The research on the rationalization and internationalization of the method of data analysis for preclinical experiments

临床前实验数据分析方法的合理化和国际化研究

• 批准号: 09680316
• 负责人: YOSHIMURA Isao
• 金额: $ 1.34万
• 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: 1997
• 资助国家: 日本
• 起止时间: 1997 至 1998
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-09680316/
• 关键词: statistical analysis; pharmacology; toxicology; guideline

This study addressed some statistical issues realized in pre-clinical studies such as the mouse lymphoma assay, transformation assay, and mutagenicity tests.A new method for data analysis was proposed on the mouse lymphoma assay, the result of which will be submitted to the "Mutation Research". The utilization of a Margolin procedure in a validation study on the transformation assay was proposed, the result of which was submitted to the "Alternatives to Laboratory Animals." A proposal for the design and conduct of three in vivo mutagenicity tests was proposed from the viewpoint of statistics, the content was published on the "Mutation Research."

本文针对小鼠淋巴瘤试验、转化试验、致突变试验等临床前研究中存在的一些统计学问题，提出了一种新的小鼠淋巴瘤试验数据分析方法，并将其结果提交给“突变研究”。拟定在转化试验的验证研究中使用Margolin程序，其结果提交给“实验室动物替代品”。从统计学的角度提出了三项体内致突变性试验的设计和实施建议，内容发表在《突变研究》上。"

项目成果

Adler, I.D. et al.: "Recommendations for statistical desigms of in vivo mutagenicity tests with regard to subsequent statistical analysis" Mutation Research. 417. 19-30 (1998)

阿德勒，I.D.