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)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.