Research on the method of data analysis for drug development

药物研发数据分析方法研究

• 批准号: 05680256
• 负责人: YOSHIMURA Isao
• 金额: $ 0.9万
• 依托单位: Science University of Tokyo
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for General Scientific Research (C)
• 财政年份: 1993
• 资助国家: 日本
• 起止时间: 1993 至 1994
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-05680256/
• 关键词: Medicine; Statistical Analysis; Preclinical trial; Alternative assay; Draize eye test; ED_<50>; Historical data; 生物統計学; 変量原性試験; 毒性試験

The method of the ED_<50> estimation for 7 altenative assays including Nuclear Red mthod, Cristal Violet method, Colony Formation method was studied. A non-linear least squares method applied on the raw data using a logistic dose-response curve was realized to be useful. Two computor programs based on SAS and C-language was obtained. The programs were applied on the data in a validation study organized by the Society of Alternative Test for Animal Experiments, yielding valuable information.An effective predictor for in vivo Draize eye scores based on some alternative assays was obtained by applying a variable selection method with the criterion of PRESS or its approximately equivalent criterion of doubly adjusted multiple correlation coefficient.Statistical issues on the use of historical controls were investigated and remarks related them were arranged in a report.

对<50>核红法、结晶紫法、菌落形成法等7种替代方法的艾德_（ED）测定方法进行了研究。使用逻辑剂量-反应曲线对原始数据应用非线性最小二乘法是有用的。编制了两个基于SAS和C语言的计算机程序。这些程序应用于动物实验替代试验协会组织的验证研究中的数据，通过应用变量选择方法，以PRESS标准或其近似等效的双重调整的多重相关系数标准，获得了基于一些替代测定的体内Draize眼评分的有效预测因子。对控制措施进行了调查，并在报告中列出了与这些措施有关的评论。

项目成果

Kojima H: "Evaluation of seven alternative assays on the main ingredients in cosmetics as predictors of Draize eye irritation scores" Toxicolgy in vitro. 9 印刷中. (1995)

Kojima H：“评估化妆品中主要成分作为 Draize 眼睛刺激评分的预测因素”，《体外毒理学》9（1995 年）。

吉村 功: "前臨床試験のデータ解析の注意点" 臨床医薬. 9. 983-989 (1993)

Isao Yoshimura：《临床前研究数据分析笔记》《临床医学》9. 983-989 (1993)。

Kojima H.: "Evaluation of seven alternative assays on the main ingriedents in cosmetics as predictors of Draize eye irritation scores" Toxicology in Vitro. 9(発行予定). (1995)

Kojima H.：“作为 Draize 眼睛刺激评分预测因子的化妆品主要成分的七种替代测定的评估”，体外毒理学 9（即将出版）。

吉村 功: "前臨床試験の統計学的側面" 日本統計学会誌. 22. 465-473 (1993)

Isao Yoshimura：“临床前研究的统计方面”，日本统计学会杂志 22. 465-473 (1993)。

Kojima H.: "Evaluation of seven alternative assays on the main ingredients in cosmetics as predictors of Draize eye irritation scores" Toxicolgy in vitro. 9 (to appear). (1995)

Kojima H.：“对化妆品主要成分的七种替代分析作为 Draize 眼睛刺激评分预测因子的评估”体外毒理学。