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administration plannning of antibody drugs based on PK/PD analysis

Research Project

Project/Area Number 24790145
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Research InstitutionGunma University

Principal Investigator

ARAKI TAKUYA  群馬大学, 医学(系)研究科(研究院), 准教授 (00568248)

Research Collaborator YAMAMOTO Koujirou  
NAGANO Daisuke  
NAKAMURA Hironori  
Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2014: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2013: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2012: ¥2,990,000 (Direct Cost: ¥2,300,000、Indirect Cost: ¥690,000)
Keywords抗体医薬 / 個別化医療 / 薬物療法 / 質量分析 / 成分分析 / 抗体医薬品 / 抗抗体医薬品抗体 / バイオマーカー / 二次無効
Outline of Final Research Achievements

Antibody drugs (ADs) show remarkable benefits, while resistance to AD or infusion reaction, which are associated with expression of anti-AD antibody, are often induced. In this study, we tried to develop simple process to establish the method for quantitation of unknown proteins and find factors of resistant to AD therapy.
Blank serum samples and serum spiked with ADs were reduced, alkylated and digested by trypsin and analyzed by LC-TOF MS. Several specific precursor ion peaks for AD were determined from total ion chromatogram data using principal component analysis (PCA). Then, those peaks were analyzed by LC-MS/MS. Using purified peak with SPE process, we could detect ADs in serum with sufficiently lower limit of quantification. Our method is applicable to analyze other ADs and unknown substances such as anti-AD antibody, because it does not require structural determination of target substance. Now we have been assessing factors affecting the efficacy of AD using clinical samples.

Report

(4 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (5 results)

All 2014 2013 Other

All Presentation (5 results)

  • [Presentation] Establishment of method for quantitation of antibody drugs using LC-MS/MS with biomarker analytical technique2014

    • Author(s)
      Hironori Nakamura, Takuya Araki, Daisuke Nagano, Koujirou Yamamoto
    • Organizer
      6th International Conference on Advanced Micro‐Device Engineering
    • Place of Presentation
      Kiryu, Gunma, Japan
    • Year and Date
      2014-12-05
    • Related Report
      2014 Annual Research Report
  • [Presentation] Quantification of an antibody drug, infliximab, in human blood using biomarker analysis technique2014

    • Author(s)
      Hironori Nakamura, Takuya Araki, Daisuke Nagano, Koujirou Yamamoto
    • Organizer
      International Congress of Therapeutic Drug Monitoring & Clinical Toxicology European Conference
    • Place of Presentation
      Prague, Czech Republic
    • Year and Date
      2014-08-28 – 2014-08-30
    • Related Report
      2014 Annual Research Report
  • [Presentation] LC-MS/MS method for the quantification of infliximab in human blood2013

    • Author(s)
      Hironori Nakamura, Takuya Araki, Tomonori Nakamura, Koujirou Yamamoto
    • Organizer
      13th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT)
    • Place of Presentation
      Salt Lake City, USA
    • Related Report
      2013 Research-status Report
  • [Presentation] Development approach using LC-MS/MS and biomarker analytical technique for the quantification of infliximab in human blood2013

    • Author(s)
      Hironori Nakamura, Takuya Araki, Koujirou Yamamoto
    • Organizer
      第7回次世代を担う若手医療薬科学シンポジウム
    • Place of Presentation
      仙台
    • Related Report
      2013 Research-status Report
  • [Presentation] Establishment of prediction method for clinical efficacy of antibody drugs using LC-MS/MS with biomarker searching technique

    • Author(s)
      Hironori Nakamura, Takuya Araki, Koujirou Yamamoto
    • Organizer
      5th InternationalConference on Advanced Micro‐Device Engineering
    • Place of Presentation
      Kiryu, Gunma, Japan
    • Related Report
      2013 Research-status Report

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Published: 2013-05-31   Modified: 2019-07-29  

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