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Research on regulatory environment for pharmaceutical development to improve success rates of new drug development

Research Project

Project/Area Number 20590100
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Drug development chemistry
Research InstitutionThe University of Tokyo

Principal Investigator

ONO Shunsuke  東京大学, 大学院・薬学系研究科, 准教授 (40345591)

Project Period (FY) 2008 – 2012
Project Status Completed (Fiscal Year 2012)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2012: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2011: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2010: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2009: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2008: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywords薬学 / レギュラトリーサイエンス / 医薬品開発 / 臨床試験 / 規制環境 / ドラッグラグ / 成功確率 / 開発戦略 / 製薬 / 市販後安全性 / 医薬品臨床開発 / 市販後安全 / 臨床開発 / 医薬品開発規制 / clinicaltrials. gov
Research Abstract

This research has found a significant positive association between launch delay and success rates of new drug development in the era of global development, which enables us to propose effective R&D policy measures based on the underlying mechanism of profit maximization under uncertainty. We also have found that the global pharmaceutical development and regulatory environment, including implementation of post-marketing surveillance just after launching, seem to have impact on drug safety and dose-setting for the Japanese population. These findings help establish new drug development regulation and policies.

Report

(7 results)
  • 2012 Annual Research Report   Final Research Report ( PDF )
  • 2011 Annual Research Report
  • 2010 Annual Research Report   Self-evaluation Report ( PDF )
  • 2009 Annual Research Report
  • 2008 Annual Research Report
  • Research Products

    (97 results)

All 2012 2011 2010 2009 2008 Other

All Journal Article (43 results) (of which Peer Reviewed: 24 results) Presentation (45 results) Book (5 results) Remarks (4 results)

  • [Journal Article] Analysis of the success rates of new drug development in Japan and the lag behind the US2012

    • Author(s)
      Hirai Y, et al.
    • Journal Title

      Health Policy

      Volume: 104 Pages: 241-246

    • Related Report
      2012 Final Research Report 2011 Annual 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 Annual Research 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 application, regulatory agency,and pharmaceutical companies2012

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

      Journal of Clinical Pharmacy and Therapeutics

      Volume: 37(6) Pages: 657-663

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Differences in Drug Approval Processes of three Regulatory Agencies: A Case Study of Gemtuzumab Ozogamicin2012

    • Author(s)
      Tanimoto T, et al
    • Journal Title

      Investigational New Drugs

      Volume: 31 Issue: 2 Pages: 473-478

    • DOI

      10.1007/s10637-012-9877-8

    • 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 application, regulatory agency, and pharmaceutical companies.2012

    • Author(s)
      Taro Ishibashi
    • Journal Title

      Journal of Clinical Pharmacy and Therapeutics

      Volume: 37 Pages: 657-663

    • Related Report
      2012 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 日本における新薬の臨床開発と承認審査の実績2012

    • Author(s)
      長谷藤信五
    • Journal Title

      医薬産業政策研究所リサーチペーパー

      Volume: 55 Pages: 1-107

    • Related Report
      2012 Annual Research Report
  • [Journal Article] Ethnic Differences in Pharmacokinetics in New Drug Applications and Approved Doses in Japan2011

    • Author(s)
      Fukunaga S, et al.
    • Journal Title

      Journal of Clinical Pharmacology

      Volume: 51(8) Pages: 1237-1240

    • 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)
      Yokota M, et al.
    • Journal Title

      Clinical Pharmacology and Therapeutics

      Volume: 90 Pages: 432-441

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] 新薬の製造販売承認と承認審査を科学する2011

    • Author(s)
      小野俊介
    • Journal Title

      日本薬理学雑誌

      Volume: 138 Pages: 252-255

    • NAID

      10030455870

    • Related Report
      2012 Final Research Report 2011 Annual Research Report
  • [Journal Article] 新医薬品の用量に関する議論を健全に行うためには2011

    • Author(s)
      小野俊介
    • Journal Title

      臨床評価

      Volume: 38(4) Pages: 706-712

    • Related Report
      2012 Final Research Report
  • [Journal Article] 新薬承認の過程と考え方:日本と欧米の比較2011

    • Author(s)
      小野俊介
    • Journal Title

      日本小児臨床薬理学会誌

      Volume: 24(1) Pages: 141-146

    • Related Report
      2012 Final Research Report
  • [Journal Article] ドラッグラグとは何か2011

