浅谈rasH2-Tg小鼠短期致癌性试验的设计要点  

Key points in study design of the short-term carcinogenicity with rasH2-Tg mice model

作　　者：张佳珊 张冬霞 宫田田 张素才 ZHANG Jia-shan;ZHANG Dong-xia;GONG Tian-tian;ZHANG Su-cai(JOINNLaboratories(Beijing),Beijing Key Laboratory for Biological Products Safety Evaluation,Beijing 100176;School of Pharmacy,China Pharmaceutical University,Nanjing 211198)

机构地区：[1]北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京100176 [2]中国药科大学药学院,南京211198

出　　处：《中南药学》2024年第8期2100-2107,共8页Central South Pharmacy

基　　金：国家重点研发计划资助项目(No.2021YFC2302505);建设医药科技成果转移转化公共服务平台项目(No.2021019611)。

摘　　要：rasH2-Tg小鼠是当前转基因替代模型中应用最广泛的短期致癌性试验模型小鼠,对遗传阳性致癌物和非遗传阳性致癌物均敏感,且自发肿瘤率较低。目前国内外相关指导原则还没有针对该转基因小鼠致癌性试验的详细设计要求,本文通过汇总并分析了2013—2022年在美国获批上市且采用该转基因小鼠进行的51个新药的致癌性试验申报资料,并结合实际工作经验对试验设计要点进行整理论述,为国内新药致癌性试验的开展提供参考。The rasH2-Tg bioassay is a wildly used transgenic alternative model in short-term carcinogenicity test,which is sensitive to gene-positive or negative carcinogens.No details have been found about experimental requirements for the model in relevant guidelines at home and abroad.This review summarized the information of rasH2-Tg test batteries from 51 new drug application reviews evaluated by FDA/CDER from 2013 to 2022,and described the key points in the trial design combined with practical experience.The review aims to support the development of carcinogenicity trials of transgenic alternative models for the use of new drugs in China.

关 键 词：致癌性试验 rasH2-Tg小鼠 替代小鼠模型 

分 类 号：R965[医药卫生—药理学]