Methodology to Assess Clinical Liver Safety Data

Drug Safety

Volumn 37, Issue 1, 2014, Pages 33-45

  Merz, Michael ^a   Lee, Kwan R ^b   Kullak Ublick, Gerd A ^a,c   Brueckner, Andreas ^a   Watkins, Paul B ^d,e  

^a NOVARTIS PHARMA AG   (Switzerland)

^b GLAXOSMITHKLINE   (United States)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^d Hamner University of North Carolina Institute for Drug Safety Sciences   (United States)

^e The University of North Carolina at Chapel Hill   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASCORBIC ACID; BIOLOGICAL MARKER; CYANOCOBALAMIN; DOXYLAMINE; FLUTICASONE PROPIONATE; IBUPROFEN; SALBUTAMOL; VITAMIN D;

BLOOD CHEMISTRY; CLINICAL ASSESSMENT; CLINICAL TRIAL (TOPIC); COMPUTER GRAPHICS; CORRELATION ANALYSIS; DATA ANALYSIS; DOSE RESPONSE; DRUG SAFETY; HUMAN; INCIDENCE; KAPLAN MEIER METHOD; LABORATORY TEST; LIVER; LIVER FUNCTION; LIVER FUNCTION TEST; MULTIVARIATE ANALYSIS; OUTLIER DETECTION; PARAMETERS; PUBLISHING; REVIEW; RISK ASSESSMENT; STATISTICAL ANALYSIS; STATISTICS; TOXIC HEPATITIS; TRUNCATED ROBUST MULTIVARIATE OUTLIER DETECTION; WORKFLOW; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; METHODOLOGY; PROCEDURES; TIME FACTOR;

CLINICAL TRIALS AS TOPIC; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; RESEARCH DESIGN; RISK ASSESSMENT; TIME FACTORS;

EID: 84919881685     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0184-5     Document Type: Review

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