致癌試驗的目的是考察藥物在動物體內(nèi)的潛在致癌作用，從而評價其可能對人類的相關(guān)風(fēng)險，是非臨床藥物安全性評價的主要內(nèi)容之一。嚙齒動物致癌試驗的結(jié)果與人類安全性評估的相關(guān)性經(jīng)常引起爭議，可能需要做進(jìn)一步的研究來探討其作用方式，以幫助確定是否存在對人類的潛在致癌性。當(dāng)嚙齒動物致癌試驗出現(xiàn)陽性結(jié)果時，可能需要進(jìn)行進(jìn)一步的毒性病理學(xué)研究探討其作用機(jī)制，來評估與人類的相關(guān)性。簡要介紹動物致癌試驗結(jié)果與人類相關(guān)性的必要性、致癌試驗基于作用方式與人類風(fēng)險評估無關(guān)的腫瘤、致癌試驗基于作用方式與人類風(fēng)險評估可能無關(guān)的腫瘤，以期為我國非臨床藥物致癌試驗的結(jié)果分析和藥物評價研究提供一定參考。

The objective of carcinogenicity study is to identify the potential carcinogenesis in animals and to assess the relevant risks in humans of drugs, which is one of the major components of nonclinical safety evaluation of drugs. The relevance between the results of rodent carcinogenicity studies and assessment of human safety are often the cause for debate. Further toxicologic pathology research may be needed to investigate the mode of action, which contribute to confirm the presence or the lack of potential carcinogenesis for humans. When rodent carcinogenicity study shows positive results, further studies may be needed to investigate the mechanism of action to assess the correlation with humans. This article gives brief introduction of the need for evaluating the relevance between study results in animals and human safety in carcinogenicity study, some tumors in carcinogenicity study not relevant to humans, some tumors in carcinogenicity study possibly not relevant to humans based on mode of action, in order to provide some references for the result analysis of nonclinical carcinogenicity study and drug evaluation research in China.

江蘇省新藥一站式高效非臨床評價公共服務(wù)平臺建設(shè)項目（BM2021002）