Identification of structure-activity relationships for adverse effects of pharmaceuticals in humans. Part A: Use of FDA post-market reports to create a database of hepatobiliary and urinary tract toxicities

Regulatory Toxicology and Pharmacology

Volumn 54, Issue 1, 2009, Pages 1-22

  Ursem, Carling J ^a,b   Kruhlak, Naomi L ^a   Contrera, Joseph F ^c   MacLaughlin, Philip M ^d   Benz, R Daniel ^a   Matthews, Edwin J ^a  

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

^b GlobalNet Services   (United States)

^c Computational Toxicology Services LLC ^*  (United States)

^d ELSEVIER MASSON   (France)

Author keywords

AERS; Drug induced kidney toxicity; Drug induced liver toxicity; Human adverse effects; Post market reporting; QSAR; Quantitative structure activity relationships; SRS

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; ATAZANAVIR; BILIRUBIN; BOSENTAN; BROMFENAC; CEFRADINE; CHLORZOXAZONE; DANAZOL; DEMECLOCYCLINE; DISULFIRAM; ENFLURANE; ESTAZOLAM; FLUINDOSTATIN; GAMMA GLUTAMYLTRANSFERASE; HALOTHANE; ISOFLURANE; ISONIAZID; LOMUSTINE; NEFAZODONE; OXACILLIN; PEMOLINE; PYRAZINAMIDE; TIABENDAZOLE; TOLCAPONE; TROGLITAZONE; TROVAFLOXACIN; UNINDEXED DRUG; ZILEUTON;

ABDOMINAL PAIN; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASCITES; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BRAIN DISEASE; CHOLESTASIS; CHOLESTATIC HEPATITIS; DATA BASE; DISEASE CLASSIFICATION; DRUG INDUCED DISEASE; DRUG SAFETY; EOSINOPHILIA; FATIGUE; FEVER; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEPATIC COMA; HEPATITIS; HUMAN; HYPERBILIRUBINEMIA; JAUNDICE; LIVER DYSFUNCTION; LIVER FAILURE; LIVER FUNCTION TEST; LIVER INJURY; LIVER NECROSIS; LIVER TOXICITY; MALAISE; MYALGIA; NAUSEA; NEPHROTOXICITY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRURITUS; QUANTITATIVE STRUCTURE ACTIVITY RELATION; SCORING SYSTEM; SENSITIVITY AND SPECIFICITY; SIDE EFFECT; TOXIC HEPATITIS; URINE COLOR; VOMITING; WEAKNESS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BILIARY TRACT DISEASES; CLUSTER ANALYSIS; DATABASES, FACTUAL; ENDPOINT DETERMINATION; HEPATITIS, TOXIC; HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; QUANTITATIVE STRUCTURE-ACTIVITY RELATIONSHIP; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UROLOGIC DISEASES;

EID: 67349161810     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2008.12.009     Document Type: Article

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