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Application of pharmacokinetic and pharmacodynamic models constructed for Caucasians to a Japanese population

Research Project

Project/Area Number 24590210
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical pharmacy
Research InstitutionYokohama College of Pharmacy (2013-2014)
Keio University (2012)

Principal Investigator

CHIBA Koji  横浜薬科大学, 薬学部, 教授 (30458864)

Co-Investigator(Kenkyū-buntansha) SUWA Toshio  慶應義塾大学, 薬学部, 教授 (20383664)
MATSUSHIMA Yukiko  慶應義塾大学, 薬学部, 講師 (10618531)
Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2013: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2012: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywords民族差 / CYP2D6 / CYP2C19 / 個体間変動 / モンテカルロシミュレーション / ポピュレーションファーマコキネティクス / 薬物動態 / モデリング / シミュレーション / 母集団薬物動態解析 / 抗菌薬 / CYP2C19 / CYP2C9 / 遺伝子多型 / 低分子ヘパリン / 腎クリアランス
Outline of Final Research Achievements

In this study, Monte Carlo simulation were conducted using population pharmacokinetic (PPK) models for 22 antibiotics which were constructed for mainly Caucasians with adjustment of covariate to Japanese. Reported Japanese Cmax and AUC were compared with simulated values. The results suggested that almost all PPK models for Caucasian were applicable for prediction of Japanese exposure except for some models of cephems, glycopeptides and aminoglycosides presumably due to inappropriate inter-individual variability (IIV) in the models. To determine absorption process after subcutaneous injection of protein drugs, new PPK models for dalteparin were constructed. Ethnic differences between Caucasian and Japanese were accounted for by body weight. Variability of intrinsic clearance reflected by IIV of enzyme activity was estimated for CYP2D6 and CYP2C9. By using the variability, ethnic differences of variability of AUC were successfully predicted.

Report

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

    (25 results)

All 2014 2013 2012 Other

All Journal Article (9 results) (of which Peer Reviewed: 9 results,  Open Access: 1 results,  Acknowledgement Compliant: 1 results) Presentation (16 results) (of which Invited: 12 results)

  • [Journal Article] Prediction of Inter-individual Variability in the Pharmacokinetics of CYP2C19 Substrates in Humans2014

    • Author(s)
      Chiba K, Shimizu K, Kato M, Nishibayashi T, Terada K, Izumo N, Sugiyama Y.
    • Journal Title

      Drug Metabolism and Pharmacokinetics

      Volume: 29 Issue: 5 Pages: 379-386

    • DOI

      10.2133/dmpk.DMPK-13-RG-137

    • NAID

      130004463402

    • ISSN
      1347-4367, 1880-0920
    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] Comparison of Global versus Asian Clinical Trial Strategies Supportive of Registration of Drugs in Japan.2014

    • Author(s)
      Shirotani M, Kurokawa T, Chiba K.
    • Journal Title

      J Clin Pharmacol.

      Volume: 未定 Issue: 7 Pages: 753-764

    • DOI

      10.1002/jcph.273

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials.2014

    • Author(s)
      Shirotani M, Suwa T, Kurokawa T, Chiba K.
    • Journal Title

      J Clin Pharmacol.

      Volume: 未定 Issue: 4 Pages: 438-445

    • DOI

      10.1002/jcph.216

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?2014

    • Author(s)
      Chiba K, Yoshitsugu H, Kyosaka Y, Iida S, Yoneyama K, Tanigawa T, Fukushima T, Hiraoka M.
    • Journal Title

      J Clin Pharmacol.

      Volume: 未定 Issue: 5 Pages: 483-494

    • DOI

      10.1002/jcph.231

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Low-molecular-weight heparin pharmacokinetics: A dual absorption model approach.2013

    • Author(s)
      Abe S, Chiba K, Suwa T.
    • Journal Title

      Int. J. Clin. Pharmacol. Ther.

      Volume: 未定

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Potential factors correlating to the PMDA's decision to waive Japanese Phase 2 and 3 studies for oncology drugs New Drug Application in Japan.2013

    • Author(s)
      Nakajima K, Chiba K, Tsubamoto H, Walsh J, Strawn L, Suwa T.
    • Journal Title

      Invest. New Drugs.

      Volume: 未定 Issue: 4 Pages: 1051-1055

    • DOI

      10.1007/s10637-012-9911-x

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Different Truncation Methods of AUC between Japan and the EU for Bioequivalence Assessment: Influence on the Regulatory Judgment2012

    • Author(s)
      Oishi M, Chiba K, Fukushina T, Tomono Y, Suwa T.
    • Journal Title

      Drug Metabolism and Pharmacokinetics

      Volume: 27 Issue: 6 Pages: 658-662

    • DOI

      10.2133/dmpk.DMPK-12-RG-033

    • NAID

      130004933517

    • ISSN
      1347-4367, 1880-0920
    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Inter-individual Variability of <i>In Vivo</i> CYP2D6 Activity in Different Genotypes2012

    • Author(s)
      Chiba K, Kato M, Ito T, Suwa T, Sugiyama Y.
    • Journal Title

      Drug Metabolism and Pharmacokinetics

      Volume: 27 Issue: 4 Pages: 405-413

    • DOI

      10.2133/dmpk.DMPK-11-RG-078

    • NAID

      130004463263

    • ISSN
      1347-4367, 1880-0920
    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] The pharmacokinetics and pharmacodynamics of PF-00734200, a DPP-IV inhibitor, in healthy Japanese subjects.2012

    • Author(s)
      Muto C, Dai H, Teeter G, Johnson S, Cropp B, Chiba K, Suwa T.
    • Journal Title

      In. J. Clin. Pharmacol. Ther.

