Field of Study
regulatory science, data science
drug development, regulation, benefit-risk analysis
  • 教授 塚本 桂 Professor Tsukamoto Katsura Ph.D. tsukamoto
  • 准教授 松丸 直樹 Associate Professor Matsumaru Naoki Ph.D. matsumaru
  • 客員教授 竹中 登一 Visiting Professor Takenaka Toichi Ph.D.

研究テーマ Research Subjects

 医薬品の開発と使用には、様々な段階で様々な立場の Go / No Go 判断が必要です。その判断の根拠となるのが、レギュラトリーサイエンスであり、立場の違いを包括して社会にとって望ましい判断に調整する役割を担っています。最適な時点における正確で適切な判断は、医薬品開発の効率化とともに有効かつ安全な医薬品の創造に必須であり、科学に基づく判断基準の設定が重要となります。当研究室では、世界の実例、過去の事例を分析し、判断基準を設定する理論構造を理解し、変化を予測・提言していきます。「より良い医薬品・医療機器を全ての患者さんに届けたい」の願い実現するために、レギュラトリーサイエンスの研究と教育をグローバルに展開し、医薬品開発の効率化、患者や社会にとってより良い医療の提供を担う、より優れた開発戦略の提案と人材の育成を目指しています。

 Go/No Go decision makings by various perspectives at various steps are required for drug development and use. Regulatory Science supports the decision makings and plays an important role for regulating to conclude the desirable decision for society beyond various standpoints. Accurate and proper judgement in suitable timing is the essential for efficient drug development as well as creation of effective and safe drugs. The establishment of criterion based on science is important for the judgement. The Global Regulatory Science (GRS) aims to study the regulatory science through analyzing cases and transitions of criteria in the world and to create the evaluation criteria for drug development and approval. We are trying to understand theoretical structure for the judgement, and to predict and propose future change. Our final goal through research and education is to provide better pharmaceuticals and medical devices to every patient. We are expanding the research and education of regulatory science to global based on pharmaceutics background, and aiming to produce innovative medicines and foster human resources.


研究課題 Research Objectives

  1. 規制当局の医薬品製造販売許認可の判断に関する分析
    To analyze regulatory bodies' decision for the authorization of drugs and medical devices
  2. 規制当局の論理構造に関する分析
    To analyze regulatory bodies' theoretical framework
  3. 製薬企業における臨床開発や薬事戦略の分析
    To analyze pharmaceutical companies' clinical development and pharmaceutical affairs strategies
  4. 規制当局内部門間の判断基準比較研究
    To investigate the comparative evaluation criteria between divisions in regulatory bodies

シーズ Research Topics

最近の研究成果 Research Results

  1. Miyazaki T, Komiyama M, Matsumaru N, Maeda H, Tsukamoto K. Lag Time for New Innovative, First-in-Class, Drug Approval in Japan. Biol Pharm Bull. 2022; 45(4):477-482.

  2. Ushijima S, Matsumaru N, Tsukamoto K. Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi‑regional Clinical Trials. Pharm Med. 2021;35:253-260.

  3. Izuka S, Matsumaru N, Tsukamoto K. Characteristics of drugs approved in Japan without conducting confirmatory clinical trials. J Clin Pharm Ther. 2021;46:1582-1590.

  4. Ohno S, Chen Y, Sakamaki H, Matsumaru N, Yoshino M, Tsukamoto K. Burden of caring for Alzheimer's disease or dementia patients in Japan, US, and EU: results from the National Health and Wellness Survey: a cross-sectional survey. J Med Econ. 24(1):266-278 (2021).

  5. Matsumoto T, Matsumaru N, Scuffham P, Neels P, Tsukamoto K. Alternative New Mono‑scaled Quantitative Benefit-Risk Assessment of Human Papillomavirus Vaccine in Japan. Ther Innov Reg Sci. 55(1):48-55 (2021).