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

从统计学角度替代动物实验的分析方法的验证研究

基本信息

批准号：
07680327
负责人：
YOSHIMURA Isao
金额：
$ 1.41万
依托单位：
Science University of Tokyo
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
1995
资助国家：
日本
起止时间：
1995 至 1996
项目状态：
已结题

项目摘要

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.

在替代动物实验的分析方法的验证研究中，有三个统计学问题需要解决。它们是(1)检测的可靠性和可行性，(2)体内检测的可交替特性，以及(3)体外检测与体内检测的相关性或可预测性。关于(1)，本研究通过对验证研究收集的数据进行统计分析，对日本动物实验替代品协会的验证研究做出了贡献，并通过数据分析得出了结晶紫测试是最可靠的结论。对于(2)，本研究提出了一种数据分析方法，称为最大对比法，用于评估化合物的毒性，识别未观察到毒性的剂量。关于(3)，本研究以预测平方和为标准，成功地确定了一系列最佳预测Draize眼刺激评分的方法。