Salsburg D
Fundam Appl Toxicol. 1983 Jan-Feb;3(1):63-7. doi: 10.1016/s0272-0590(83)80174-2.
Currently used designs for carcinogenic bioassay (lifetime feeding studies in mice or rats using maximum tolerated doses of the test compound) are examined to see if they meet the requirements of a bioassay, using the results of 170 compounds reported on as of June, 1980, by the National Cancer Institute. It is concluded that the lifetime feeding study has never been subjected to proper validation as an assay for human carcinogens. When an attempt is made to validate it on the basis of these reported studies and those in the literature, it appears to lack acceptable specificity and sensitivity. It is suggested that a drastically different design is needed and that such redesigning of the assay will require proper validation.
利用美国国立癌症研究所截至1980年6月报告的170种化合物的结果，对目前用于致癌生物测定的设计（在小鼠或大鼠中使用最大耐受剂量的受试化合物进行终生喂养研究）进行了检查，以确定它们是否符合生物测定的要求。得出的结论是，终生喂养研究从未作为一种检测人类致癌物的方法进行过适当的验证。当试图根据这些报告的研究以及文献中的研究对其进行验证时，它似乎缺乏可接受的特异性和敏感性。建议需要一种截然不同的设计，并且这种测定方法的重新设计将需要适当的验证。
