Why the threshold criteria should not be modified for detection of possibly serious drug-induced hepatotoxicity in special groups of trial subjects

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 6, 2013, Pages 579-582

  Senior, John R ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; BILIRUBIN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CANCER PATIENT; CHOLESTASIS; CONSENSUS DEVELOPMENT; DRUG SURVEILLANCE PROGRAM; ENZYME ACTIVITY; FOOD AND DRUG ADMINISTRATION; HUMAN; LIVER CELL DAMAGE; LIVER METASTASIS; MEDICAL RECORD REVIEW; NOTE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PORTAL HYPERTENSION; PRIORITY JOURNAL; STATISTICAL ANALYSIS; TOXIC HEPATITIS; TRUNCATED ROBUST MULTIVARIATE OUTLIER DETECTION ANALYSIS;

ALANINE TRANSAMINASE; BILIRUBIN; CLINICAL TRIALS AS TOPIC; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; MEDICAL ONCOLOGY; MODELS, STATISTICAL;

EID: 84878783956     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3435     Document Type: Note

References (21)

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