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HBDの成果に関する公表論文・文献等

公表論文・文献等 著者名、公表雑誌名等 公表日
Harmonization by Doing : A Systems Approach to Conducting Responsible Reserch (Clinical Development of Antithrombotic Agents in Japan, The 69th Annual Scientific Meeting of the Japanese Circulation Society) Sase K. Circ J 69(Supplemnt_I), 79 2005-03-01
Harmonization by Doing (HBD) : Global Harmonization of Clinical Investigation and Research Infrastructure in Japan(Morning Lecture 2 (ML2) (H),The 70th Anniversary Annual Scientific Meeting of the Japanese Circulation Society) Sase K. Circ j, 70(Supplement_I), 96 2006-03-01
FDA PERSPECTIVES ON GLOBAL TRIAL DEVELOPMENT FOR MECHANICAL CIRCULATORY SUPPORT DEVICES: INTERMACS AND HARMONIZATION BY DOING PROGRAMS Chen E. Journal of the Japanese Society for Artificial Organs and Tissues. 36(2Supplement), s1-s1 2007
Comparing GCP Requirements for Medical Device Clinical Trials in the US and Japan Harmonization-by-Doing Working Group 4. RAPS Journal April 2010 2010
Current Trend of Reviewing and Regulation for Medical Devices : Complementary Approach with Global Regulatory Harmonization by GHTF and Practical International Clinical Trial by HBD [in Japanese] Sase K. Jpn. J. Clin. Pharmacol. Ther. 41(4), 133-139 2010-07-31
Harmonization by Data (HBD): Initial Experience with a Post-Marketing follow-up Study of Mechanical Circulatory Assist Devices (J-MACS), and Ongoing Collaborations with Academic Research Consortiums. [in Japanese] Sase K. Pharmaceutical and Medical Device Regulatory Science, 43(4), 339-346 2012
The First-ever Report on Multi-Company Survey of the Cost of Medical Device Clinical Trials in Japan : Results of a Collaborative Study [in Japanese] Kouzaki Y, Fukuzawa I, Akabori M, et al. Pharmaceutical and Medical Device Regulatory Science, 43(5), 452-463 2012
GCP Convergence Improves Transportability of Medical Device Clinical Data Harmonization-by-Doing Working Group 4. RAPS Regulatory Focus January 2013 2013
Summary Technical Documentation (STED):Harmonizing a Predictable Regulatory Submission Harmonization-by-Doing Working Group 4. RAPS Regulatory Focus September 2013 2013
Global Cardiovascular Device Innovation : Japan-USA Synergies : Harmonization by Doing (HBD) Program, a Consortium of Regulatory Agencies, Medical Device Industry, and Academic Institutions Uchida T, Ikeno F, Ikeda K et al. Circ J, Volume 77 (2013) Issue 7 Pages 1714-1718 2013
Rationale and design of the Japan-USA harmonized assessment by randomized, multicenter study of OrbusNEich's combo StEnt (Japan-USA HARMONEE): Assessment of a novel DES platform for percutaneous coronary revascularization in patients with ischemic coronary disease and non–ST-elevation acute coronary syndrome David F. Kong, MD, Shigeru Saito, MD, Shigeru Nakamura, MD, Roxana Mehran, MD, Stephen M. Rowland, PhD, Allison Handler, MHSc, Hussein R. Al-Khalidi, PhD, and Mitchell W. Krucoff, MD: Am Heart J 2017;187:112-121 2017
Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents Murakami M, Suzuki Y, Tominaga T. - Circ J. 2018 Feb 23;82(3):636-643 2018
Japanese registry for Mechanically Assisted Circulatory Support: First report. Nakatani T, Sase K, Oshiyama H, et al. The Journal of Heart and Lung Transplantation. Volume 36, Issue 10, October 2017, Pages 1087-1096 2017
Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) Hiroyoshi Yokoi, Mami Ho, Shin Iwamoto, Yuka Suzuki, Gary M. Ansel, Nobuyoshi Azuma, Nobuhiro Handa, Osamu Iida, Koji Ikeda, Fumiaki Ikeno, Norihiko Ohura, Kenneth Rosenfield, John Rundback, Hiroto Terashi, Takahiro Uchida, Yoshiaki Yokoi, Masato Nakamura, Michael R. Jaff: - A Joint USA-Japanese Perspective -. Circ J 2018; 82: 2233 – 2239 2018
Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective Cavanaugh K, Buckley D, Malone M. Circ J October 2018 2018
 

「医療機器の対面助言及び承認審査に係る米国FDAとの情報交換」に関連する論文

公表論文・文献等 著者名、公表雑誌名等 公表日
Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease : Twelve-Month Zilver PTX Randomized Study Results Michael D. Dake, Gary M. Ansel, Michael R. Jaff, Takao Ohki, Richard R. Saxon, H. Bob, Smouse, Thomas Zeller, Gary S. Roubin, Mark W. Burket, Yazan Khatib, Scott A. Snyder, Anthony O. Ragheb, J. King White and Lindsay S. Machan: Circ Cardiovasc Interv 2011;4;495-504 2011
Two-Year Analysis of the Japanese Cohort From the Zilver PTX Randomized Controlled Trial Supports the Validity of Multinational Clinical Trials Takao Ohki, Hiroyoshi Yokoi, Kimihiko Kichikawa, Takeshi Kimura, Scott A. Snyder, Anthony O. Ragheb, Erin E. O’Leary, Michael R. Jaff, Gary M. Ansel, and Michael D. Dake: J ENDOVASC THER 2014;21:644–653 2014
Collaborative Review Scheme with US FDA and Harmonization By Doing (HBD) Activities Towards Speedier Review of Medical Devices Iwamoto S, Ho M, Suzuki Y. RSMP, Volume 5 (2015) Issue 3 Pages 227-234 2015
Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery 5-Year Results of the Zilver PTX Randomized Trial Michael D. Dake, MD; Gary M. Ansel, MD; Michael R. Jaff, DO; Takao Ohki, MD; Richard R. Saxon, MD; H. Bob Smouse, MD; Lindsay S. Machan, MD; Scott A. Snyder, PhD; Erin E. O’Leary, PhD; Anthony O. Ragheb, PhD; Thomas Zeller, MD; on behalf of the Zilver PTX Investigators: Circulation. 2016;133:1472-1483 2016
One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study) Takao Ohki, MD, John F. Angle, MD, Hiroyoshi Yokoi, MD, Michael R. Jaff, DO, Jeffrey Popma, MD, Guy Piegari, MD, and Yuji Kanaoka, MD, for the OSPREY investigators, J Vasc Surg. 2016;63:370-376 2016

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