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 Kenneth J. Jr.; Buckley Donna C.; Malone Misti L.

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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

机译：通过对血管内装置进行全局临床试验设计来治疗临界肢体缺血的协调：美国食品和药物管理局的观点

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来源
《Circulation journal》 |2018年第12期|共2页
作者
Cavanaugh Kenneth J. Jr.; Buckley Donna C.; Malone Misti L.;
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作者单位

US FDA Div Cardiovasc Devices Off Device Evaluat 10903 New Hampshire Ave Silver Spring MD;

US FDA Div Cardiovasc Devices Off Device Evaluat 10903 New Hampshire Ave Silver Spring MD;

US FDA Div Cardiovasc Devices Off Device Evaluat 10903 New Hampshire Ave Silver Spring MD;

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原文格式 PDF
正文语种 eng
中图分类心脏、血管（循环系）疾病;
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1. 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 [J] . Cavanaugh Kenneth J. Jr., Buckley Donna C., Malone Misti L. Circulation journal . 2018,第12期

机译：通过对血管内装置进行全局临床试验设计来治疗临界肢体缺血的协调：美国食品和药物管理局的观点
2. Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI)　― A Joint USA-Japanese Perspective ― [J] . Hiroyoshi Yokoi, Mami Ho, Shin Iwamoto, Circulation journal . 2018,第9期

机译：危重肢体缺血（CLI）血管内器械全球临床试验的设计策略-美国-日本的共同观点-
3. Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) - A Joint USA-Japanese Perspective [J] . Yokoi Hiroyoshi, Ho Mami, Iwamoto Shin, Circulation journal . 2018,第9期

机译：关键肢体缺血（CLI）血管内装置全球临床试验的设计策略 - 一种联合美国 - 日本视角
4. Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving US Food and Drug Administration Premarket Approval in 2010 and 2011. [D] . Rathi, Vinay Kumar. 2016

机译：在2010年和2011年获得美国食品药品监督管理局上市前批准的高风险治疗性医疗器械整个产品生命周期中进行的临床研究。
5. Rationale and Design of a Prospective Multicenter Single-Arm Clinical Trial to Investigate the Safety and Effectiveness of Rotablator Atherectomy System as an Adjunctive Device for Endovascular Treatment of Occlusive Atherosclerotic Lesions in Below-the-Knee Arteries With Critical Limb Ischemia (RESCUE-BTK) [O] . Takeshi Yagyu, Shin Ito, Osami Kawarada, 2020

机译：探讨旋转器粥样切除术的安全性和有效性作为临床动脉患者止血动脉血管粥样硬化病变的辅血装置的安全性和有效性探讨了旋转器粥样切除术的安全性和有效性（Rescue-BTK ）
6. Rationale and Design of Randomized Clinical Trial for the Assessment of Macitentan Efficiency as Coadjuvant Treatment to Open and Endovascular Revascularization in Critical Limb Ischemia [O] . Ignacio Michel, Joaquin De Haro, Silvia Bleda, 2016

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7. FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff [R] . 2014

机译：FDa关于研究设备豁免的决定临床调查：赞助商指南，机构审查委员会和食品药品管理局工作人员

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

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