Qualification of cardiac troponins for nonclinical use: A regulatory perspective

Regulatory Toxicology and Pharmacology

Volumn 67, Issue 1, 2013, Pages 108-114

  Hausner, E A ^a   Hicks, K A ^a   Leighton, J K ^a   Szarfman, A ^a   Thompson, A M ^a   Harlow, P ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Analytical; Biomarkers; Cardiac troponins; Drug Development Tools; Histopathology; Qualification; Safety assessment

Indexed keywords

TROPONIN;

ANIMAL TISSUE; ARTICLE; BIOASSAY; CARDIOTOXICITY; CONTROLLED STUDY; DATA ANALYSIS; DATA MINING; DISEASE MARKER; EVALUATION RESEARCH; EXPERIMENTAL ANIMAL; HEART INJURY; HISTOPATHOLOGY; LIMIT OF DETECTION; NONHUMAN; PRIORITY JOURNAL; PROTEIN ANALYSIS; TOXICOLOGY; TRANSLATIONAL RESEARCH; VALIDATION PROCESS;

ANALYTICAL; BIOMARKER QUALIFICATION REVIEW TEAM; BIOMARKERS; BQRT; CARDIAC TROPONINS; CDER; CENTER FOR DRUG EVALUATION AND RESEARCH; CLINICAL AND LABORATORY STANDARDS INSTITUTE; CLSI; DDT; DRUG DEVELOPMENT TOOL; DRUG DEVELOPMENT TOOLS; ELISA; ENZYME-LINKED IMMUNOSORBENT ASSAY; FDA; FOOD AND DRUG ADMINISTRATION; H&E; HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE; HEMATOXYLIN AND EOSIN; HESI; HISTOPATHOLOGY; ILSI; IND; INTERNATIONAL LIFE SCIENCES INSTITUTE; INVESTIGATIONAL NEW DRUG; LETTER OF INTENT; LIMIT OF DETECTION; LOD; LOI; NDA; NEW DRUG APPLICATION; NO OBSERVED ADVERSE EFFECT LEVEL; NOAEL; QUALIFICATION; SAFETY ASSESSMENT;

ANIMALS; BIOLOGICAL MARKERS; DRUG APPROVAL; HUMANS; MYOCARDIUM; TROPONIN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84883451317     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.07.006     Document Type: Article

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