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Which Substances are Eligible for the Biowaiver?

  • 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: NAIR, Anita (Goethe Universität, Institute of Pharmaceutical Technology, Frankfurt, Germany)
  • Abstract:

    The Biopharmaceutical Classification (BCS) system classifies drugs based on its permeability and solubility into four distinct classes. Adopting the BCS as a basis, the US FDA, WHO and the EMA has put forth guidances where in vitro ; dissolution tests can be used as a surrogate to in vivo ; studies in order to evaluate the bioequivalence of


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Last update 28 September 2023

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