FDA Approval of Andexanet Alfa Based on a Single-Arm Trial: If There Is a Villain, Who Is It? reply

Radecki Ryan P.; Spiegel Rory J.; Wang Henry E.

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FDA Approval of Andexanet Alfa Based on a Single-Arm Trial: If There Is a Villain, Who Is It? reply

机译：FDA基于单臂试验的Andexanet Alfa批准：如果有一个恶棍，那是谁？回复

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《Annals of Emergency Medicine: Journal of the American College of Emergency Physicians and the University Association for Emergency Medicine》 |2019年第5期|共1页
作者
Radecki Ryan P.; Spiegel Rory J.; Wang Henry E.;
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作者单位

Northwest Permanente Portland OR 97232 USA;

Univ Maryland Baltimore MD 21201 USA;

Univ Texas Hlth Sci Ctr Houston Houston TX 77030 USA;

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原文格式 PDF
正文语种 eng
中图分类内科学;
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1. FDA Approval of Andexanet Alfa Based on a Single-Arm Trial: If There Is a Villain, Who Is It? reply [J] . Radecki Ryan P., Spiegel Rory J., Wang Henry E. Annals of Emergency Medicine: Journal of the American College of Emergency Physicians and the University Association for Emergency Medicine . 2019,第5期

机译：FDA基于单臂试验的Andexanet Alfa批准：如果有一个恶棍，那是谁？回复
2. RE: Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-Analysis of Clinical Trials Leading to FDA Approval [J] . Freidlin Boris, Korn Edward L. Journal of the National Cancer Institute . 2016,第3期

机译：RE：基于生物标志物的策略对肿瘤药物开发的影响：一项获得FDA批准的临床试验的荟萃分析
3. Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-Analysis of Clinical Trials Leading to FDA Approval (vol 107, djv253, 2015) [J] . Jardim Denis L. Fontes, Schwaederle Maria, Wei Caimiao, Journal of the National Cancer Institute . 2016,第2期

机译：基于生物标志物的策略对肿瘤药物开发的影响：一项获得FDA批准的临床试验的荟萃分析（vol 107，djv253，2015）
4. The travail involved in getting FDA approval . . . an overview on what it took to get FDA approval of a medical device with computer technology (A recent experience) [C] . Paul, A. Engineering of Computer-Based Medical Systems, 1988., Proceedings of the Symposium on the . 1988

机译：这次灾难涉及获得FDA批准。。。 FDA批准使用计算机技术的医疗设备所需的概述（最近的经验）
5. Male Circumcision as a Bio-medical HIV Intervention Targeting Male Heterosexual Sexually Transmitted Disease (STD) Patients in China - An Acceptability Study and a Single-arm Test-of-concept Trial. [D] . Wang, Zixin. 2013

机译：男性包皮环切术作为针对中国男性异性恋性传播疾病（STD）患者的生物医学HIV干预-可接受性研究和单臂概念测试试验。
6. RE: Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-Analysis of Clinical Trials Leading to FDA Approval [O] . Boris Freidlin, Edward L. Korn -1

机译：RE：基于生物标志物的策略对肿瘤药物开发的影响：一项获得FDA批准的临床试验的荟萃分析
7. FDA Approval of Andexanet Alfa Based on a Single-Arm Trial: If There Is a Villain, Who Is It? [O] . Daniel J. Pallin 2019

机译：FDA基于单臂试验的Andexanet Alfa批准：如果有一个恶棍，那是谁？

FDA Approval of Andexanet Alfa Based on a Single-Arm Trial: If There Is a Villain, Who Is It? reply

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