C/E-25（共同研究）

Satake M, Ito S, Sawano C, Scuffham P, Tsukamoto K. Benefit-risk assessment of HPV vaccination programs in Australia, the United States, and Japan. Vaccine. 2026; 78: 11 April 2026, 128407. doi: https://doi.org/10.1016/j.vaccine.2026.128407

C/E-24（共同研究）

Shingyo N, Taguchi M, Matsubara M, Shichijyo M, Matsumaru N, Tsukamoto K. Role of Companion Diagnostics in Advancing Patient-Centered Anticancer Drug Treatment. Biol Pharm Bull. 2025; 48(8): 1255-1259. doi: https://doi.org/10.1248/bpb.b25-00240.

E-13

Taguchi A, Matsumaru N, Tsukamoto K. Approval of high-benefit oncology drugs in Japan: utilization of expedited regulatory pathways for the accelerated approved anticancer drugs. Invest. New Drugs. 2025. doi: 10.1007/s10637-025-01549-0. Online ahead of print. PMID: 40465174

E-12

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. doi: 10.1007/s43441-024-00714-6. PMID: 39441417

C/E-23（共同研究）

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. doi: 10.1248/bpb.b22-00868. Epub 2023 Mar 4. PMID: 36878610.

C/E-22（共同研究）

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. doi: 10.1002/cpt.2641. Epub 2022 Jun 7. PMID: 35569010; PMCID: PMC9540178.​

E-11

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. doi: 10.1111/jcpt.13676. Epub 2022 May 7. PMID: 35524471.

E-10

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. doi: 10.1111/jcpt.13677. Epub 2022 Apr 30. PMID: 35488803.​

C/E-21（共同研究）

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. doi: 10.1248/bpb.b21-00898. PMID: 35370272.​

E-9

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. Pharmaceut Med. 2021 Jul;35(4):253-260. doi: 10.1007/s40290-021-00393-w. Epub 2021 Jul 22. PMID: 34291425.

E-8

​Izuka S, Matsumaru N, Tsukamoto K. Characteristics of drugs approved in Japan without conducting confirmatory clinical trials. J Clin Pharm Ther. 2021 Dec;46(6):1582-1590. doi: 10.1111/jcpt.13487. Epub 2021 Jul 11. PMID: 34250620.

C/E-20（共同研究）

​Ohno S, Chen Y, Sakamaki H, Matsumaru N, Yoshino M, Tsukamoto K. Burden of caring for Alzheimer's disease or dementia patients in Japan, the US, and EU: results from the National Health and Wellness Survey: a cross-sectional survey. J Med Econ. 2021 Jan-Dec;24(1):266-278. doi: 10.1080/13696998.2021.1880801. PMID: 33538195.

C/E-19（共同研究）

Ohno S, Chen Y, Sakamaki H, Matsumaru N, Yoshino M, Tsukamoto K. Humanistic burden among caregivers of patients with Alzheimer's disease or dementia in Japan: a large-scale cross-sectional survey. J Med Econ. 2021 Jan-Dec;24(1):181-192. doi: 10.1080/13696998.2021.1877149. PMID: 33467967.

C/E-18（共同研究）

​Ohno S, Chen Y, Sakamaki H, Matsumaru N, Tsukamoto K. Factors associated with humanistic burden and indirect cost among patients with cancer in Japan. J Med Econ. 2020 Dec;23(12):1570-1578. doi: 10.1080/13696998.2020.1839234. Epub 2020 Nov 5. PMID: 33074747.

C/E-17（共同研究）

​Shibata S, Matsushita M, Tsukamoto K, Chiba K, Ozaki K, Suzuki T, A Study on the Description of Anticancer Drug Combination Therapy in the Package Insert in Japan, BPB Reports, 2020, Volume 3, Issue 5, Pages 157-165, Released on J-STAGE November 26, 2020, Online ISSN 2434-432X, https://doi.org/10.1248/bpbreports.3.5_157, https://www.jstage.jst.go.jp/article/bpbreports/3/5/3_157/_article/-char/en

C/E-16（共同研究）

Ohno S, Shoji A, Hatake K, Oya N, Igarashi A. Cost-effectiveness analysis of treatment regimens with obinutuzumab plus chemotherapy in Japan for untreated follicular lymphoma patients. J Med Econ. 2020 Oct;23(10):1130-1141. doi: 10.1080/13696998.2020.1791890. Epub 2020 Jul 23. PMID: 32620061.

C/E-15（共同研究）

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 Regul Sci. 2021 Jan;55(1):48-55. doi: 10.1007/s43441-020-00189-1. Epub 2020 Jun 22. PMID: 32572770.

C/E-14（共同研究）

​Matsumaru N, Okada H, Suzuki K, Nachi S, Yoshida T, Tsukamoto K, Ogura S. Weather Fluctuations May Have an Impact on Stroke Occurrence in a Society: A Population-Based Cohort Study. Cerebrovasc Dis Extra. 2020;10(1):1-10. doi: 10.1159/000505122. Epub 2020 Feb 5. PMID: 32023618; PMCID: PMC7036586.

C/E-13（共同研究）

​Ohno S, Chen Y, Sakamaki H, Matsumaru N, Tsukamoto K. A population-based study of the humanistic burden among cancer patients in Japan. J Med Econ. 2020 May;23(5):429-441. doi: 10.1080/13696998.2019.1707213. Epub 2019 Dec 31. PMID: 31856614.

E-7

​Kido K, Tsukamoto K. Japan's health care system faces a perfect storm. Int J Health Plann Manage. 2020 Jan;35(1):e210-e217. German. doi: 10.1002/hpm.2936. Epub 2019 Nov 11. PMID: 31710130.

C/E-12（共同研究）

Kikuchi M, Adachi N, Matsumaru N, Tsukamoto K. Current Landscape of Late-Phase Clinical Trials for Alzheimer's Disease: Comparing Regional Variation Between Subjects in Japan and North America. Pharmaceut Med. 2019 Dec;33(6):511-518. doi: 10.1007/s40290-019-00306-y. PMID: 31933241.

C/E-11（共同研究）

​Ohno S, Chen Y, Sakamaki H, Matsumaru N, Tsukamoto K. Humanistic and economic burden among caregivers of patients with cancer in Japan. J Med Econ. 2020 Jan;23(1):17-27. doi: 10.1080/13696998.2019.1675672. Epub 2019 Oct 15. PMID: 31578893.

C/E-10（共同研究）

Shibata Y, Miyahara Y, Sadaka Y, Yasue M, Fujimura M, Soda M, Yamamoto M, Kato H, Suzuki A, Tsukamoto K, Hara T, Tsurumi H, Kitaichi K. Evaluation of the effectiveness of caspofungin against febrile neutropenia and the factors related to the alteration in its plasma concentration. J Infect Chemother. 2019 Oct;25(10):801-805. doi: 10.1016/j.jiac.2019.04.011. Epub 2019 Apr 29. PMID: 31047782.

C/E-9（共同研究）

​Nakayama H, Matsumaru N, Tsukamoto K. Safety-Related Regulatory Actions and Risk Factors for Anticancer Drugs in Japan. Pharmaceut Med. 2019 Feb;33(1):45-52. doi: 10.1007/s40290-018-0260-8. PMID: 31933266.

C/E-8（共同研究）

Nakayama H, Matsumaru N, Tsukamoto K. Delays in New Drug Applications and Associated Factors for Orphan Anticancer Drugs in Japan Compared with the USA. Pharmaceut Med. 2018 Nov;32, 403-412.

C/E-7（共同研究）

Tsukamoto K, Cnop M, Mori D, Kume S, Anazawa T, Doi M, Chikazawa K, Matsumaru N. Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework. Ther Innov Regul Sci. 2019 Jul;53(4):535-541. doi: 10.1177/2168479018795854. Epub 2018 Sep 3. PMID: 30176740.

E-6

Kido K, Matsumaru N, Tsukamoto K. Health Technology Assessment in Japan: A Pharmaceutical Industry Perspective. Ther Innov Regul Sci. 2019 Jul;53(4):472-480. doi: 10.1177/2168479018791136. Epub 2018 Aug 29. PMID: 30157674.

C/E-6（共同研究）

Nakayama H, Matsumaru N, Tsukamoto K. The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States. Invest New Drugs. 2019 Oct;37(5):1086-1093. doi: 10.1007/s10637-018-0612-y. Epub 2018 May 31. PMID: 29855823.

