Histopathological examination process in GLP evaluation of drug safety

作　　者：孙昌华 祝清芬 

机构地区：[1]山东省食品药品检验研究院药物安全评价中心,济南250101

出　　处：《中国新药杂志》2016年第9期981-984,共4页Chinese Journal of New Drugs

摘　　要：临床前安全性评价的主要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。临床前安全性评价的质量直接关系到人类用药的安全,药品非临床研究质量管理规范(good laboratory practice of drug,GLP)的建立就是为了确保实验资料的真实性、完整性及可靠性。毒性病理学研究是药物安全性评价中最重要的研究内容之一,也是临床前安全性评价工作中最基本的环节之一,所以需要建立健全规范、高效的组织病理学检查流程,以促进病理部门的规范化建设。The main purpose of preclinical safety evaluation is to provide scientific basis for human health hazard degree of new drugs,and to predict the risk of listed drugs for human health. Preclinical safety evaluation is directly related to human safety. Good laboratory practice（ GLP） is established to ensure the authenticity,integrity and reliability of the experimental data. Toxic pathology is one of the most important research contents in drug safety evaluation,and is the link of the evaluation work. Thus,it is necessary to improve the standard and efficient organization for inspection process of pathology,then to promote the construction of standardization of the department of pathology.

关 键 词：药品非临床研究质量管理规范 安全性评价 组织病理学 

分 类 号：R99[医药卫生—毒理学]