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Fig. 4 | Diagnostic and Prognostic Research

Fig. 4

From: Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study

Fig. 4

Illustration of possible context of use for a new qualified safety biomarker. The flow diagram shows how adverse effects caused by study drugs in premarketing clinical trials could be monitored using current biomarkers and using new biomarkers (or biomarker panel) to establish whether administrated dose can safely continue or requires reduction. New biomarkers may be incorporated into clinical trials to anticipate early risk for progression of hepatocellular injury to severe DILI in individuals where an initial DILI diagnosis has been established based on elevations of current standard markers (e.g. alanine transaminase (ALT), ≥ 5 × ULN, alkaline phosphatase (ALP) ≥ 2 × ULN or ALT ≥ 3 × ULN and total bilirubin (TBL) > 2 × ULN). If biomarker elevation continues, or increases, the drug would be discontinued according to the safety risk mitigation plan; but if levels normalise, drug administration would continue safely. ULN, upper limit of normal

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Diagnostic and Prognostic Research

ISSN: 2397-7523

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