The general objective of the project is to qualify new specific and sensitive safety biomarkers for drug-induced kidney, liver and vascular injury to improve safety assessment during drug development. In particular, the purpose of SAFE-T work is to:
- Evaluate the utility of safety biomarkers for monitoring organ safety in humans.
- Develop assays and devices for clinical application of safety biomarkers.
- Gather enough evidence to qualify safety biomarkers in clinical drug development and in translational context in cooperation with the health authorities, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
- Gain evidence for how safety markers may also be used in the diagnosis of diseases and in clinical practice.