KUSAMA Makiko 草間真紀子

Researcher Number	80313146
Affiliation (based on the past Project Information) *help	2016 – 2019: 東京大学, 大学院薬学系研究科(薬学部), 講師 2014 – 2015: 東京大学, 薬学研究科(研究院), 講師 2013: 東京大学, 大学院薬学系研究科・医薬品評価科学 2012: 東京大学, 大学院・薬学系研究科, 講師 2012: 東京大学, 薬学研究科(研究院), 講師 2009 – 2011: The University of Tokyo, 大学院・薬学系研究科, 助教
Review Section/Research Field	Principal Investigator Medical pharmacy / Drug development chemistry Except Principal Investigator Medical and hospital managemen / Medical pharmacy / Public health/Health science
Keywords	Principal Investigator 臨床薬理試験 / 肝機能障害 / 腎機能障害 / 特殊患者集団 / 用法用量 / 添付文書 / 開発戦略 / 規制環境 / 医薬品開発 / 医薬品評価 … More / 人種差 / 民族差 / 評価科学 / レギュラトリーサイエンス … More Except Principal Investigator 薬剤適正使用 / レセプトデータ / PIMs / 薬剤疫学 / 高齢者 / 健康アウトカム / 新薬アクセス / 国際共同試験 / グローバル開発戦略 / 新薬開発 / グローバル開発 / 有効性 / 新医薬品 / 安全性 / 試験デザイン / 臨床試験 / ドラッグラグ / 新医薬品開発 / NVS / TOFLA / リテラシー / 国際情報交換 / リスクコミュニケーション / Newest Vital Sign / TOFHLA / 健康教育 / 対話型医療 / CFKS / 妊孕性 / Newest Vital Sign (NVS) / HLS-Asia / HLS-14 / 保健医療情報 / ヘルスコミュニケーション / ヘルスリテラシー Less

The pharmacoepidemiology of Potentially Inappropriae Medications among elderly: The analysis of Japanese clinical database.
- Principal Investigator
  
  Akemi Nitta
- Project Period (FY)
  2017 – 2019
- Research Category
  
  Grant-in-Aid for Scientific Research (C)
- Research Field
  
  Medical and hospital managemen
- Research Institution
  Osaka Medical College
特殊な患者集団に対する添付文書の記載と情報に関する研究Principal Investigator
- Principal Investigator
  
  草間真紀子
- Project Period (FY)
  2015 – 2017
- Research Category
  
  Grant-in-Aid for Scientific Research (C)
- Research Field
  
  Medical pharmacy
- Research Institution
  The University of Tokyo
Associations between global drug development strategies and the health outcomes in Japanese patients
- Principal Investigator
  
  Ono Shunsuke
- Project Period (FY)
  2014 – 2018
- Research Category
  
  Grant-in-Aid for Scientific Research (C)
- Research Field
  
  Medical pharmacy
- Research Institution
  The University of Tokyo
Study of developing Japanese version of health literacy scales and fertility knowledge scale in health care
- Principal Investigator
  
  SUGIMORI HIROKI
- Project Period (FY)
  2011 – 2013
- Research Category
  
  Grant-in-Aid for Scientific Research (C)
- Research Field
  
  Public health/Health science
- Research Institution
  Daito Bunka University
Exploring international differences in approved doses of drugsPrincipal Investigator
- Principal Investigator
  
  KUSAMA Makiko
- Project Period (FY)
  2009 – 2012
- Research Category
  
  Grant-in-Aid for Young Scientists (B)
- Research Field
  
  Drug development chemistry
- Research Institution
  The University of Tokyo

All 2017 2015 2014 2013 2012 2011 2010 2009

All Journal Article Presentation

[Journal Article] Organ Impairment-Drug-Drug Interaction Database: A Tool for Evaluating the Impact of Renal or Hepatic Impairment and Pharmacologic Inhibition on the Systemic Exposure of Drugs.2015
- Author(s)
  CK Yeung, K Yoshida, M Kusama, H Zhang, I Ragueneau-Majlessi, S Argon, L Li, P Chang, CD Le, P Zhao, L Zhang, Y Sugiyama, S-M Huang
- Journal Title
  
  CPT: Pharmacometrics & Systems Pharmacology
  
  Volume: 4 Issue: 8 Pages: 489-494
- DOI
  10.1002/psp4.55
- Peer Reviewed / Open Access / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K08089
[Journal Article] Causality assessment of possible adverse drug reactions in clinical trials: An analysis of factors associated with decision making by clinical investigators in Japan2015
- Author(s)
  Shinichiro Takeuchi, Makiko Kusama, Shunsuke Ono
- Journal Title
  
