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Non-biological complex drugs: science-based approaches to assessing therapeutic equivalence

  • At: 2014 FIP Congress in Bangkok (Thailand)
  • Type: Poster
  • By: MüHLEBACH, Stefan (Vifor Pharma Ltd, Global Regulatory Affairs, Glattbrugg, Switzerland)
  • Co-author(s): Borchard, Gerrit (School of Pharmacy, University of Geneva, Geneva, Switzerland)
    Flühmann, Beat (Vifor Pharma Ltd, Glattbrugg, Switzerland)
  • Abstract:

    I. Background: Non-biological complex drug (NBCDs) include liposomes, low molecular weight heparins, glatiramoids and iron-carbohydrate drugs.
    II. Aims: Proposal of a regulatory approach to assure quality and safety of intended copies.
    III. Methods: NBCDs include mixtures of macromolecules that cannot be fully characterized. As shown for..

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Last update 4 October 2019

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