FDA officials are pondering whether the use of patients’ own baseline liver enzyme data prior to entering a clinical trial may be the preferable way to monitor for drug-induced liver injury in studies.
FDA Could Shift Assessment Of Drug-Induced Liver Injury In Clinical Trials
Agency officials, industry and academia contemplate a new approach to gauging drug-induced liver injury by using individual patients’ baseline liver enzyme measurements, a move that some say could eliminate problems with the use of the upper limit of normal and allow for the assessment of DILI in cases where there is underlying liver injury.
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