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What does the future hold for biowaiver-based drug approval?

  • In: 2G - Biowaiver monographs: increasing access to the world’s affordable, quality medicines on Sunday, 7 October 2012, 12:15-13:45
  • At: Amsterdam (the Netherlands) (2012)
  • Type: Presentation
  • By: DRESSMAN, Jennifer (Goethe University, Institut of Pharmaceutical Technology, Frankfurt am Main, Germany)
  • Abstract:

    The BCS biowaiver was first proposed as an alternative to pharmacokinetic proof of bioequivalence in 1995. Since then, it has been adapted by many, but not all, regulatory authorities across the globe and is becoming increasingly popular as a way of approving generic drug products, to maintain approval of drug products after changes are made and


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Last update 28 September 2023

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