    • Author(s)
      小野俊介
    • Journal Title

      公衆衛生

      Volume: 75(2) Pages: 90-93

    • Related Report
      2012 Final Research Report
  • [Journal Article] 医薬品開発のグローバル化 がもたらした変化と今後の方向2011

    • Author(s)
      小野俊介
    • Journal Title

      薬理と治療

      Volume: 39(5) Pages: 469-470

    • Related Report
      2012 Final Research Report
  • [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] ドラッグラグとは何か-様々なtradeoffを考える必要がある2011

    • Author(s)
      小野俊介
    • Journal Title

      公衆衛生

      Volume: 75 Pages: 90-93

    • Related Report
      2010 Annual Research Report
  • [Journal Article] Delay in new drug applications in Japan and industrial R&D strategies2010

    • Author(s)
      Hirai Y, et al.
    • Journal Title

      Clinical Pharmacology and Therapeutics

      Volume: 87(2) Pages: 212-218

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

    • Author(s)
      Arnold FL, et al.
    • Journal Title

      Clinical Pharmacology and Therapeutics

      Volume: 87 Pages: 714-720

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Factors associated with Clinical Development and Review Times for New Drugs in Japan2010

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

      Clinical Pharmacology and Therapeutics

      Volume: 88 Pages: 487-491

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Analysis of Pharmaceutical Safety-Related Regulatory Actions in Japan2010

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

      Annals of Pharmacotherapy

      Volume: 44 Pages: 1976-85

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Characteristics of Japanese clinical trials conducted in Japan under the new GCP guideline: Analysis of PMDA audit reports2010

    • Author(s)
      Saito K, et al
    • Journal Title

      Japanese Journal of Clinical Pharmacology and Therapeutics

      Volume: 41(5) Pages: 253-257

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] グローバル開発時代に求められる研究開発政策のあり方2010

    • Author(s)
      小野俊介
    • Journal Title

      循環器専門医誌

      Volume: 18(1) Pages: 68-74

    • Related Report
      2012 Final Research Report 2010 Annual Research Report
  • [Journal Article] 日本の医薬品承認審査の諸課題とドラッグラグ2010

    • Author(s)
      小野俊介
    • Journal Title

      医学のあゆみ

      Volume: 234(9) Pages: 836-839

    • Related Report
      2012 Final Research Report
  • [Journal Article] 配合剤の承認とエビデンス2010

    • Author(s)
      小野俊介
    • Journal Title

      日本病院薬剤師会雑誌

      Volume: 46(11) Pages: 1483-1486

    • Related Report
      2012 Final Research Report
  • [Journal Article] 医薬品評価とレギュラトリーサイエンスの課題2010

    • Author(s)
      小野俊介
    • Journal Title

      ヒューマンサイエンス

      Volume: 21(1) Pages: 22-25

    • NAID

      40016968662

    • Related Report
      2012 Final Research Report
  • [Journal Article] 日本の臨床研究の環境・制度 と薬剤師の関わり方2010

    • Author(s)
      小野俊介
    • Journal Title

      医薬ジャーナル

      Volume: 46(4) Pages: 75-78

    • NAID

      40017085776

    • Related Report
      2012 Final Research Report
  • [Journal Article] Analysis of Pharmaceutical Safety-Related Regulatory Actions in Japan2010

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

      Annals of Pharmacotherapy 44

      Pages: 1976-1985

    • Related Report
      2010 Self-evaluation Report
    • Peer Reviewed
  • [Journal Article] Factors associated with Clinical Development and Review Times for New Drugs in Japan.2010

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

      Clinical Pharmacology and Therapeutics. 88

      Pages: 487-491

    • Related Report
      2010 Self-evaluation Report
    • Peer Reviewed
  • [Journal Article] Delays in New Drug Applications in Japan and Industrial R & D strategies.2010

    • Author(s)
      Hirai Y, et al.
    • Journal Title

      Clinical Pharmacology and Therapeutics. 87

      Pages: 212-218

    • Related Report
      2010 Self-evaluation Report
    • Peer Reviewed
  • [Journal Article] Exploring Differences in Drug Doses Between Japan and Western Countries.2010

    • Author(s)
      Arnold FL, et al.
    • Journal Title

      Clinical Pharmacology and Therapeutics. 87

      Pages: 714-720

    • Related Report
      2010 Self-evaluation Report
    • Peer Reviewed
  • [Journal Article] Clinical Development and Review Times for New Drugs in Japan : Associated Factors2010

