Which Substances are Eligible for the Biowaiver?
- At: 2012 FIP Congress in Amsterdam (the Netherlands)
- Type: Presentation
- By: NAIR, Anita (Goethe Universität, Institute of Pharmaceutical Technology, Frankfurt, Germany)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.