"Before new drugs are marketed, regulatory authorities must be satisfied that the benefits from the new drug outweigh any harms that might occur. The characterisation and amelioration of potential harms is called Drug Safety Assessment.
Biomarkers are important in Drug Safety Assessment. A Biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic (imaging), or physiologic characteristics are all types of Biomarkers.
Translational research is focussed on the so-called ""translational gaps"" in medical research. It takes laboratory research findings in vitro and in vivo, and uses them to improve the design and interpretation of clinical studies. It takes clinical research findings, and uses them to improve human health. In addition, it takes clinical findings, and uses them to improve the design and interpretation of in vitro and in vivo laboratory studies.
IB4SD-TRISTAN (""TRISTAN"") is a project devised in response to the 7th call for research proposals under IMI 2, on the validation of translational imaging methods in drug safety assessment. TRISTAN aims to improve imaging methods and biomarkers for the prevention, mitigation and management of drug-induced harm to patients in three specific areas. These areas are (1) (WP2) drug-induced changes in fluxes through liver transporters causing drug-induced liver injury (DILI) and drug-drug interactions (DDIs), (2) (WP3) drug-induced interstitial lung disease (DIILD), (3) (WP4) harms arising from mal-distribution of large-molecule drugs.