Research on the method of data analysis for drug development
| Project/Area Number |
05680256
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| Research Category |
Grant-in-Aid for General Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Research Field |
Statistical science
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| Research Institution | Science University of Tokyo |
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Principal Investigator |
YOSHIMURA Isao Department of Management Science, Faculty of Engineering, Science University of Tokyo, Professor, 工学部, 教授 (30010797)
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| 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)
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| Project Period (FY) |
1993 – 1994
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| Project Status |
Completed (Fiscal Year 1994)
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| 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)
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| Keywords | 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 |
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| 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.
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Report
(3 results)
Research Products
(15 results)
