Biomarker qualification new challenge for regulatory authorieties

• In: SIG Posters
• At: Amsterdam (the Netherlands) (2012)
• Type: Poster
• Poster code: RSC-P-06
• By: TUBIC, Biljana (Agency for Medicines and Medical Devices, Department for medicines, Banja Luka, Bosnia and Herzegovina)
• Abstract:

  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

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