新药致癌性试验研究注意事项

Critical considerations on new drug carcinogenicity evaluation

药物研发试验筛选出的候选药物进入临床试验前,需进行严格的临床前安全性研究对其潜在毒性进行评价,其中致癌性是安全性评价的主要内容之一。我国致癌性试验也已纳入新药注册的实验项目,啮齿类动物2年期致癌性试验仍被视为致癌性检测的"金标准"。本文总结了啮齿类动物2年期致癌性试验中的常见问题,包括方案设计的标准和建议,以及在实际研究中常见的问题及其可能的解决方案,旨在对啮齿类动物2年期致癌性试验在我国的普遍建立提供有益的参考。

New drug candidates have been coming out of laboratories. This requires rigorous pre-clinical safety evaluation to assess candidates’ potential toxicity before their entering into clinical trials. Carcinogenicity is one of primary topics in safety evaluation field due to the facts that many agents are to be used over long periods of time for some patients in clinic. The carcinogenicity test is also required in new drug registration in China,and the2-year rodent carcinogenicity tests are still considered as ＂golden standard＂for carcinogenicity detection. This article tried to summarize common points based on our carcinogenicity investigation carried out under Good Laboratory Practice（ GLP） conditions. These considerations involve guidelines and suggestion on study design as well as common problems and their possible solutions during the study. We are hoping our experience could benefit the establishment of the 2-year rodent carcinogenicity test in China.