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Using Extraordinary Optical Transmission to Quantify Cardiac Biomarkers in Human Serum
09:23

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Qualification of cardiac troponins for nonclinical use: a regulatory perspective

E A Hausner1, K A Hicks, J K Leighton

  • 1Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, United States.

Regulatory Toxicology and Pharmacology : RTP
|July 24, 2013
PubMed

Keywords:
AnalyticalBQRTBiomarker Qualification Review TeamBiomarkersCDERCLSICardiac troponinsCenter for Drug Evaluation and ResearchClinical and Laboratory Standards InstituteDDTDrug Development ToolDrug Development ToolsELISAFDAFood and Drug AdministrationH&EHESIHealth and Environmental Sciences InstituteHistopathologyILSIINDInternational Life Sciences InstituteInvestigational New DrugLODLOINDANOAELNew Drug ApplicationQualificationSafety assessmentenzyme-linked immunosorbent assayhematoxylin and eosinletter of intentlimit of detectionno observed adverse effect level

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