E-5

Tanaka M, Matsumaru N, Tsukamoto K. Influence of Breakthrough Therapy Designation in the United States on Oncology Drug Development Timelines in Japan. Pharm Med. 2018 June;32:201-207. doi.org/10.1007/s40290-018-0236-8

C/E-5（共同研究）

​Nakayama H, Tsukamoto K. Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan. Invest New Drugs. 2018 Aug;36(4):702-708. doi: 10.1007/s10637-018-0603-z. Epub 2018 Apr 17. PMID: 29667133.

E-4

Tanaka M, Matsumaru N, Tsukamoto K. Influence of Expedited Programs in the United States on Oncology Drug Development in Japan. Ther Innov Regul Sci. 2019 Mar;53(2):199-206. doi: 10.1177/2168479018769288. Epub 2018 May 6. PMID: 29732928.

E-3

Rokuda M, Matsumaru N, Tsukamoto K. Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan. Clin Ther. 2018 Feb;40(2):284-295. doi: 10.1016/j.clinthera.2017.12.010. Epub 2018 Feb 1. PMID: 29361305.

C/E-4（共同研究）

​Matsumaru N, Hattori R, Ichinomiya T, Tsukamoto K, Kato Z. New quantitative method for evaluation of motor functions applicable to spinal muscular atrophy. Brain Dev. 2018 Mar;40(3):172-180. doi: 10.1016/j.braindev.2017.12.003. PMID: 29395660.

C/E-3（共同研究）

​Soda M, Ito S, Matsumaru N, Nakamura S, Nagase I, Takahashi H, Ohno Y, Yasuda M, Yamamoto M, Tsukamoto K, Itoh Y, Deguchi T, Kitaichi K. Evaluation of the Microbiological Efficacy of a Single 2-Gram Dose of Extended-Release Azithromycin by Population Pharmacokinetics and Simulation in Japanese Patients with Gonococcal Urethritis. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e01409-17. doi: 10.1128/AAC.01409-17. PMID: 29038284; PMCID: PMC5740364.

E-2

​Onishi T, Tsukamoto K, Matsumaru N, Waki T. Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries. Ther Innov Regul Sci. 2018 Jan;52(1):49-56. doi: 10.1177/2168479017716718. Epub 2017 Jun 30. PMID: 29714619.

C/E-2（共同研究）

Tsukamoto K, Carroll KA, Onishi T, Matsumaru N, Brasseur D, Nakamura H. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks. Clin Ther. 2016 Mar;38(3):574-81. doi: 10.1016/j.clinthera.2016.01.012. Epub 2016 Feb 8. PMID: 26869192.

C/E-1（共同研究）

　Soda M, Shibata Y, Yasue M, Fujimura M, Takahashi H, Nakamura S, Yamamoto M, Tsukamoto K, Suzuki A, Hara T, Tsurumi H, Itoh Y, Kitaichi K.
　Simple HPLC method for the determination of caspofungin in human plasma

　Clin Pharmacol Biopharm. 4:137 (2015)

E-1

​Tsukamoto K. Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Regulatory Initiatives in Japan and the United States. Clin Ther. 2015 Aug;37(8):1652-60. doi: 10.1016/j.clinthera.2015.02.024. Epub 2015 Mar 21. PMID: 25801940.

J-6

塚本 桂, 井上 愛美, 森 浩仁, 松丸 直樹, HPVワクチンの一元的なベネフィット・リスク評価の確立, YAKUGAKU ZASSHI, 2022, 142 巻, 12 号, p. 1399-1407​

J-5

塚本 桂, 医薬品開発を見据えた薬理学とレギュラトリーサイエンス, 日本薬理学雑誌, 2016, 148 巻, 1 号, p. 4-8

J-4

塚本 桂, 松丸 直樹, レギュラトリーサイエンス教育と研究への取り組みに関する欧米の現況, レギュラトリーサイエンス学会誌, 2016, 6 巻, 2 号, p. 163-169

J-3

塚本 桂, 竹中 登一, グローバル医薬品開発におけるレギュラトリーサイエンス：アカデミアの役割, YAKUGAKU ZASSHI, 2016, 136 巻, 4 号, p. 543-547

J-2

​塚本 桂, 実学としてのレギュラトリーサイエンス, ファルマシア, 2015, 51 巻, 7 号, p. 666-668

J-1

塚本 桂, 竹中 登一, アメリカにおけるレギュラトリーサイエンスの教育と研究の現状調査報告, レギュラトリーサイエンス学会誌, 2015, 5 巻, 1 号, p. 103-110