遗传修饰致癌性动物模型与药物临床前安全性评价

潜在致癌性评价是药物临床前安全性评价的重要内容。传统的大、小鼠致癌性评价方法有周期长、费用高、结果不够准确可靠等局限性;而基于遗传修饰的致癌性动物模型建立的评价方法能大大缩短时间、节省费用,结果可信度高。本文简述了国际上基于遗传修饰动物模型评价新体系的建立过程,我国在该领域的研究现状、存在的差距及对策。

The Application Status of Genetically Modified Carcinogenesis Animal Model in Preclinical Safety Evaluation of Pharmaceuticals

Determining the carcinogenic potential of pharmaceuticals is one of the most important aspects of preclinical safety evaluations.Not only are the conventional 2-year rodents assays protracted,expensive and utilize large numbers of animals,extrapolation of data from such studies to human risk is imprecise. The genetically modified animal models have provided the tools which develop the next generation of carcinogenicity assays,which are time efficient,cost-saving and more precise.This presentation reviews the development of new carcinogenicity testing scheme,the application of genetically modified animal models to preclinical safety evaluations,and the severe status in this field in China and the possible countermeasures.