TY - JOUR AU - Avigan, Mark I AU - Bjornsson, Einar S AU - Pasanen, Markku AU - Cooper, Charles AU - Andrade, Raul J AU - Watkins, Paul B AU - Lewis, James H AU - Merz, Michael PY - 2014 DO - 10.1007/s40264-014-0183-6 UR - http://hdl.handle.net/10668/1881 T2 - Drug Safety AB - A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI... LA - en PB - Springer Verlag KW - Enfermedad hepática Inducida por Drogas KW - Farmacogenética KW - Estándares de referencia KW - Medición de riesgo KW - Pruebas diagnósticas de rutina KW - Ensayos clínicos como asunto KW - Proteómica KW - Medical Subject Headings::Diseases::Digestive System Diseases::Liver Diseases::Drug-Induced Liver Injury KW - Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Weights and Measures::Reference Standards KW - Medical Subject Headings::Disciplines and Occupations::Natural Science Disciplines::Biological Science Disciplines::Pharmacology::Pharmacogenetics KW - Medical Subject Headings::Health Care::Health Services Administration::Organization and Administration::Risk Management::Risk Assessment KW - Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Tests, Routine KW - Medical Subject Headings::Health Care::Health Care Economics and Organizations::Organizations::Government::Federal Government::United States Government Agencies::United States Dept. of Health and Human Services::United States Public Health... KW - Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic KW - Medical Subject Headings::Disciplines and Occupations::Natural Science Disciplines::Biological Science Disciplines::Biochemistry::Proteomics TI - Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. TY - review article ER -