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Exploring international differences in approved doses of drugs

Research Project

Project/Area Number 21790109
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeSingle-year Grants
Research Field Drug development chemistry
Research InstitutionThe University of Tokyo

Principal Investigator

KUSAMA Makiko  東京大学, 大学院・薬学系研究科, 講師 (80313146)

Research Collaborator ONO Shunsuke  東京大学, 大学院・薬学系研究科, 准教授 (40345591)
Project Period (FY) 2009 – 2012
Project Status Completed (Fiscal Year 2012)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2012: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2011: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2010: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2009: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywordsレギュラトリーサイエンス / 評価科学 / 民族差 / 人種差 / 医薬品評価 / 医薬品開発 / 規制環境 / 開発戦略
Research Abstract

Japan tended to have lower dose compared to the US, whose doses were similar to that of Europe. Dose differences in Japan and the US could not be accounted for by differences in pharmacokinetics between the two regions. The dose in Japan was more likely to be same to that of the US when non-Japanese firms were the sponsors and when Japanese dose-finding study was not conducted. No relation between dose differences and drug characteristics, such therapeutic class, could be identified. Post-market safety profiles did not show any obvious differences in Japan and the US in spite of dose differences.

Report

(5 results)
  • 2012 Annual Research Report   Final Research Report ( PDF )
  • 2011 Annual Research Report
  • 2010 Annual Research Report
  • 2009 Annual Research Report
  • Research Products

    (37 results)

All 2013 2012 2011 2010 2009 Other

All Journal Article (15 results) (of which Peer Reviewed: 15 results) Presentation (17 results) Book (2 results) Remarks (3 results)

  • [Journal Article] Assessment of statin-associated muscle toxicity in Japan: A cohort study conducted using a claims database and laboratory information2013

    • Author(s)
      Chang CH, Kusama M, Ono S, Sugiyama Y, Orii T, and Akazawa M
    • Journal Title

      BMJ Open

      Volume: 3 Issue: 4 Pages: e002040-e002040

    • DOI

      10.1136/bmjopen-2012-002040

    • Related Report
      2012 Annual Research Report 2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Factors associated with spontaneous reporting of adverse drug reactions in Japan2012

    • Author(s)
      Yamada T, et al.
    • Journal Title

      Pharmacoepidemiology and Drug Safety

      Volume: 22 Issue: 5 Pages: 468-76

    • DOI

      10.1002/pds.3378

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Inclusion of human intravenous study data in new drug applications-impact of the Japanese guidance2012

    • Author(s)
      Imawaka H, Kusama M, Ito K, Ono S, Sugiyama Y
    • Journal Title

      J Pharm Sci

      Volume: 101 Issue: 7 Pages: 2257-63

    • DOI

      10.1002/jps.23135

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Analysis of regulatory review times of new drugs in Japan: Association with characteristics of new drug applications, regulatory agency, and pharmaceutical companies.2012

    • Author(s)
      Taro Ishibashi
    • Journal Title

      J Clin Pharm Ther

      Volume: 37 Issue: 6 Pages: 657-63

    • DOI

      10.1111/j.1365-2710.2012.01363.x

    • Related Report
      2012 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Inclusion of human intravenous study data in new drug applications-Impact of the Japanese guidance-2012

    • Author(s)
      Imawaka Haruo, et al.
    • Journal Title

      Journal of Pharmaceutical Sciences

      Volume: (in press)

    • Related Report
      2011 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan2011

    • Author(s)
      Fukunaga S, Kusama M, Arnold FL, Ono S
    • Journal Title

      J Clin Pharmacol

      Volume: 51 Issue: 8 Pages: 1237-1240

    • DOI

      10.1177/0091270010381500

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Analysis of labeling decisions on therapeutic indication during new drug reviews in Japan2011

    • Author(s)
      Masafumi Yokota, et al.
    • Journal Title

      Clinical Pharmacology & Therapeutics

      Volume: 90 Issue: 3 Pages: 432-441

    • DOI

      10.1038/clpt.2011.134

    • Related Report
      2011 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Ethnic Differences in Pharmacokinetics in New Drug Applications and Approved Doses in Japan.2011

    • Author(s)
      福永悟史
    • Journal Title

      Journal of Clinical Pharmacology

      Volume: (in press)(掲載確定)