    • Author(s)
      石橋太郎
    • Journal Title

      Clinical Pharmacology and Therapeutics

      Volume: 88 Pages: 487-491

    • 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 Delay?2010

    • Author(s)
      山田徹
    • Journal Title

      Annals of Pharmacotherapy

      Volume: 44 Pages: 1976-1985

    • Related Report
      2010 Annual 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] 医薬品評価とレギュラトリーサイエンスの課題2010

    • Author(s)
      小野俊介
    • Journal Title

      HUMAN SCIENCE 21

      Pages: 22-25

    • NAID

      40016968662

    • Related Report
      2009 Annual Research Report
  • [Journal Article] ドラッグ・ラグの 科学的な見方2009

    • Author(s)
      小野俊介, 平井由香
    • Journal Title

      医薬ジャーナル

      Volume: 45(S-1) Pages: 255-259

    • Related Report
      2012 Final Research Report
  • [Journal Article] 医薬品・医療機器行政におけ るリスクマネジメント2009

    • Author(s)
      小野俊介
    • Journal Title

      循環器専門医誌

      Volume: 17(2) Pages: 295-298

    • Related Report
      2012 Final Research Report
  • [Journal Article] A critical review of the determination process by the Japanese reviewing authority in approving the additional efficacy of fludarabine phosphate2009

    • Author(s)
      Narimatsu H, et al.
    • Journal Title

      Journal of Clinical Oncology

      Volume: 27(34) Pages: 236-238

    • Related Report
      2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] Critical review of the determination process by the Japanese reviewing authority in approving the additional efficacy of fludarabine phosphate2009

    • Author(s)
      成松宏人
    • Journal Title

      Journal of Clinical Oncology 27

      Pages: 236-238

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 日本における新医薬品の臨床開発と承認審査2009

    • Author(s)
      石橋太郎
    • Journal Title

      医薬産業政策研究所リサーチペーパー 47

      Pages: 1-94

    • Related Report
      2009 Annual Research Report
  • [Journal Article] 循環器診療におけるリスクマネージメント医薬品・医療機器行政におけるリスクマネージメント2009

    • Author(s)
      小野俊介
    • Journal Title

      循環器専門医 17

      Pages: 295-298

    • Related Report
      2009 Annual Research Report
  • [Journal Article]2009

    • Author(s)
      日本臨床腫瘍学会(編集)
    • Journal Title

      新臨床腫瘍学改訂第2版(南江堂)

      Pages: 188-192

    • Related Report
      2009 Annual Research Report
  • [Journal Article] ドラッグ・ラグの科学的な見方2008

    • Author(s)
      小野,俊介
    • Journal Title

      医薬ジャーナル 45

      Pages: 255-259

    • Related Report
      2008 Annual Research Report
  • [Journal Article] Ethnic Differences in Pharmacokinetics in New Drug Applications and Approved Doses in Japan.

    • Author(s)
      Fukunaga S, et al.
    • Journal Title

      J Clinical Pharmacology in press

    • Related Report
      2010 Self-evaluation Report
    • Peer Reviewed
  • [Presentation] 新薬の臨床開発と承認審査期間-5か年戦略最終年度の2011年調査結果を踏まえ-2012

    • Author(s)
      長谷藤信五他
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Year and Date
      2012-11-30
    • Related Report
      2012 Final Research Report
  • [Presentation] effect sizeと関係する試験デザイン等の要素に関する探索的な研究2012

    • Author(s)
      福永悟史他
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Year and Date
      2012-11-30
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬承認申請における参考 資料と製薬企業の申請戦略の関係2012

    • Author(s)
      樋爪太郎他
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Year and Date
      2012-11-29
    • Related Report
      2012 Final Research Report
  • [Presentation] 「重大な副作用」の記載順位の決定に関する分析2012

    • Author(s)
      熊澤景介他
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Year and Date
      2012-11-29
    • Related Report
      2012 Final Research Report
  • [Presentation] 新医薬品の審査状況に関する アンケート2012

    • Author(s)
      今泉恵他
    • Organizer
      第2回レギュラトリーサイエンス学会
    • Place of Presentation
      東京
    • Year and Date
      2012-09-03
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬の臨床開発と承認審査 期間-グローバル開発品目が増加しつつある 2010年調査結果を踏まえて-2011

    • Author(s)
      福島達也他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-03
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬の承認審査期間に関連 する因子と企業の申請戦略に関する分析2011

    • Author(s)
      石橋太郎他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-03
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬の臨床開発と承認審査期間2011

