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Study on evaluation system for drug cardiotoxicity using on-chip cell-besed analysis and quality examination of generic products of injection

Research Project

Project/Area Number 20590147
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Medical pharmacy
Research InstitutionNagasaki University

Principal Investigator

NAKASHIMA Mikiro  Nagasaki University, 大学院・医歯薬学総合研究科, 教授 (00260737)

Co-Investigator(Kenkyū-buntansha) SASAKI Hitoshi  長崎大学, 病院, 教授 (00170689)
NAKASHIMA Mihoko  長崎大学, 大学院・医歯薬学総合研究科, 准教授 (00301367)
Project Period (FY) 2008 – 2010
Project Status Completed (Fiscal Year 2010)
Budget Amount *help
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2010: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2009: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2008: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Keywords医薬品情報 / 安全性学 / 後発医薬品 / 品質試験 / 毒性試験 / 薬剤応答性 / セロミクス / 動物実験 / 薬剤仮応性 / 薬剤反応性
Research Abstract

We investigated the pharmaceutical quality and safety of generic products of injection using a cultured cell and an experimental animal, and examined the development of the method to evaluate drug cardiotoxicity by an on-chip cardiomyocyte network cell-based analysis. As a result, monitoring of effects on the beating rhythms of the network cells after treatment of agents could us estimate the ionic channel conditions, suggesting that it might be useful as a cell-based measurement system for drug cardiotoxicity. The pharmaceutical quality and safety of generic injections tested in this study were comparable to the innovator injections.

Report

(4 results)
  • 2010 Annual Research Report   Final Research Report ( PDF )
  • 2009 Annual Research Report
  • 2008 Annual Research Report
  • Research Products

    (8 results)

All 2010 2009 2008 Other

All Journal Article (2 results) (of which Peer Reviewed: 2 results) Presentation (6 results)

  • [Journal Article] オンチップ心筋拍動細胞ネットワークを用いた抗不整脈薬の薬物応答性の解析2008

    • Author(s)
      中嶋幹郎、大脇裕一、向江俊彦、梅野繁智、柳原克紀、河野茂、冨永留美、荒木良介、寺薗英之、北原隆志、藤秀人、佐々木均
    • Journal Title

      長崎医学会雑誌 83

      Pages: 59-66

    • NAID

      110007148533

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] オンチップ心筋拍動細胞ネットワークを用いた抗不整脈薬の薬物応答性の解析2008

    • Author(s)
      中嶋幹郎
    • Journal Title

      長崎医学会雑誌 83

      Pages: 59-66

    • NAID

      110007148533

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Presentation] 注射薬の後発医薬品に関する品質及び安全性の評価2010

    • Author(s)
      中嶋幹郎、荒木良介、中嶋弥穂子、中村純三、佐々木均、八坂貴宏
    • Organizer
      第4回日本ジェネリック医薬品学会学術大会
    • Place of Presentation
      さいたま
    • Related Report
      2010 Final Research Report
  • [Presentation] 注射薬の後発医薬品に関する品質及び安全性の評価2010

    • Author(s)
      中嶋幹郎
    • Organizer
      第4回日本ジェネリック医薬品学会学術大会
    • Place of Presentation
      さいたま市
    • Related Report
      2010 Annual Research Report
  • [Presentation] 市販注射薬の先発医薬品と後発医薬品における同等性の検討(2):塩酸リトドリン注射薬の品質比較2009

    • Author(s)
      荒木良介、八坂貴宏、藤井貴玄、田中栄美、向江俊彦、大脇裕一、西田孝洋、中村純三、中嶋弥穂子、中嶋幹郎
    • Organizer
      第26回日本薬学会九州支部大会
    • Place of Presentation
      福岡
    • Related Report
      2010 Final Research Report
  • [Presentation] 市販注射薬の先発医薬品と後発医薬品における同等性の検討(2) : 塩酸リトドリン注射薬の品質比較2009

    • Author(s)
      荒木良介
    • Organizer
      第26回日本薬学会九州支部大会
    • Place of Presentation
      福岡
    • Related Report
      2009 Annual Research Report
  • [Presentation] Effects of antiarrhythmic agents on beating rhythm of cultured cradiomyocyte networks on an agarose microchamberchip2009

    • Author(s)
      Yuichi Ohwaki
    • Organizer
      The Second Asian Symposium on Pharmaceutical Sciences
    • Place of Presentation
      Nagasaki
    • Related Report
      2008 Annual Research Report
  • [Presentation] Effects of antiarrhythmic agents on beating rhythm of cultured cardiomyocyte networks on an agarose microchamber chip

    • Author(s)
      Ohwaki Y、Araki R、Tominaga R、Terazono H、To H、Sasaki H、Nakashima M
    • Organizer
      The Second Asian Symposium on Pharmaceutical Sciences
    • Place of Presentation
      Nagasaki,、Japan
    • Related Report
      2010 Final Research Report

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Published: 2008-04-01   Modified: 2016-04-21  

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