Journal
DRUG DISCOVERY TODAY
Volume 16, Issue 13-14, Pages 600-608Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.drudis.2011.04.011
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Funding
- IMI-JU
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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. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.
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