    • Author(s)
      福島達也, 他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-03
    • Related Report
      2011 Annual Research Report
  • [Presentation] 新薬の承認審査期間に関連する因子と企業戦略に関する分析2011

    • Author(s)
      石橋太郎, 他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-03
    • Related Report
      2011 Annual Research Report
  • [Presentation] 日本人被験者対象の第1相試験における初回投与量-抗悪性腫瘍剤2011

    • Author(s)
      児玉庸夫, 他
    • Organizer
      第32回日本臨床薬理学会年会
    • Place of Presentation
      浜松
    • Year and Date
      2011-12-03
    • 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
      2012 Final 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] 臨床用量・曝露レベルと無毒性量・曝露レベルからみた医薬品の安全性評価.抗悪性腫瘍薬(肺がん)2011

    • Author(s)
      児玉庸夫, 他
    • Organizer
      第21回日本医療薬学会年会
    • Place of Presentation
      神戸
    • Year and Date
      2011-10-01
    • Related Report
      2011 Annual Research Report
  • [Presentation] 新医薬品の審査状況に関する アンケート2011

    • Author(s)
      今泉恵他
    • Organizer
      第1回レギュラトリーサイエン ス学会
    • Place of Presentation
      東京
    • Year and Date
      2011-09-02
    • Related Report
      2012 Final Research Report
  • [Presentation] 新医薬品の承認審査状況に関するアンケート2011

    • Author(s)
      今泉恵, 他
    • Organizer
      第1回レギュラトリーサイエンス学会
    • Place of Presentation
      東京
    • Year and Date
      2011-09-02
    • Related Report
      2011 Annual Research Report
  • [Presentation] 臨床試験とレギュラトリーサイエンス2011

    • Author(s)
      小野俊介
    • Organizer
      第58回日本実験動物学会総会
    • Place of Presentation
      東京
    • Year and Date
      2011-05-27
    • Related Report
      2011 Annual Research Report
  • [Presentation] 世界の臨床開発の実施状況 と日本の位置づけ2011

    • Author(s)
      山中洋介他
    • Organizer
      日本薬学会第131年会
    • Place of Presentation
      静岡
    • Year and Date
      2011-03-30
    • Related Report
      2012 Final Research Report
  • [Presentation] 世界の臨床開発の実施状況と日本の位置づけ2011

    • Author(s)
      山中洋介, 他
    • Organizer
      日本薬学会第131年会
    • Place of Presentation
      静岡
    • Year and Date
      2011-03-30
    • Related Report
      2010 Annual Research Report 2010 Self-evaluation 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)
      小西康司他
    • 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
      2012 Final Research 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)
      横田昌史他
    • 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
      2012 Final Research Report 2010 Annual Research Report
  • [Presentation] 医薬品の副作用報告に関連する要因の定量的研究2010

    • Author(s)
      山田徹他
    • 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
      2012 Final Research 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)
      高本幹大他
    • 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
      2012 Final Research 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, 他
    • Organizer
      第31日本臨床薬理学会年会
    • Place of Presentation
      京都
    • Year and Date
      2010-12-01
    • Related Report
      2010 Self-evaluation Report
  • [Presentation] 新薬承認までの過程:日本と 欧米の比較2010

    • Author(s)
      小野俊介
    • Organizer
      第37回日本小児臨床薬理学会
    • Place of Presentation
      東京
    • Year and Date
      2010-11-03
    • 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)
      福永悟史他
    • 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
      2012 Final 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 他
    • 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
      2012 Final Research Report 2009 Annual 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)
      石橋太郎他
    • 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
      2012 Final Research Report 2010 Self-evaluation 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] 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)
      山田徹他
    • 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
      2012 Final Research Report 2010 Self-evaluation 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
  • [Presentation] 日本の臨床研究の環境・制度と薬剤師の関わり方(シンポジウムS14「臨床研究をデザイン(サポート)する薬剤師となるために,医療薬学の創る未来 科学と臨床の融合」)2009

    • Author(s)
      小野俊介
    • Organizer
      第19回日本医療薬学会年会
    • Place of Presentation
      長崎
    • Year and Date
      2009-10-25
    • Related Report
      2009 Annual Research Report
  • [Presentation] 日本の医薬品行政の全体像とその特徴(総会特別シンポジウム2「泌尿器科医療と医薬品審査」)2009

