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Method for predicting clinical pharmacokinetic profiles after oral administration

Research Project

Project/Area Number 22590153
Research Category

Grant-in-Aid for Scientific Research (C)

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

Principal Investigator

YOSHITAKA Yano  京都薬科大学, 薬学部, 教授 (60437241)

Project Period (FY) 2010-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2014: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2013: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2012: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2011: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2010: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Keywords薬物速度論 / モデリング / シミュレーション / 薬物動態 / 予測 / 薬学 / 薬物動態学 / 医療薬学 / 臨床薬理学 / ポピュレーション解析 / コンボリューション / 臨床薬物動態 / 予測分布
Outline of Final Research Achievements

The objective of this study was to develop a modeling and simulation strategy for evaluation of drug absorption profile and for prediction of drug concentration-time curves in human after oral administration. We focused on Tmax and Cmax as easily available pharmacokinetic parameters in animals and human during drug development process, and prediction strategy was constructed by the method of convolution with a use of numerical Laplace transform algorithm. Based on the pharmacokinetic parameters for many drugs in animals and human obtained from literatures, we examined the validity of the prediction strategy and evaluated the predictability. It was suggested that the predictability of the time course profile is dependent on the predictability of Cmax.

Report

(6 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Annual Research Report
  • 2012 Annual Research Report
  • 2011 Annual Research Report
  • 2010 Annual Research Report
  • Research Products

    (7 results)

All 2014 2012 2010 Other

All Journal Article (1 results) (of which Peer Reviewed: 1 results) Presentation (6 results) (of which Invited: 2 results)

  • [Journal Article] Pharmacokinetic/Pharmacodynamic Modeling for Concentration-Dependent Bactericidal Activity of a Bicyclolide, Modithromycin2014

    • Author(s)
      T. Katsube, T. Wajima, Y. Yamano, Y. Yano
    • Journal Title

      J. Pharm. Sci.

      Volume: 103 Issue: 4 Pages: 1288-1297

    • DOI

      10.1002/jps.23897

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Presentation] POPULATION PHARMACOKINETICS OF SM-26000, LIPOSOMAL AMPHOTERICIN B, IN JAPANESE PEDIATRIC PATIENTS WITH INVASIVE FUNGAL INFECTION2012

    • Author(s)
      大畑由佳(企業研究者)
    • Organizer
      American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting 2012
    • Place of Presentation
      Maryland, USA
    • Year and Date
      2012-03-15
    • Related Report
      2011 Annual Research Report
  • [Presentation] これからの臨床薬理M&Sに必要なpharmacometrician養成2010

    • Author(s)
      矢野義孝
    • Organizer
      第31回 日本臨床薬理学会
    • Place of Presentation
      京都国際会議場(京都市)
    • Year and Date
      2010-12-01
    • Related Report
      2010 Annual Research Report
  • [Presentation] 「SM-26000の小児深在性真菌症患者を対象とした製造販売後臨床試験」における母集団薬物動態解析2010

    • Author(s)
      大畑由佳(企業研究者)
    • Organizer
      第26回 Population Pharmacokinetic研究会
    • Place of Presentation
      臨床研究情報センター(神戸市)
    • Year and Date
      2010-10-15
    • Related Report
      2010 Annual Research Report
  • [Presentation] Prediction of Human Pharmacokinetic Profiles Using Data under Drug Development

    • Author(s)
      矢野義孝
    • Organizer
      World Conference on Pharmacometrics
    • Place of Presentation
      韓国(ソウル)
    • Related Report
      2012 Annual Research Report
    • Invited
  • [Presentation] 臨床薬物動態予測のための非臨床動態試験データのモデリング&シミュレーション

    • Author(s)
      矢野義孝
    • Organizer
      薬物動態談話会
    • Place of Presentation
      大阪
    • Related Report
      2012 Annual Research Report
    • Invited
  • [Presentation] ヒトCmax予測値を用いたコンボリューション法による血中濃度推移予測

    • Author(s)
      川邊俊介(矢野義孝)
    • Organizer
      日本薬学会第133年会
    • Place of Presentation
      横浜
    • Related Report
      2012 Annual Research Report

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Published: 2010-08-23   Modified: 2019-07-29  

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