新药非临床安全性评价中啮齿动物致癌试验结果分析要点  

A retrospective analysis of rodent carcinogenicity test results in the new drug non-clinical safety evaluation

作　　者：张素才 谷玲玲 姚大林 孙云霞 孙涛 ZHANG Su-cai;GU Ling-ling;YAO Da-lin;SUN Yun-xia;SUN Tao(JOINN Laboratories (Beijing),Beijing Key Laboratory for Biological Products Safety Evaluation,Beijing 100176,China;JOINN Laboratories,Inc.(Suzhou)Suzhou 215421,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

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]昭衍苏州新药研究中心有限公司,苏州215421 [3]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2018年第23期2755-2764,共10页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2015ZX000-002).

摘　　要：致癌性研究是药物非临床安全性评价的重要内容,啮齿动物致癌试验的阳性结果在非临床研究中并非罕见,阳性结果的人体相关性判定牵涉到多方利益。本文将汇总2014—2017年FDA批准的17项致癌试验阳性的药物,并结合文献报道和工作经验,从致癌试验的结果分析步骤、阳性结果的判定、人体相关性分析和说明书的描述等几方面提出致癌试验结果分析要点的建议,力求为国内同行、新药申报企业和审评机构提供一些参考。Carcinogenicity study is one of the important components of non-clinical safety evaluation d.uring IND stage and before marketing applications.Positive results of the rodent carcinogenicity tests are not uncommon and the positive results of human relevance involve multiple interests.This article tried to summarize 17drugs of positive results in the carcinogenicity tests which have been approved by US FDA from 2014to 2017.Based on our experience and published literature,some suggestions of carcinogenicity test results are provided in the following aspects,including result analysis procedures,determination of positive results,human relevance analysis,and description of drug labeling.We hope that our practical experience and the retrospective analysis could benefit the domestic industry,Sponsors and regulatory agency in China.

关 键 词：非临床研究 致癌性试验 阳性结果 人体相关性 黑框警告 

分 类 号：R965[医药卫生—药理学]