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Abstract

Promise of new translational safety biomarkers in drug development and some challenges to regulatory qualification

Author(s): Frank D Sistare, Joseph J DeGeorge

One promise of new translational safety biomarkers (TSBs) is their ability to demonstrate that toxicities in animal studies are monitorable at an early stage, such that human relevance of potential adverse effects of drugs can be safely and definitively evaluated in clinical trials.


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