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

• In: Posters: Regulatory Sciences
• At: Bangkok (Thailand) (2014)
• Type: Poster
• Poster code: POS-RSC006
• 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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