    • Author(s)
      小野俊介
    • Organizer
      第97回日本泌尿器科学会総会
    • Place of Presentation
      岡山
    • Year and Date
      2009-04-17
    • Related Report
      2009 Annual Research Report
  • [Presentation] 新薬臨床開発におけるドラッグラグの合理性2009

    • Author(s)
      工藤広平他
    • Organizer
      日本薬学会第129回年会
    • Place of Presentation
      京都
    • Year and Date
      2009-03-26
    • Related Report
      2012 Final Research Report
  • [Presentation] 新薬臨床開発におけるドラッグラグの合理性2009

    • Author(s)
      工藤,広平
    • Organizer
      日本薬学会年会(第129年会)
    • Place of Presentation
      京都
    • Year and Date
      2009-03-26
    • Related Report
      2008 Annual Research Report
  • [Presentation] Regulatory perspective on global development2009

    • Author(s)
      小野,俊介
    • Organizer
      第73回日本循環器学会総会・学術集会
    • Place of Presentation
      大阪
    • Year and Date
      2009-03-21
    • Related Report
      2008 Annual Research Report
  • [Presentation] 三極における医療用医薬品の承認用量の多様性の分析2008

    • Author(s)
      Frank Arnold他
    • Organizer
      第29回日本臨床薬理学会年会
    • Place of Presentation
      東京
    • Year and Date
      2008-12-06
    • Related Report
      2012 Final Research Report
  • [Presentation] 日本のドラッグラグの定量的分析2008

    • Author(s)
      平井由香他
    • Organizer
      第29回日本臨床薬理学会年会
    • Place of Presentation
      東京
    • Year and Date
      2008-12-05
    • Related Report
      2012 Final Research Report 2010 Self-evaluation Report
  • [Presentation] 日本のドラッグラグの定量的分析:新薬承認申請の遅れに関係する開発要因2008

    • Author(s)
      平井,由香
    • Organizer
      日本臨床薬理学会年会(第29回)
    • Place of Presentation
      東京
    • Year and Date
      2008-12-05
    • Related Report
      2008 Annual Research Report
  • [Presentation] 新薬承認申請における参考資料と製薬企業の申請戦略の関係

    • Author(s)
      樋爪太郎
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2012 Annual Research Report
  • [Presentation] 「重大な副作用」の記載順位の決定に関する分析

    • Author(s)
      熊澤景介
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2012 Annual Research Report
  • [Presentation] 新薬の臨床開発と承認審査期間

    • Author(s)
      長谷藤信五
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2012 Annual Research Report
  • [Presentation] effect sizeと関係する試験デザイン等の要素に関する探索的な研究

    • Author(s)
      福永悟史
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2012 Annual Research Report
  • [Presentation] 日本人被験者対象の第1相試験における初回投与量

    • Author(s)
      佐藤健治
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2012 Annual Research Report
  • [Presentation] 新医薬品の審査状況に関するアンケート

    • Author(s)
      今泉恵
    • Organizer
      第2回レギュラトリーサイエンス学会
    • Place of Presentation
      東京
    • Related Report
      2012 Annual Research Report
  • [Book] 創薬化学の魅力2009

    • Author(s)
      小野俊介他
    • Publisher
      廣川書店
    • Related Report
      2012 Final Research Report
  • [Book] 新臨床腫瘍学2009

    • Author(s)
      小野俊介他
    • Publisher
      南江堂
    • Related Report
      2012 Final Research Report
  • [Book] 医薬品評価概説2009

    • Author(s)
      小野俊介, 他
    • Publisher
      東京化学同人
    • Related Report
      2010 Self-evaluation Report
  • [Book] 新臨床腫瘍学2009

    • Author(s)
      小野俊介, 他
    • Publisher
      南江堂
    • Related Report
      2010 Self-evaluation Report
  • [Book] 医薬品評価概説:有用な医薬品開発のための2009

    • Author(s)
      内山充(監修)
    • Total Pages
      263
    • Publisher
      東京化学同人
    • Related Report
      2009 Annual Research Report
  • [Remarks] 東京大学大学院薬学系研究科医薬品評価科学教室

    • URL

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

    • Related Report
      2012 Final Research Report
  • [Remarks]

    • URL

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

    • Related Report
      2011 Annual Research Report
  • [Remarks] 研究室ホームページ

    • URL

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

    • Related Report
      2010 Self-evaluation Report
  • [Remarks]

    • URL

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

    • Related Report
      2010 Annual Research Report

URL: 

Published: 2008-04-01   Modified: 2019-07-29  

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