Chen J J
Division of Biometry and Risk Assessment, Food and Drug Administration, Jefferson, Arkansas 72079, USA.
Stat Med. 1996 Jun 15;15(11):1217-25. doi: 10.1002/(SICI)1097-0258(19960615)15:11<1217::AID-SIM229>3.0.CO;2-4.
This paper presents test procedures for testing of the overall dose effect at every tumour type site simultaneously in a chronic animal carcinogenicity bioassay. I derive global tests of the tumour prevalence rates and the tumour onset rates using the generalized estimating equations approach. The test is based on the model of a common dose effect alternative. I used the logistic regression model for simultaneous testing of non-lethal tumours, and the Poly-3 test for testing of mixtures of lethal or non-lethal tumours of different types/sites. An application illustrating the proposed tests concerns analysis of a carcinogenicity experiment designed to study the dose response of hepatocellular and bladder tumours to 2-acetylaminofluorene (2-AAF) exposure.
本文介绍了在慢性动物致癌性生物测定中同时测试每种肿瘤类型部位总体剂量效应的测试程序。我使用广义估计方程方法推导肿瘤发生率和肿瘤起始率的全局检验。该检验基于共同剂量效应替代模型。我使用逻辑回归模型同时测试非致死性肿瘤，并使用Poly-3检验测试不同类型/部位的致死性或非致死性肿瘤混合物。一个说明所提出检验的应用涉及对一项致癌性实验的分析，该实验旨在研究肝细胞和膀胱肿瘤对2-乙酰氨基芴（2-AAF）暴露的剂量反应。
