探讨药物GLP机构致癌试验中啮齿类动物的临床检查  

Explore GLP Institutions Cancer Trials Rodents in Clinical Examination

作　　者：李春令[1] 刘增祥[1] 刘金鑫 孙昌华 LI Chunling;LIU Zengxiang;LIU Jinxin;SUN Changhua(Shandong Quality Inspection Center For Medical Devices,Jinan 250101 ,China;Shandong Institute for Food and Drug Control,Jinan 250101 ,China)

机构地区：[1]山东省医疗器械产品质量检验中心,济南250101 [2]山东省食品药品检验研究院,济南250101

出　　处：《实验动物科学》2019年第3期74-76,共3页Laboratory Animal Science

摘　　要：致癌性试验主要用于评价新药潜在的致癌性风险,是药物GLP机构安全性评价的重要内容之一。致癌试验的实验周期较长,动物的临床检查是整个试验的一项重要内容,临床检查结果为动物人道终点、临床病理学检测、组织病理学检查提供直接参考依据,本文总结并归纳了2年来大鼠背景数据的临床检查经验,探讨在致癌试验中的应用,以便于为检验人员提供更加全面的动物信息。The carcinogenic test is mainly used to evaluate the potential carcinogenic risk, and it is one of the important contents of the safety evaluation of the drug GLP mechanism. The cycle of carcinogenicity test is very long, and the animal clinical examination involved is an important part of the whole test, and the clinical examination result provide a direct reference for animal humane endpoint, clinical pathology examination, histopathological examination. Thus, we summarized two years of the experience about the rat background data, and explored the application in cancer experiment, so that the experimentalists can get a more comprehensive animal information.

关 键 词：GLP 致癌试验 临床检查 

分 类 号：R73[医药卫生—肿瘤]