Biomarker qualification new challenge for regulatory authorieties
- At: 2012 FIP Congress in Amsterdam (the Netherlands)
- Type: Poster
- By: TUBIC, Biljana (Agency for Medicines and Medical Devices, Department for medicines, Banja Luka, Bosnia and Herzegovina)
I. The use of biomarkers in drug discovery, development and post-approval has the potential to facilitate the development of safer and more effective drugs, to guide dose selection, and to enhance the risk-benefit profile of approved drugs. Biomarker qualification is inevitably individualized — the type and weight of evidence is specific to a.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.