第一作者:
E A,Hausner
第一单位:
Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, United States. Electronic address: Elizabeth.hausner@fda.hhs.gov.
作者:
关键词
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
医学主题词
动物(Animals);药物批准(Drug Approval);人类(Humans);心肌(Myocardium);肌钙蛋白(Troponin);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)
DOI
10.1016/j.yrtph.2013.07.006
PMID
23876748
发布时间
2015-11-19
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