      Volume: 50(7) Issue: 07 Pages: 505-509

    • DOI

      10.5414/cp201614

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Presentation] グローバル医薬品開発におけるアジア人第Ⅰ相試験の活用2014

    • Author(s)
      千葉康司
    • Organizer
      第11回DIA日本年会
    • Place of Presentation
      東京
    • Year and Date
      2014-11-17
    • Related Report
      2014 Annual Research Report
    • Invited
  • [Presentation] 生理学的薬物速度論による健康成人および各種特殊集団の薬物動態の予測2014

    • Author(s)
      千葉康司
    • Organizer
      第11回DIA日本年会
    • Place of Presentation
      東京
    • Year and Date
      2014-11-16
    • Related Report
      2014 Annual Research Report
    • Invited
  • [Presentation] Application of antibiotic pharmacokinetic models constructed for Caucasioans to a Japanese population.2014

    • Author(s)
      Hiroki Takuma, Tomohiro Tamai, Kenji Okada, and Koji Chiba
    • Organizer
      The 19th north American ISSX and 29th JSSX meeting
    • Place of Presentation
      San Francisco, USA
    • Year and Date
      2014-10-23
    • Related Report
      2014 Annual Research Report
  • [Presentation] Prediction of ethnic differences using modeling and simulation and impact on the regulatory process.2012

    • Author(s)
      Chiba K.
    • Organizer
      International Conference of the Korean Society of Pharmaceutical Science and Technology
    • Place of Presentation
      Gwangju, Korea
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] 薬物相互作用の回避からコントロールへ2012

    • Author(s)
      千葉 康司
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] 抗体医薬のシステマティックレビュー2012

    • Author(s)
      千葉 康司
    • Organizer
      第9回DIA日本年会
    • Place of Presentation
      東京
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] モデリング&シミュレーション:ドライな環境で論文を書く2012

    • Author(s)
      千葉 康司
    • Organizer
      医薬品開発のためのPopulation Pharmacokinetics / Pharmacodynamics研究会セミナー
    • Place of Presentation
      東京
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] グローバル開発時の日本人第I相試験の意義に関する研究.2012

    • Author(s)
      千葉 康司
    • Organizer
      第19回ヘルスリサーチフォーラム
    • Place of Presentation
      東京
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] PBPK modeling to predict drug interaction of ketoconazole with fesoterodine: Accounting for inhibition of p-gp-mediated renal secretion.2012

    • Author(s)
      Oishi M, Torita Y, Chiba K, Malhotra M, Suwa T.
    • Organizer
      World conference on pharmacometircs
    • Place of Presentation
      Seoul, Korea
    • Related Report
      2012 Research-status Report
  • [Presentation] Virtual clinical trial: Analyses of inter-individual variability in the pharmacokinetics of anionic and cationic drugs secreted into urine.2012

    • Author(s)
      Chiba K, Ogawa K, Kurita S, Suwa T, Sugiyama Y.
    • Organizer
      27th JSSX Annual Meeting
    • Place of Presentation
      千葉
    • Related Report
      2012 Research-status Report
  • [Presentation] モデリング・シミュレーション:文献情報からの変動予測

    • Author(s)
      千葉康司
    • Organizer
      医学統計研究会特定主題シンポジウム2013「臨床評価における用量反応関係の推測」
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] コンピューターの中の臨床試験

    • Author(s)
      千葉康司
    • Organizer
      第15回応用薬理学会シンポジウム
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] Virtual clinical trials: Estimation of intrinsic clearance variabilities of various metabolic enzymes/ transporters and prediction of the exposures variabilities of drugs cleared by multiple systems

    • Author(s)
      Chiba K, Kato M, Sugiyama Y
    • Organizer
      28th JSSX Annual meeting (日本薬物動態学会第28回年会)
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] Update on Asian drug development strategy for ethnic difference

    • Author(s)
      Chiba K
    • Organizer
      Symposium of relevance of drug metabolism and transporter in new drug development in fall international convention of the pharmaceutical society of Korea
    • Place of Presentation
      Osong, Chungchungbuk, Korea
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] 既存母集団薬物動態モデルを用いた日本人臨床試験結果への外的妥当性の検討

    • Author(s)
      玉井智大,松嶋由紀子,黒川達夫,千葉康司
    • Organizer
      第34回日本臨床薬理学会学術総会
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
  • [Presentation] 前臨床の結果および探索的臨床試験の結果を基にして臨床試験の結果を予測する: 個人間変動を考慮した解析

    • Author(s)
      千葉康司
    • Organizer
      第344回CBI(情報計算化学生物)学会研究講演会
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
    • Invited

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

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