Regulatory science research on drug develpment, review, and post-marketing regulation
| Project/Area Number |
23590603
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical sociology
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| Research Institution | Kagawa University (2013)
Nagasaki University (2011-2012) |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
SHIMAZAWA Rumiko 九州大学, 病院ARO次世代医療センター, 特任准教授(常勤) (00411083)
TODAKA Kouji 九州大学, 病院ARO次世代医療センター, 准教授 (40398061)
YOKOI Hideto 香川大学, 医学部附属病院, 教授 (50403788)
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| Project Period (FY) |
2011 – 2013
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| Project Status |
Completed (Fiscal Year 2013)
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| Budget Amount *help |
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2013: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2012: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2011: ¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
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| Keywords | レギュラトリー・サイエンス / 医薬品評価学 / 臨床試験 / 臨床開発 / 個別化医療 / 適応外使用 / テキストマイニング / ナレッジベース / 添付文書 / リスクコミュニケーション / 国際情報交換 / アメリカ合衆国 / 連合王国 / 新薬承認審査 / データマイニング / ドラッグ・ラグ |
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| Research Abstract |
[1] Shimazawa R, Ikeda M. Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan. J Clin Pharm Ther 2014;39:210-214 [2] Shimazawa R, Ikeda M. Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom, and Japan. J Clin Pharm Ther 2013;38:468-475 [3] Shimazawa R, Ikeda M. Safety information in drug labeling: a comparison of the United States, the United Kingdom, and Japan. Pharmacoepidemiol Drug Saf 2013;22:306-18 [4] Shimazawa R, Ikeda M. Br J Clin Pharmacol 2012;75:1365-7 [5] Shimazawa R, Ikeda M. Clin Ther 2012;34:2104-16 [6] Shimazawa R, Ikeda M. Health Policy 2012;107:312-317 [7] Shimazawa R, Kusumi I, Ikeda M. J Clin Pharm Ther [9]Shimazawa R, Ikeda M. Lancet 2011;378:486.2012;37:348-351. [8] Shimazawa R, Ikeda M. Ann Intern Med 2011;155:135-6. [10] Shimazawa R, Ikeda M. Intern Med 2011;50:1565-1568.[11] Shimazawa R, Ikeda M. Br J Clin Pharmacol 2011;71:473-475
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Report
(4 results)
Research Products
(21 results)
