Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.

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作者： Elena S,Izmailova ^[1] ; William A,Wood ^[2] ; Qi,Liu ^[3] ; Vadim,Zipunnikov ^[4] ; Daniel,Bloomfield ^[5] ; Jason,Homsy ^[6] ; Steven C,Hoffmann ^[7] ; John A,Wagner ^[8] ; Joseph P,Menetski ^[7]

作者单位： Koneksa Health, New York, New York, USA. ^[1] Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA. ^[2] Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA. ^[3] Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. ^[4] Anthos Therapeutics, Cambridge, Massachusetts, USA. ^[5] Takeda Pharmaceuticals International, Cambridge, Massachusetts, USA. ^[6] Foundation for the National Institutes of Health (NIH), North Bethesda, Maryland, USA. ^[7] Cygnal Therapeutics, Cambridge, Massachusetts, USA. ^[8]

关键词 Biomarkers Cardiac Digital health Evidentiary criteria Remote monitoring Sensors

DOI 10.1159/000515110

PMID 34056520

发布时间 2021-06-01

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Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.

Digital biomarkers

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Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.

Digital biomarkers

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Digital biomarkers

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