我国临床前药物致癌试验转基因动物模型研究进展  

Research Progress of Transgenic Animal Models for Preclinical Carcinogenicity Study of Drugs in China

作　　者：杨艳伟[1] 刘甦苏[2] 吕建军[1] 王三龙[1] 张素才 柳全明 范昌发[2] Yang Yanwei;Liu Susu;Lv Jianjun;Wang Sanlong;Zhang Sucai;Liu Quanming;Fan Changfa(Beijing Key Laboratory for Safety Evaluation of Drugs,National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing 100176,China;Institute for Laboratory Animal Resources,National Institutes for Food and Drug Control,Beijing 102609,China;JOINN Laboratories(China)Co.,Ltd.,Beijing 100176,China)

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心、药物非临床安全评价研究北京市重点实验室,北京100176 [2]中国食品药品检定研究院实验动物资源研究所,北京102609 [3]北京昭衍新药研究中心股份有限公司,北京100176

出　　处：《中国药事》2019年第8期880-886,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:综述我国临床前药物致癌试验转基因动物模型研究进展。方法:介绍致癌试验常用转基因动物模型的构建、利用转基因动物模型开展致癌试验的优势、国际认可及国际监管机构新药申报中的应用、国内外致癌试验相关指导原则、我国开展基于转基因动物致癌试验面临的困境以及转基因动物模型构建的最新进展。结果与结论:基于转基因动物模型的致癌试验具有诸多优势也是目前国际趋势,在我国建立临床前药物致癌试验转基因动物模型非常必要。Objective: To introduce the research progress of transgenic animal models for preclinical carcinogenicity study of drugs in China. Methods: The establishment of commonly used transgenic animal models for preclinical carcinogenicity study of drugs, advantages of the carcinogenicity study using transgenic animal models, international recognition and new drug application submitted to international regulatory agencies,guidelines for carcinogenicity study at home and abroad, dilemma of carrying out carcinogenicity study based on transgenic animal models in China, as well as latest progress of establishing transgenic animal models for carcinogenicity study in China were introduced. Results and Conclusion: The carcinogenicity study based on the transgenic animal models has many advantages and is now an global trend. It is necessary to establish transgenic animal models for preclinical carcinogenicity study of drugs in China.

关 键 词：临床前 药物 致癌试验 转基因动物模型 研究进展 

分 类 号：R95[医药卫生—药学] R994.232