Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges

Drug Safety

Volumn 37, Issue 1, 2014, Pages 9-17

  Senior, John R ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALATROFLOXACIN; BILIRUBIN; BROMFENAC; CERIVASTATIN; MIBEFRADIL; NEW DRUG; SIBUTRAMINE; TROGLITAZONE; TROVAFLOXACIN;

CLINICAL TRIAL (TOPIC); COMPUTER PROGRAM; DISEASE SEVERITY; DRUG APPROVAL; DRUG INDUSTRY; DRUG SAFETY; EVOLUTION; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERNET; JAUNDICE; LIVER CELL DAMAGE; LIVER FUNCTION; LIVER FUNCTION TEST; LIVER TOXICITY; MEDICAL SOCIETY; MORTALITY; POSTMARKETING SURVEILLANCE; REVIEW; TOXIC HEPATITIS; WORKSHOP; ANIMAL; COMPUTER ASSISTED DIAGNOSIS; DRUG DESIGN; DRUG RECALL; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; STATISTICS AND NUMERICAL DATA; UNITED STATES;

ANIMALS; DIAGNOSIS, COMPUTER-ASSISTED; DRUG DESIGN; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; SAFETY-BASED DRUG WITHDRAWALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84919924873     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0182-7     Document Type: Review

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