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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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Last update 28 September 2023

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