Causality Assessment for Suspected DILI During Clinical Phases of Drug Development

Drug Safety

Volumn 37, Issue 1, 2014, Pages 47-56

  Regev, Arie ^a   Seeff, Leonard B ^b   Merz, Michael ^c   Ormarsdottir, Sif ^d   Aithal, Guruprasad P ^e   Gallivan, Jim ^f   Watkins, Paul B ^g,h  

^a ELI LILLY AND COMPANY   (United States)

^b Einstein Healthcare Network   (United States)

^c NOVARTIS PHARMA AG   (Switzerland)

^d ASTRAZENECA R AND D   (Sweden)

^e NIHR NOTTINGHAM BIOMEDICAL RESEARCH CENTRE   (United Kingdom)

^f HEALTH CANADA   (Canada)

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

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

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; HERBACEOUS AGENT; IMMUNOMODULATING AGENT; IMMUNOSUPPRESSIVE AGENT; NEW DRUG; STEROID;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANAMNESIS; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL EVALUATION; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DATA COLLECTION METHOD; DEATH; DISEASE COURSE; DISEASE SEVERITY; DRUG DESIGN; DRUG MONITORING; DRUG SAFETY; HUMAN; LATENT PERIOD; LIVER FUNCTION TEST; LIVER GRAFT; LIVER INJURY; PUBLICATION; RATING SCALE; REVIEW; RISK ASSESSMENT; RISK FACTOR; ROUSSEL UCLAF CAUSALITY ASSESSMENT METHOD; SCORING SYSTEM; STANDARDIZATION; STEROID THERAPY; TOXIC HEPATITIS; TREATMENT INDICATION; WORKSHOP; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; PATHOLOGY; POSTMARKETING SURVEILLANCE; PROCEDURES;

CLINICAL TRIALS AS TOPIC; DRUG DESIGN; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 84919909591     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0185-4     Document Type: Review

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