A pre-marketing ALT signal predicts post-marketing liver safety

Regulatory Toxicology and Pharmacology

Volumn 63, Issue 3, 2012, Pages 433-439

  Moylan, Cynthia A ^a,b   Suzuki, Ayako ^a   Papay, Julie I ^c   Yuen, Nancy A ^c   Ames, Michael ^c   Hunt, Christine M ^c  

^a DUKE UNIVERSITY   (United States)

^b DURHAM VA MEDICAL CENTER   (United States)

^c GLAXOSMITHKLINE   (United States)

Author keywords

Adverse Event Reporting System; Alanine aminotransferase; Drug induced liver injury; Food and Drug Administration; Hepatotoxicity; New drug application

Indexed keywords

ACAMPROSATE; ACARBOSE; ALANINE AMINOTRANSFERASE; ALEFACEPT; BOSENTAN; DARIFENACIN; ELETRIPTAN; EPLERENONE; ESZOPICLONE; EZETIMIBE; FENOFIBRATE; FROVATRIPTAN; GALANTAMINE; INFLIXIMAB; LEFLUNOMIDE; MEVINOLIN; NEVIRAPINE; OLANZAPINE; OLMESARTAN; PALIPERIDONE; PEGVISOMANT; PIOGLITAZONE; PLACEBO; PRAVASTATIN; RAMELTEON; ROSIGLITAZONE; SIMVASTATIN; UNINDEXED DRUG; ZIDOVUDINE; ZILEUTON;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; DRUG APPROVAL; DRUG INFORMATION; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; LIVER METABOLISM; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; PREDICTION; PREDICTIVE VALUE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REFERENCE VALUE; RETROSPECTIVE STUDY; RISK ASSESSMENT; SIDE EFFECT; TOXIC HEPATITIS;

ALANINE TRANSAMINASE; DRUG APPROVAL; DRUG-INDUCED LIVER INJURY; HUMANS; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862603638     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.05.016     Document Type: Article

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