Chapter 3
Evaluation of long-term carcinogenicity assays
3.1 Principles
The purpose of a long-term carcinogenicity study is to evaluate the tumorigenic potency of a compound when it is administered to rodents for most of their life span [109, 270]. An FDA guideline describes study design and statistical analysis [14]. But, more in detail the US National Toxicology Program proposed a balanced design with a control and three dose groups with sample sizes of 50 animals for each sex and related statistical tests [9]. The primary objective is to identify a dose-dependent trend. Commonly the Cochran–Armitage test and its modifications are used. However, because of its limitations (see Section 2.1.6 for details), Williams-type tests (or just Dunnett-type ...
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