Monitoring liver safety in drug development: The GSK experience

Regulatory Toxicology and Pharmacology

Volumn 49, Issue 2, 2007, Pages 90-100

  Hunt, Christine M ^a   Papay, Julie I ^a   Edwards, Rita I ^b   Theodore, Dickens ^a   Alpers, David H ^b,c   Dollery, Colin ^b   DeBruin, Tjerk W ^a   Adkison, Kimberly K ^a   Stirnadel, Heide A ^b   Gibbs, Trevor G ^b  

^a GLAXOSMITHKLINE   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

^c WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Hepatitis B screening; Hepatitis C screening; Hy's Law; Liver chemistries; Liver safety; Safety systems; Transaminase elevation

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BROMFENAC; CYTOCHROME P450 1A; CYTOCHROME P450 2C19; CYTOCHROME P450 2D6; CYTOCHROME P450 3A; CYTOCHROME P450 3A4; DRUG; HEPATITIS B SURFACE ANTIGEN; HEPATITIS C ANTIBODY; TROGLITAZONE; TUBERCULOSTATIC AGENT; VIRUS RNA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALGORITHM; ALKALINE PHOSPHATASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CLINICAL RESEARCH; DRUG RESEARCH; DRUG SAFETY; DRUG WITHDRAWAL; HEPATITIS B; HEPATITIS C; HUMAN; LIVER FAILURE; LIVER FUNCTION; LIVER INJURY; LIVER TOXICITY; NAUSEA; PATIENT MONITORING; PRIORITY JOURNAL; SIDE EFFECT; STANDARD; VOMITING; WORLD HEALTH ORGANIZATION;

ALGORITHMS; CLINICAL TRIALS AS TOPIC; DRUG MONITORING; ENDPOINT DETERMINATION; EVIDENCE-BASED MEDICINE; HUMANS; LIVER; LIVER DISEASES; LIVER FUNCTION TESTS; PHARMACEUTICAL PREPARATIONS; WITHHOLDING TREATMENT;

HEPATITIS C VIRUS;

EID: 35548968827     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2007.06.002     Document Type: Article

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