摘要
遗传毒性研究是药物非临床安全性评价的重要内容,与致癌性、生殖毒性研究密切相关。遗传毒性试验目的是检测受试物的致突变性,预测受试物的致癌性,对受试物的遗传毒性潜在性进行全面评价是药物进入临床试验及上市的重要环节。遗传毒性标准试验组合包含体内和体外试验,测试终点多样,本文从人员资质、实验室管理、给药制剂、实验系统、试验实施关键阶段等方面阐述遗传毒性评价研究的关注点,为遗传毒性研究实施提供借鉴。研究机构应严格遵循药物非临床研究质量管理规范(good laboratory practice for nonclinical laboratory studies, GLP)实施评价工作,不断提高遗传毒性试验质量。
Genotoxicity evaluation is an important part of the non-clinical safety evaluation of drugs,which is closely related to carcinogenicity and reproductive toxicity.The purpose of genotoxicity test is to detect the mutagenicity and potential carcinogenic effects of the test articles,and a comprehensive assessment of their genotoxicity potential is an important link for drugs to enter clinical trials and marketing.The standard test battery for genotoxicity includes in vivo and in vitro tests with a variety of endpoints.In this paper,the concerns of genotoxicity evaluation were expounded from the personnel qualification,laboratory management,dose formulation,test system,key stages of experimental implementation,etc.,so as to provide reference for the conducting of genotoxicity study.The safety assessment should be conducted in strict compliance with the good laboratory practice for nonclinical laboratory studies(GLP)by the testing facility,and the quality of genotoxicity tests should be improved constantly.
作者
高梅
张蓉
徐娜
陈凯
王欣欣
张岱州
GAO Mei;ZHANG Rong;XU Na;CHEN Kai;WANG Xin-xin;ZHANG Dai-zhou(Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China;Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100022,China;Center for Inspection of Jiangsu Medical Products Administration,Nanjing 210008,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2024年第14期1417-1423,共7页
Chinese Journal of New Drugs
基金
山东省人工噬菌体药物技术创新中心资助项目(ZY2019003)。
关键词
药物
遗传毒性
体内
体外
非临床研究质量管理规范
drug
genotoxicity
in vivo
in vitro
good laboratory practice for nonclinical laboratory studies