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Analysis of pharmaceutical safety-related regulatory actions in Japan: Do tradeoffs exist between safer drugs and launch delay2010

    • Author(s)
      Yamada T, Kusama M, Hirai Y, Arnold FL, Sugiyama Y, Ono S
    • Journal Title

      Ann Pharmacother

      Volume: 44 Issue: 12 Pages: 1976-85

    • DOI

      10.1345/aph.1p153

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Exploring differences in drug doses between Japan and Western countries2010

    • Author(s)
      Arnold FL, Kusama M, Ono S
    • Journal Title

      Clin Pharmacol Ther

      Volume: 87 Issue: 6 Pages: 714-20

    • DOI

      10.1038/clpt.2010.31

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Delays in new drug applications in Japan and industrial R&D strategies2010

    • Author(s)
      Hirai Y, Kinoshita H, Kusama M, Yasuda K, Sugiyama Y, Ono S
    • Journal Title

      ClinPharmacol Ther

      Volume: 87 Issue: 2 Pages: 212-8

    • DOI

      10.1038/clpt.2009.215

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Delays in new drug applications in Japan and industrial R&D strategies2010

    • Author(s)
      平井由香
    • Journal Title

      Clinical Pharmacology Therapeutics 87

      Pages: 212-218

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Exploring differences in drug doses between Japan and Western countries2010

    • Author(s)
      Frank Arnold
    • Journal Title

      Clinical Pharmacology Therapeutics (in press)

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Prediction of the Effects of Genetic Polymorphism on the Pharmacokinetics of CYP2C9 Substrates from In Vitro Data2009

    • Author(s)
      Kusama M、Maeda K、Chiba K、Aoyama A、Sugiyama Y
    • Journal Title

      Pharm Res

      Volume: 26巻 Issue: 4 Pages: 822-835

    • DOI

      10.1007/s11095-008-9781-2

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Prediction of the effects of genetic polymorphism on the pharmacokinetics of CYP2C9 substrates from in vitro data2009

    • Author(s)
      草間真紀子
    • Journal Title

      Pharmaceutical Research 26

      Pages: 822-835

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Presentation] スタチン薬使用における併用薬と筋障害に関する薬剤疫学研究2012

    • Author(s)
      張家嫺、草間真紀子、赤沢学、折井孝男、太田かおり
    • Organizer
      日本薬学会第132 年会
    • Place of Presentation
      札幌
    • Year and Date
      2012-03-31
    • Related Report
      2012 Final Research Report
  • [Presentation] スタチン薬使用における併用薬と筋障害に関する薬剤疫学研究2012

    • Author(s)
      張家嫺
    • Organizer
      日本薬学会年会(第132年会;2012年3月)
    • Place of Presentation
      札幌
    • Year and Date
      2012-03-31
    • Related Report
      2011 Annual Research Report
  • [Presentation] ドラッグラグの直近の状況と発生メカニズムの分析2011

    • Author(s)
      山中洋介, 他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-01
    • Related Report
      2011 Annual Research Report
  • [Presentation] 国内臨床試験における副作用判定率2011

    • Author(s)
      竹内真一郎, 他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-01
    • Related Report
      2011 Annual Research Report
  • [Presentation] 新医薬品の臨床試験で観察された 有害事象の民族差2010

    • Author(s)
      小西康司、草間真紀子、小野俊介、杉山 雄一
    • Organizer
      日本臨床薬理学会年 会第31年会
    • Place of Presentation
      横浜
    • Year and Date
      2010-12-03
    • Related Report
      2012 Final Research Report
  • [Presentation] 新医薬品の臨床試験で観察された有害事象の民族差2010

    • Author(s)
      小西康司
    • Organizer
      第31回日本臨床薬理学会年会
    • Place of Presentation
      京都
    • Year and Date
      2010-12-03
    • Related Report
      2010 Annual Research Report
  • [Presentation] 日本の添付文書改訂の現状と日米の改訂ラグに関する分析2010

    • Author(s)
      高本幹大
    • Organizer
      第31回日本臨床薬理学会年会
    • Place of Presentation
      京都
    • Year and Date
      2010-12-02
    • Related Report
      2010 Annual Research Report
  • [Presentation] 新薬審査における効能効果の決定に関与する要因の分析2010

