A generic operational strategy to qualify translational safety biomarkers

Katja Matheis, David Laurie, Christiane Andriamandroso, Nadir Arber, Lina Badimon, Xavier Benain, Kaïdre Bendjama, Isabelle Clavier, Peter Colman, Hüseyin Firat, Jens Goepfert, Steve Hall, Thomas Joos, Sarah Kraus, Axel Kretschmer, Michael Merz, Teresa Padro, Hannes Planatscher, Annamaria Rossi, Nicole Schneiderhan-MarraIna Schuppe-Koistinen, Peter Thomann, Jean Marc Vidal, Béatrice Molac*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Pages (from-to)600-608
Number of pages9
JournalDrug Discovery Today
Issue number13-14
StatePublished - Jul 2011
Externally publishedYes


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