Application of microdosing technique for therapeutic drug monitoring

• Project/Area Number: 22590137
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: Gifu Pharmaceutical University
• Principal Investigator: HIRONO Kazuyuki 岐阜薬科大学, 薬学部, 薬学部 (90057365)
• Co-Investigator(Kenkyū-buntansha): NAKAMURA Mitsuhiro 岐阜薬科大学, 薬学部, 准教授 (30433204) ; SAJIKI Hironao 岐阜薬科大学, 薬学部, 教授 (50275096)
• Project Period (FY): 2010 – 2012
• Project Status: Completed (Fiscal Year 2012)
• Budget Amount: ¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000); Fiscal Year 2012: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000); Fiscal Year 2011: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000); Fiscal Year 2010: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
• Keywords: マイクロドーズ / 薬物血中濃度モニタリング / LC-MS/MS / MALDI-TOF/TOF / 重水素化内部標準物質

Research Abstract

The phase 0 microdose (MD) study appears as a new viable concept in the clinical research of the drug development activity. We synthesized clobazam-d2as the internal standard using a H-D exchange reaction. We developed several analytical methods (LC-MS/MS, LCMS-IT-TOF, MALDI-TOF/TOF) using clobazam-d2for the MD study. MD technique may be applied to pharmacokinetic parameter prediction in the therapeutic drug monitoring.

Research Products

• [Journal Article] 抗てんかん薬のHPLC 分析に適した生体試料前処理法および分析カラムの評価
  • Author(s): 大森智史,川合麻未, 中村光浩, 谷口和美,井口和弘, 伊藤善規, 臼井茂之, 平野和行
  • Journal Title: ぎふ病薬
• [Presentation] Simultaneous determination of sphingolipid metabolites by LC/MS-IT-TOF using Kinetex Core-ShellHPLC column. (2012)
  • Author(s): M. Nakamura, et al
  • Organizer: 53rd International Conference on the Bioscience of Lipids
  • Place of Presentation: Banff, Canada
• [Presentation] Simultaneous determination of sphingolipid metabolites by LC/MS-IT-TOF using Kinetex Core-Shell HPLC column (2012)
  • Author(s): Nakamura, M., et al.
  • Organizer: 53rd International Conference on the Bioscience of Lipids
  • Place of Presentation: Banff, Canada
• [Presentation] Measurement of clobazam in plasma by the matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. (2011)
  • Author(s): 川合麻未, 中村光浩,井口和弘,臼井茂之,門口泰也,土屋照雄, 佐治木弘尚, 平野和行
  • Organizer: 第21回日本医療薬学会年会
  • Place of Presentation: 神戸
• [Presentation] MALDI-TOF MS による血漿中クロバザムの測定 (2011)
  • Author(s): 川合麻未, 中村光浩,井口和弘,臼井茂之,門口泰也,土屋照雄, 佐治木弘尚, 平野和行
  • Organizer: 日本薬学会第131 年会
  • Place of Presentation: 静岡
• [Presentation] Measurement of clobazam in plasma by the matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (2011)
  • Author(s): 川合麻未, ら
  • Organizer: 第21回日本医療薬学会年会
  • Place of Presentation: 神戸
• [Presentation] MALDI-TOF MSによる血漿中クロバザムの測定 (2011)
  • Author(s): 川合麻未
  • Organizer: 日本薬学会第131年会
  • Place of Presentation: 静岡