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
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
規制当局の論理構造に関する分析 To analyze regulatory bodies' theoretical framework
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
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
Osako R, Matsumaru N, Tsukamoto K. Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States. Ther Innov Regul Sci. 2025 Jan;59(1):142-149.
Hino Y, Okada M, Hallgreen CE, De Bruin ML, Doty RE, Matsumaru N, Tsukamoto K. Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan. Biol Pharm Bull. 2023 May 1;46(5):700-706.
Maeda H, Uchida M, Kusano M, Tsukamoto K, Yamanoi M. Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021. Clin Pharmacol Ther. 2022 Oct;112(4):817-823.
Sawachi K, Matsumaru N, Tsukamoto K. Clinical development of anticancer drugs can be enhanced using efficacy data of small population clinical trials. J Clin Pharm Ther. 2022 Sep;47(9):1388-1394.
Tajima G, Matsumaru N, Tsukamoto K. Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan. J Clin Pharm Ther. 2022 Sep;47(9):1395-1401.
