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This chapter explains to the nonpathologist the design, conduct, and interpretation of pathology evaluations of in vivo tests for carcinogenicity. Tumor terminology and other terms used by pathologists in reports of carcinogenicity studies are explained, and the biology of neoplasms is summarized. The design of rodent carcinogenicity studies, their histopathological evaluation, their place in product development, and the application of their results to humans are discussed.
Tumor terminology can be daunting to the nonpathologist; there is far more background noise in carcinogenicity studies than in other types of toxicology study, it can be difficult to apply terminology and diagnostic criteria consistently, and it can be particularly difficult to predict the relevance (or lack of it) to humans of induced rodent neoplasia. However, the same basic principles apply to the design, evaluation, and interpretation of carcinogenicity studies as to other in vivo toxicology studies.
Key wordsCarcinogenicity Rodent Neoplasia Terminology Study design Histopathology evaluation Human relevance
I thank Aida Diaz-Bayon, Kaori Isobe, Stuart Naylor, Petrina Rogerson, and Carol Strepka for their help in writing this chapter. In addition, Aaron Sargeant contributed much of the information on transgenic mouse studies.
Conflict of Interest Statement
The author is an employee of Charles River Laboratories, which supplies rodents for research and carries out many of the in vitro and in vivo safety assessment tests discussed in this chapter. The views expressed are those of the author.
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