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Letter of support for drug-induced liver injury (DILI) biomarker

The Drug-Induced Liver Injury (DILI) work package 3 (WP3) of the SAFE-T consortium specifically aimed to address the current lack of sensitive and specific clinical tests to diagnose, predict and monitor drug-induced injury to the liver, which is a major hurdle in drug development.


The objectives of DILI WP3 were to qualify one or a set of new biomarkers with respect to:

- an early or earlier diagnosis of DILI as compared to current diagnostic rules

- the ability to predict DILI outcome, with particular emphasis on severe DILI/acute liver failure

- the prognosis and monitoring of progression and regression of DILI

- the differentiation between patients who incur true drug-induced liver injury from those who recover from the initial injury despite ongoing drug treatment (adaptors).

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