摘要
致癌性实验是药物非临床安全性评价的重要内容,用以考察药物对动物的潜在致癌作用,辅以机制研究等以评价和预测人体长期用药带来的风险。转基因小鼠肿瘤模型的建立为肿瘤研究带来了巨大变化,转基因动物模型也成为致癌性研究的重要选择之一。本文主要参考国际现有指导原则和已上市药品评价资料,概述当前常用转基因动物的特征及其在药物安全性评价中的实际应用情况,为我国致癌性评价中转基因动物的应用提供参考。
Carcinogenicity studies combined with mechanistic studies in nonclinical safety assessment are used to evaluate the potential carcinogenic rick of new therapeutic agents to humans.The generation and characterization of genetically modified mouse models(GMMM) of human cancer have resulted in notable improvement in tumor research.These transgenic mouse bioassays have been used as a substitute for 1 of 2 traditional 2-year carcinogenic bioassays.This review will focus on characteristics of GMMM and their application in nonclinical safety evaluations of pharmaceuticals.
出处
《中国药理学与毒理学杂志》
CAS
CSCD
北大核心
2010年第6期557-561,共5页
Chinese Journal of Pharmacology and Toxicology
基金
十一五重大新药创制科技重大专项资助项目(2008ZX09305-006)~~
关键词
转基因小鼠
致癌性实验
药物评价
临床前
mice,transgenic
carcinogenicity study
drug evaluation,preclinical
