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FDA Could Shift Assessment Of Drug-Induced Liver Injury In Clinical Trials

 
• By Sarah Karlin-Smith

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.

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.

Currently, potential injuries are assessed by comparing patients’ data on drug to the liver enzyme values seen in the assumed normal or healthy population, but agency, industry and academic officials...

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