[关键词]
[摘要]
致癌性试验主要用于评价新药的潜在致癌性风险,是安全性评价的重要内容之一。新药人体致癌性风险目前主要依赖临床前试验结果来预测,以形成新药临床试验和上市后的风险控制计划。致癌性试验周期长,花费高,试验设计和结果评价比较复杂,需要研究者和管理机构加强交流沟通。
[Key word]
[Abstract]
The objective of carcinogenicity study is to explore the potential carcinogenicity for new drugs, which is one of the important components of nonclinical safety evaluation. The potency of carcinogenic in human is evaluated with preclinical data, so as to make risk control plan for clinical trial and marketing. Carcinogenicity study usually needs long term with high costs, so it is better to make discussion within researcher and regulatory department.
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[基金项目]