  Pharmaceutical Medicine
  
  Volume: 29 Issue: 5 Pages: 275-284
- DOI
  10.1007/s40290-015-0109-3
- Peer Reviewed / Acknowledgement Compliant
- Data Source
  KAKENHI-PROJECT-26460215
[Journal Article] Validity and reliability of the Japanese version of the newest vital sign: a preliminary study.2014
- Author(s)
  Kogure T, Sumitani M, Suka M, Ishikawa H, Odajima T, Igarashi A, Kusama M, Okamoto M, Sugimori H, Kawahara K.
- Journal Title
  
  PLoS One
  
  Volume: 9
- Data Source
  KAKENHI-PROJECT-23590814
[Journal Article] Validity and reliability of the Japanese version of the newest vital sign : a preliminary study2014
- Author(s)
  Kogure T, Sumitani M, Suka M, Ishikawa H, Odajima T, Igarashi A, Kusama M, Okamoto M, Sugimori H, Kawahara K
- Journal Title
  
  PLoS One
  
  Volume: 9(4)
- Data Source
  KAKENHI-PROJECT-23590814
[Journal Article] The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs2014
- Author(s)
  Satoshi Fukunaga, Makiko Kusama, Shunsuke Ono
- Journal Title
  
  SpringerPlus
  
  Volume: 3 Issue: 1 Pages: 740-740
- DOI
  10.1186/2193-1801-3-740
- Peer Reviewed / Open Access
- Data Source
  KAKENHI-PROJECT-26460215
[Journal Article] The 14-item health literacy scale for Japanese adults (HLS-14).2013
- Author(s)
  Suka M, Odajima T, Kasai M, Igarashi A, Ishikawa H, Kusama M, Nakayama T, Sumitani M, Sugimori H.
- Journal Title
  
  Environ Health Prev Med.
  
  Volume: 18 Issue: 5 Pages: 407-415
- DOI
  10.1007/s12199-013-0340-z
- NAID
  10031201235
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-23590814
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[Journal Article] The 14-item health literacy scale for Japanese adults (HLS-14)2013
- Author(s)
  Machi Suka, Takeshi Odajima, Masayuki Kasai, Ataru Igarashi, Hirono Ishikawa, Makiko Kusama, Takeo Nakayama, Masahiko Sumitani, Hiroki Sugimori
- Journal Title
  
  Environmental Health and Preventive Medicine
  
  Volume: 印刷中
- NAID
  10031201235
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-23590814
[Journal Article] The 14-item health literacy scale for Japanese adults (HLS-14)2013
- Author(s)
  Suka M, Odajima T, Kasai M, Igarashi A, Ishikawa H, Kusama M, Nakayama T, Sumitani M, Sugimori H
- Journal Title
  
  Environ Health Prev Med
  
  Volume: 18 Pages: 407-415
- NAID
  10031201235
- Data Source
  KAKENHI-PROJECT-23590814
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-20590100, KAKENHI-PROJECT-21790109, KAKENHI-PROJECT-24229002
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-20249008, KAKENHI-PROJECT-21790109
[Presentation] 特殊な患者集団に関する添付文書改訂と医薬品リスク管理計画書の比較(第2報)2017
- Author(s)
  幕田里奈、西岡明子、草間真紀子、赤沢学、門田佳子
- Organizer
  日本薬学会　第137年会
- Place of Presentation
  仙台
- Data Source
  KAKENHI-PROJECT-15K08089
[Presentation] 特殊な患者集団に関する添付文書改訂と医薬品リスク管理計画書の比較(第1報)2017
- Author(s)
  西岡明子、幕田里奈、草間真紀子、赤沢学、門田佳子
- Organizer
  日本薬学会　第137年会
- Place of Presentation
  仙台
- Data Source
  KAKENHI-PROJECT-15K08089
[Presentation] 医薬品のリスクベネフィット評価に対する多基準決定分析（MCDA）の利用可能性の検討2014
- Author(s)
  星川昂平, 草間真紀子, 小野俊介
- Organizer
  日本臨床薬理学会学術総会
- Place of Presentation
  ひめぎんホール（愛媛県松山市）
- Year and Date
  2014-12-04
- Data Source
  KAKENHI-PROJECT-26460215
[Presentation] グローバル開発環境下での日本の小児適応取得のラグと関係する要因の分析2014
- Author(s)
  神川典子, 草間真紀子, 小野俊介
- Organizer
  日本臨床薬理学会学術総会
- Place of Presentation
  ひめぎんホール（愛媛県松山市）
- Year and Date
  2014-12-04
- Data Source
  KAKENHI-PROJECT-26460215
[Presentation] 新薬の臨床開発経路とドラッグラグの関係の分析2014
- Author(s)
  延山尚幸, 草間真紀子, 小野俊介
- Organizer
  日本臨床薬理学会学術総会
- Place of Presentation
  ひめぎんホール（愛媛県松山市）
- Year and Date
  2014-12-06
- Data Source
  KAKENHI-PROJECT-26460215
[Presentation] 新薬の臨床評価と薬価算定方式における加算メカニズムの分析2014
- Author(s)
  柳澤真央, 草間真紀子, 小野俊介
- Organizer
  日本臨床薬理学会学術総会
- Place of Presentation
  ひめぎんホール（愛媛県松山市）
- Year and Date
  2014-12-06
- Data Source
  KAKENHI-PROJECT-26460215
[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
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Data Source
  KAKENHI-PROJECT-21790109
[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
- Data Source
  KAKENHI-PROJECT-21790109

