[關鍵詞]
[摘要]
致癌性試驗主要用于評價新藥的潛在致癌性風險,是安全性評價的重要內容之一。新藥人體致癌性風險目前主要依賴臨床前試驗結果來預測,以形成新藥臨床試驗和上市后的風險控制計劃。致癌性試驗周期長,花費高,試驗設計和結果評價比較復雜,需要研究者和管理機構加強交流溝通。
[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.
[中圖分類號]
[基金項目]