| Project/Area Number |
26460604
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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 |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
嶋澤 るみ子 東海大学, 医学部, 教授 (00411083)
狩野 芳伸 静岡大学, 情報学部, 准教授 (20506729)
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥5,070,000 (Direct Cost: ¥3,900,000、Indirect Cost: ¥1,170,000)
Fiscal Year 2016: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2014: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
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| Keywords | 医薬品情報提供 / 添付文書 / 自然言語処理 / レギュラトリー・サイエンス / 後発品 / 文書解析 / 医薬品評価学 / 必須医薬品 / テキストマイニング / 個別化医療医薬品 / 分子標的薬 / バイオマーカー / 医薬品情報 |
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| Outline of Final Research Achievements |
We demonstrated that our NLP (Natural language processing) system, based on the Kachako platform, helped quantify consistency among SPCs and extracted inconsistencies between generic and original SPCs. Inconsistencies among SPCs for the same drug authorized by the same authority indicate that the existing regulatory scheme does not work effectively in achieving consistency across generic SPCs. However, NLP can address the challenge of checking large numbers of regulatory documents for consistency. Further research on rapidly comparing, correcting, and updating SPCs should contribute toward harmonization across generic SPCs and, ultimately, a centralized online drug information and safety resource.
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