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Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan

Circulation journal : official journal of the Japanese Circulation Society, 2024-09, Article CJ-24-0474

2024

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Long-term efficacy and safety of romiplostim in refractory aplastic anemia: follow-up of a phase 2/3 study

Blood advances, 2024-03, Vol.8 (6), p.1415-1419

2024

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Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct

Cardiovascular revascularization medicine, 2023-07, Vol.52, p.67-74

2023

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Cyberbullying and Internet Usage by Tool and Purpose among College Students

The Proceedings of the Annual Convention of the Japanese Psychological Association, 2023, Vol.87, p.3-3C-016-PD

2023

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Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Circulation Journal, 2022/11/25, Vol.86(12), pp.1990-1997

2022

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Efficacy and Safety of Long-Term Romiplostim Use for Refractory Aplastic Anemia

Blood, 2022-11, Vol.140 (Supplement 1), p.8634-8637

2022

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Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Circulation Journal, 2022/09/01, pp.CJ-22-0185

2022

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Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective

Cardiovascular revascularization medicine, 2022-04, Vol.37, p.118-119

2022

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Kamikihito rescued depressive-like behaviors and hippocampus neurogenesis in chronic restraint stress rats

Journal of Traditional and Complementary Medicine, 2022-03, Vol.12 (2), p.172-179

2022

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Comparison Between PID and Predictive Controllers Applied to a Cooling System

Water-Energy-Nexus in the Ecological Transition, p.475-478

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Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan

Journal of wound care, 2021-08, Vol.30 (8), p.666-676

2021

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Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Circulation Reports, 2021/03/10, Vol.3(3), pp.153-160

2021

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Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Journal of artificial organs, 2021-03, Vol.24 (1), p.90-101

2021

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Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint

Heart and vessels, 2021-02, Vol.36 (2), p.155-162

2021

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Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Circulation Reports, 2021/01/26, pp.CR-20-0136

2021

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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Internal Medicine, 2021/01/15, Vol.60(2), pp.161-166

2021

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Multiple genotypes of enterovirus G carrying a papain-like cysteine protease (PL-CP) sequence circulating on two pig farms in Japan: first identification of enterovirus G10 carrying a PL-CP sequence

Archives of virology, 2020-12, Vol.165 (12), p.2909-2914

2020

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Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Circulation Journal, 2020/08/25, Vol.84(9), pp.1568-1574

2020

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Diversity Types in a Top Management Team and the Process of Strategic Change

Academy of Management Annual Meeting Proceedings, 2020, Vol.2020 (1), p.12431

2020

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Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Circulation Journal, 2020/07/17, pp.CJ-20-0133

2020

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Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children

Circulation Journal, 2020/04/24, Vol.84(5), pp.786-791

2020

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Patient and lesion characteristics in late/very late stent thrombosis with everolimus-eluting stents from real-world adverse event reporting

Journal of cardiology, 2020-03, Vol.75 (3), p.255-260

2020

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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Internal Medicine, 2020, pp.4286-19

2020

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Oral kyuki-kyogai-to (KKT) for intestinal bleeding in Fontan-associated protein-losing enteropathy

Pediatrics international, 2019-09, Vol.61 (9), p.935-937

2019

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Regulatory approval review of transcatheter mitral valve repair – Difference in the indication between the USA and Japan

Journal of cardiology, 2019-07, Vol.74 (1), p.13-18

2019

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Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan

Long-term efficacy and safety of romiplostim in refractory aplastic anemia: follow-up of a phase 2/3 study

Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct

Cyberbullying and Internet Usage by Tool and Purpose among College Students

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Efficacy and Safety of Long-Term Romiplostim Use for Refractory Aplastic Anemia

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective

Kamikihito rescued depressive-like behaviors and hippocampus neurogenesis in chronic restraint stress rats

Comparison Between PID and Predictive Controllers Applied to a Cooling System

Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan

Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint

Pediatric Medical Devices　― Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Multiple genotypes of enterovirus G carrying a papain-like cysteine protease (PL-CP) sequence circulating on two pig farms in Japan: first identification of enterovirus G10 carrying a PL-CP sequence

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Diversity Types in a Top Management Team and the Process of Strategic Change

Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children

Patient and lesion characteristics in late/very late stent thrombosis with everolimus-eluting stents from real-world adverse event reporting

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold

Oral kyuki-kyogai-to (KKT) for intestinal bleeding in Fontan-associated protein-losing enteropathy

Regulatory approval review of transcatheter mitral valve repair – Difference in the indication between the USA and Japan

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