1. ONO Shunsuke (40345591)

# of Collaborated Projects: 3 results

# of Collaborated Products: 18 results
2. SUGIMORI HIROKI (20276554)

# of Collaborated Projects: 1 results

# of Collaborated Products: 5 results
3. OKAMOTO Masako (00391201)

# of Collaborated Projects: 1 results

# of Collaborated Products: 2 results
4. IKARASHI Ataru (20508147)

# of Collaborated Projects: 1 results

# of Collaborated Products: 5 results
5. ISHIKAWA Hirono (40384846)

# of Collaborated Projects: 1 results

# of Collaborated Products: 5 results
6. SUKA Machi (30339858)

# of Collaborated Projects: 1 results

# of Collaborated Products: 0 results
7. SUMITANI Masao (80420420)

# of Collaborated Projects: 1 results

# of Collaborated Products: 5 results
8. Akemi Nitta (00737744)

# of Collaborated Projects: 1 results

# of Collaborated Products: 0 results
9. 前田和哉 (00345258)

# of Collaborated Projects: 1 results

# of Collaborated Products: 1 results
10. 赤沢学 (80565135)

# of Collaborated Projects: 1 results

# of Collaborated Products: 2 results
11. 門田佳子 (20568951)

# of Collaborated Projects: 1 results

# of Collaborated Products: 2 results
12. 森脇睦子 (40437570)

# of Collaborated Projects: 1 results

# of Collaborated Products: 0 results
13. 今井志乃ぶ (50608750)

# of Collaborated Projects: 1 results

# of Collaborated Products: 0 results
14. MAEDA Eri

# of Collaborated Projects: 1 results

# of Collaborated Products: 0 results
15. ODAJIMA Takeshi

# of Collaborated Projects: 1 results

# of Collaborated Products: 5 results
16. 須加万智

# of Collaborated Projects: 0 results

# of Collaborated Products: 5 results
17. 杉山雄一

# of Collaborated Projects: 0 results

# of Collaborated Products: 1 results

KUSAMA Makiko 草間 真紀子

Research Projects

Research Products

Co-Researchers

The pharmacoepidemiology of Potentially Inappropriae Medications among elderly: The analysis of Japanese clinical database.

Principal Investigator

Project Period (FY)

Research Category

Research Field

Research Institution

特殊な患者集団に対する添付文書の記載と情報に関する研究Principal Investigator

Principal Investigator

Project Period (FY)

Research Category

Research Field

Research Institution

Associations between global drug development strategies and the health outcomes in Japanese patients

Principal Investigator

Project Period (FY)

Research Category

Research Field

Research Institution

Study of developing Japanese version of health literacy scales and fertility knowledge scale in health care

Principal Investigator

Project Period (FY)

Research Category

Research Field

Research Institution

Exploring international differences in approved doses of drugsPrincipal Investigator

Principal Investigator

Project Period (FY)

Research Category

Research Field

Research Institution

[Journal Article] Organ Impairment-Drug-Drug Interaction Database: A Tool for Evaluating the Impact of Renal or Hepatic Impairment and Pharmacologic Inhibition on the Systemic Exposure of Drugs.2015

Author(s)

Journal Title

DOI

Data Source

[Journal Article] Causality assessment of possible adverse drug reactions in clinical trials: An analysis of factors associated with decision making by clinical investigators in Japan2015

Author(s)

Journal Title

DOI

Data Source

[Journal Article] Validity and reliability of the Japanese version of the newest vital sign: a preliminary study.2014

Author(s)

Journal Title

Data Source

[Journal Article] Validity and reliability of the Japanese version of the newest vital sign : a preliminary study2014

Author(s)

Journal Title

Data Source

[Journal Article] The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs2014

Author(s)

Journal Title

DOI

Data Source

[Journal Article] The 14-item health literacy scale for Japanese adults (HLS-14).2013

Author(s)

Journal Title

DOI

NAID

Data Source

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

Author(s)

Journal Title

DOI

Data Source

[Journal Article] The 14-item health literacy scale for Japanese adults (HLS-14)2013

Author(s)

Journal Title

NAID

Data Source

[Journal Article] The 14-item health literacy scale for Japanese adults (HLS-14)2013

Author(s)

Journal Title

NAID

Data Source

[Journal Article] Inclusion of human intravenous study data in new drug applications-impact of the Japanese guidance2012

Author(s)

KUSAMA Makiko 草間真紀子