Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials

Drug Safety

Volumn 37, Issue 1, 2014, Pages 19-31

  Avigan, Mark I ^a   Bjornsson, Einar S ^b   Pasanen, Markku ^c   Cooper, Charles ^d   Andrade, Raul J ^e   Watkins, Paul B ^f,g   Lewis, James H ^h   Merz, Michael ⁱ  

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

^b LANDSPITALI UNIVERSITY HOSPITAL   (Iceland)

^c UNIVERSITY OF EASTERN FINLAND   (Finland)

^d Becton Dickenson   (United States)

^e INSTITUTO DE SALUD CARLOS III   (Spain)

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

^g IL   (United States)

^h GEORGETOWN UNIVERSITY   (United States)

ⁱ NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DIAGNOSTIC TEST; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; PATHOLOGY; PHARMACOGENOMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PROTEOMICS; REVIEW; RISK ASSESSMENT; STANDARDIZATION; TOXIC HEPATITIS; WORKSHOP; ANIMAL; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; METABOLISM; METABOLOMICS; METHODOLOGY; PHARMACOGENETICS; PROCEDURES; UNITED STATES;

BIOLOGICAL MARKER;

ANIMALS; BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; DATA COLLECTION; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; METABOLOMICS; PHARMACOGENETICS; PROTEOMICS; RESEARCH DESIGN; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84919919298     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0183-6     Document Type: Review

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