    • Author(s)
      横田昌史、草間真紀子、小野俊介、杉山 雄一
    • Organizer
      日本臨床薬理学会年会第31年会
    • Place of Presentation
      横浜
    • Year and Date
      2010-12-01
    • Related Report
      2012 Final Research Report
  • [Presentation] 日本の添付文書改訂の現状と日米の改訂ラグに関する分析2010

    • Author(s)
      高本幹大、草間真紀子、小野俊介、杉山 雄一
    • Organizer
      日本臨床薬理学会年会第31年会
    • Place of Presentation
      横浜
    • Year and Date
      2010-12-01
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬審査における効能・効果の決定に関与する要因の分析2010

    • Author(s)
      横田昌史
    • Organizer
      第31回日本臨床薬理学会年会
    • Place of Presentation
      京都
    • Year and Date
      2010-12-01
    • Related Report
      2010 Annual Research Report
  • [Presentation] 医療用医薬品承認用量の日米差に影響する要因の分析2009

    • Author(s)
      Frank Arnold、草間真紀子、福永悟史、小野俊介、杉山雄一
    • Organizer
      日本臨床薬理学会年会第30回
    • Place of Presentation
      京都
    • Year and Date
      2009-12-05
    • Related Report
      2012 Final Research Report
  • [Presentation] 日本人と外国人の薬物動態の違いが日本における承認用量に与える影響2009

    • Author(s)
      福永悟史、Frank Arnold、草間真紀子、小野俊介、杉山雄一
    • Organizer
      日本臨床薬理学会年会第30回
    • Place of Presentation
      京都
    • Year and Date
      2009-12-05
    • Related Report
      2012 Final Research Report
  • [Presentation] 医薬品の安全性措置に関連する要因の定量的研究2009

    • Author(s)
      山田 徹、草間真紀子、平井由香、Frank Arnold、杉山雄一、小野俊介
    • Organizer
      日本臨床薬理学会年会第30回
    • Place of Presentation
      京都
    • Year and Date
      2009-12-05
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬の臨床開発および承認審査の国際化とその成果2009

    • Author(s)
      石橋太郎
    • Organizer
      第30回日本臨床薬理学会年会
    • Place of Presentation
      横浜
    • Year and Date
      2009-12-05
    • Related Report
      2009 Annual Research Report
  • [Presentation] 医療用医薬品承認用量の日米差に影響する要因の分析2009

    • Author(s)
      Frank Arnold
    • Organizer
      第30回日本臨床薬理学会年会
    • Place of Presentation
      横浜
    • Year and Date
      2009-12-05
    • Related Report
      2009 Annual Research Report
  • [Presentation] 新日本人と外国人の薬物動態の違いが日本における承認用量に与える影響2009

    • Author(s)
      福永悟史
    • Organizer
      第30回日本臨床薬理学会年会
    • Place of Presentation
      横浜
    • Year and Date
      2009-12-05
    • Related Report
      2009 Annual Research Report
  • [Presentation] 新医薬品の安全性措置に関連する要因の定量的研究2009

    • Author(s)
      山田徹
    • Organizer
      第30回日本臨床薬理学会年会
    • Place of Presentation
      横浜
    • Year and Date
      2009-12-04
    • Related Report
      2009 Annual Research Report
  • [Book] 新臨床腫瘍学改訂第2版2009

    • Author(s)
      日本臨床腫瘍学会
    • Publisher
      南江堂
    • Related Report
      2012 Final Research Report
  • [Book] 新臨床腫瘍学 改訂第2版2009

    • Author(s)
      日本臨床腫瘍学会(編集)
    • Publisher
      南江堂
    • Related Report
      2009 Annual Research Report
  • [Remarks] 医薬品評価科学講座 研究について

    • URL

      http://www.f.u-tokyo.ac.jp/~regsci/study/themes.html

    • Related Report
      2012 Annual Research Report
  • [Remarks]

    • URL

      http://www.f.u-tokyo.ac.jp/~regsci/index.html

    • Related Report
      2011 Annual Research Report
  • [Remarks]

    • URL

      http://www.f.u-tokyo.ac.jp/~regsci/index.html

    • Related Report
      2010 Annual Research Report

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Published: 2009-04-01   Modified: 2019-07-29  

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