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© 1984 Oxford University Press

research-article

Design of Animal Carcinogenicity Studies for Goodness-of-Fit of Multistage Models

CHRISTOPHER J. PORTIER and DAVID G. HOEL

National Institute of Environmental Health Sciences P.O. Box 12233, Research Triangle Park, North Carolina 27709

Design of Animal Carrinogenkity Studies for Goodness-of-Fit of Multistage Models. PORTIER, C. J., AND HOEL, D. G. (1984). Fundam. Appl. Toxicol. 4, 949–959. The effect of bioassay design changes on the variability of risk estimates in the experimental dose region is investigated. Three-dose designs with a control group and other "usual" designs utilizing 200 animals are studied in detail. Constraints on the minimum power of the linear trend test in proportions are used to eliminate designs with unacceptable power. An acceptable design region is compared to designs aimed at improving the low dose extrapolation. A group of designs acceptable for a range of objectives is proposed.


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