DILI and drug development: A regulatory perspective

Seminars in Liver Disease

Volumn 34, Issue 2, 2014, Pages 215-226

  Avigan, Mark I ^a  

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

Author keywords

biomarkers; clinical trials; drug induced liver injury; hepatotoxicity; postmarketing drug risk evaluation

Indexed keywords

PHARMACOLOGICAL BIOMARKER; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BIOLOGICAL MARKER;

ARTICLE; DRUG DEVELOPMENT; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; LIVER CELL DAMAGE; PHENOTYPE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; TOXIC HEPATITIS; BLOOD; CLINICAL TRIAL (TOPIC); DRUG-INDUCED LIVER INJURY; HUMAN; LEGISLATION AND JURISPRUDENCE; SENTINEL SURVEILLANCE; UNITED STATES;

ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; BILIRUBIN; BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; DRUG-INDUCED LIVER INJURY; HUMANS; LEGISLATION, DRUG; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; SENTINEL SURVEILLANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84901793819     PISSN: 02728087     EISSN: 10988971     Source Type: Journal    
DOI: 10.1055/s-0034-1375961     Document Type: Article

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