2012 Fiscal Year Final Research Report
Research on regulatory environment for pharmaceutical development to improve success rates of new drug development
| Project/Area Number |
20590100
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Drug development chemistry
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| Research Institution | The University of Tokyo |
|---|
Principal Investigator |
ONO Shunsuke 東京大学, 大学院・薬学系研究科, 准教授 (40345591)
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| Project Period (FY) |
2008 – 2012
|
| Keywords | 薬学 / レギュラトリーサイエンス |
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| Research Abstract |
This research has found a significant positive association between launch delay and success rates of new drug development in the era of global development, which enables us to propose effective R&D policy measures based on the underlying mechanism of profit maximization under uncertainty. We also have found that the global pharmaceutical development and regulatory environment, including implementation of post-marketing surveillance just after launching, seem to have impact on drug safety and dose-setting for the Japanese population. These findings help establish new drug development regulation and policies.
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Research Products
(49 results)
