Validation study of assays alternative to animal experiments from a statistical viewpoint

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There are three statistical issues to be addressed in the validation study of assays alternative to animal experiments. They are (1) the reliability and feasibility of assays, (2) the features of in vivo tests to be alternated, and (3) the degree of correlation or the predictability of in vitro assays to in vivo tests. Regarding (1), this reserch contributed to the validation study sonducted by the Japanese Society of Alternatives to Animal Experiments by statistically analyzing the data collected by the validation study and induced the conclusion that the Crystal Violet Assay is the most reliable one through the data analysis. Regarding (2), this research proposed a method of data analysis, which is referred to as the maximum contrast method, to evaluate toxicity of chemical compounds and identify the dose with no observed toxicity. Regarding (3), this reserch succeeded in identifying a battery of assays optimally predict the Draize eye irritation scores by using the prediction sum of squares as the criterion.