EXPERIMENTAL DESIGN AND DATA ANALYSIS METHODOLOGY FOR ANIMAL EXPERIMENTS

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This project is concerned with statistical methodology issues involved in the design, analysis, and interpretation of laboratory animal experiments, with particular emphasis on two-year carcinogenicity studies. Experimental design issues include the use of the maximum tolerated dose (MTD) and the possible utilization of multiple concurrent control groups in carcinogenicity studies. Research in the area of data analysis has focused on the use of logistic regression techniques to analyze non-fatal tumors, modeling tumor onset distributions, and the assessment of synergistic effects in carcinogenicity testing. Statistical issues affecting the interpretation of carcinogenicity studies include evaluating overall false positive rates and assessing the biological significance of correlated tumor responses.