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Statistical Issues in the Design and Analysis of Carcinogenicity Bioassays

A general outline of the statistical issues in the design and analysis of carcinogenicity bioassays is given in this paper. Design issues, such as assignment of animals to treatment groups, dual control groups, duration of study, and the number of animals per group are discussed. Information needed by the biostatistician are listed to facilitate the recording of data by the pathologist. Issues in the analysis of tumor incidence data are given. Use of historical control data is encouraged and discussed.