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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)
  • 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 4 October 2019

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