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Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.
Izmailova, Elena S; Wood, William A; Liu, Qi; Zipunnikov, Vadim; Bloomfield, Daniel; Homsy, Jason; Hoffmann, Steven C; Wagner, John A; Menetski, Joseph P.
Afiliación
  • Izmailova ES; Koneksa Health, New York, New York, USA.
  • Wood WA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Liu Q; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zipunnikov V; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Bloomfield D; Anthos Therapeutics, Cambridge, Massachusetts, USA.
  • Homsy J; Takeda Pharmaceuticals International, Cambridge, Massachusetts, USA.
  • Hoffmann SC; Foundation for the National Institutes of Health (NIH), North Bethesda, Maryland, USA.
  • Wagner JA; Cygnal Therapeutics, Cambridge, Massachusetts, USA.
  • Menetski JP; Foundation for the National Institutes of Health (NIH), North Bethesda, Maryland, USA.
Digit Biomark ; 5(1): 103-113, 2021.
Article en En | MEDLINE | ID: mdl-34056520

Texto completo: 1 Bases de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Digit Biomark Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Bases de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Digit Biomark Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos