Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges - Senior, John R. (Drug safety, 2014)
Keywords: Animals; Biological and medical sciences; Biomarkers; Chemical and Drug Induced Liver Injury - diagnosis; Chemical and Drug Induced Liver Injury - etiology; Chemical and Drug Induced Liver Injury - prevention & control; Clinical trials; Colleges & universities; Diagnosis, Computer-Assisted; Drug Design; Drug Safety and Pharmacovigilance; Drug toxicity and drugs side effects treatment; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drugs; FDA approval; Food; Humans; Liver; Medical sciences; Medicine; Medicine & Public Health; Mortality; Pharmaceutical industry; Pharmacology. Drug treatments; Pharmacology/Toxicology; Product safety; Public private partnerships; Review; Review Article; Risk assessment; Safety-Based Drug Withdrawals - statistics & numerical data; Toxicity: digestive system; United States; United States Food and Drug Administration; United States--US; Adverse Event Reporting System; Bromfenac; Telithromycin; Hepatocellular Injury; Troglitazone; Human; Drug; Evaluation; Liver function; Digestive system; Toxicity; Biological marker; Digestive diseases; Evolution; Hepatic disease; Pharmacovigilance; Food and Drug Administration