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Asymptomatic abnormal liver function tests in clinical trials
Author(s) -
Stephens M. D. B.
Publication year - 1994
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630030206
Subject(s) - medicine , asymptomatic , abnormality , liver function tests , clinical trial , liver function , drug , liver damage , pharmacology , psychiatry
There are many sources of asymptomatic abnormal liver function tests in clinical trials other than hepatotoxicity. It is, therefore, important to identify these sources by looking at the patient's past and present medical history for diseases or activities that may cause these abnormalities, study the degree and duration of the abnormality and the ratio of the different parameters to see whether they are consistent with the hypothesis that the drug is not hepatotoxic and that another cause is more likely. Diseases and activities that can cause these abnormalities are given and methods of analysis outlined. There is no good evidence that abnormal liver function tests are predictive of hepatotoxicity.