药物遗传毒性研究的考虑要点

Some important considerations in genotoxicity study for pharmaceuticals

遗传毒性研究是药物非临床安全性评价的重要内容。《药物遗传毒性研究技术指导原则》已于2007年10月发布,本文结合该指导原则的起草修订情况,讨论目前药物遗传毒性研究相关问题的一些考虑要点。

Genotoxicity study is one of important parts of non-clinical safety studies for pharmaceuticals. Guidance on genotoxicity study for pharmaceuticals had already been released in October of 2007. Some currently important considerations in genotoxicity study for pharmaceuticals were discussed, combining with background and considerations during the process of composing the guidance.