A generic operational strategy to qualify translational safety biomarkers

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The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. In this article Matheis et al. discuss a generic qualification strategy, established by the IMI SAFE-T consortium, for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.

Suitable processes to qualify biomarkers in clinical studies have not yet been established. The operational qualification strategy described in this article should enable a generation of sufficient clinical evidence for selected kidney, liver and vascular injury biomarker candidates in clinical studies.

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