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Research on the method of data analysis for drug development

Research Project

Project/Area Number 05680256
Research Category

Grant-in-Aid for General Scientific Research (C)

Allocation TypeSingle-year Grants
Research Field Statistical science
Research InstitutionScience University of Tokyo

Principal Investigator

YOSHIMURA Isao  Department of Management Science, Faculty of Engineering, Science University of Tokyo, Professor, 工学部, 教授 (30010797)

Co-Investigator(Kenkyū-buntansha) IWASHITA Toshiya  Department of Management Science, Faculty of Engineering, Science University of, 工学部, 助手 (20266919)
NIKI Naoto  Department of Management Science, Faculty of Engineering, Science University of, 工学部, 教授 (10000209)
HAGA Toshiro  Department of Management Science, Faculty of Engineering, Science University of, 工学部, 教授 (40146709)
Project Period (FY) 1993 – 1994
Project Status Completed (Fiscal Year 1994)
Budget Amount *help
¥1,400,000 (Direct Cost: ¥1,400,000)
Fiscal Year 1994: ¥500,000 (Direct Cost: ¥500,000)
Fiscal Year 1993: ¥900,000 (Direct Cost: ¥900,000)
KeywordsMedicine / 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
Research Abstract

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.

Report

(3 results)
  • 1994 Annual Research Report   Final Research Report Summary
  • 1993 Annual Research Report
  • Research Products

    (15 results)

All Other

All Publications (15 results)

  • [Publications] 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)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] 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)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] Yoshimura I.: "Notes on the use of historical controls" Environmental Health Perspectives. 102. 19-23 (1994)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] Hayashi M.: "Statistical analysis of data in mutagenicity assays:Rodent micronucteus assay" Environmental Health Perspectives. 102. 49-52 (1994)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] 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)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] 大野忠夫(編著): "動物実験代替法マニュアル" 共立出版株式会社, 174 (1994)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] Yoshimura I.: "Notes on the Use of Historical Controls" Environmental Health Perspectives. 102. 19-23 (1994)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] Hayashi M.: "Statistical analysis of data in mutagenicity assays : Rodent micronucleus assay" Environmental Health Perspectives. 102. 49-52 (1994)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] 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)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1994 Final Research Report Summary
  • [Publications] Yoshimura I.: "Notes on the Use of Historical Controls" Environmental Health Perspectives. 102. 19-23 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] Hayashi M.: "Statistical analysis of data in mutagenicity assays rodent micronucleus assay" Environmental Health Persepectives. 102. 49-52 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] 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)

    • Related Report
      1994 Annual Research Report
  • [Publications] 大野 忠夫(編著): "動物実験代替法マニュアル" 共立出版株式会社, 174 (1994)

    • Related Report
      1994 Annual Research Report
  • [Publications] 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)

    • Related Report
      1993 Annual Research Report
  • [Publications] 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)

    • Related Report
      1993 Annual Research Report

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Published: 1993-04-01   Modified: 2016-04-21  

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