What does the future hold for biowaiver-based drug approval?
- At: Amsterdam (the Netherlands) (2012)
- Type: Presentation
- By: DRESSMAN, Jennifer (Goethe University, Institut of Pharmaceutical Technology, Frankfurt am Main, Germany)
The BCS biowaiver was first proposed as an alternative to pharmacokinetic proof of bioequivalence in 1995. Since then, it has been adapted by many, but not all, regulatory authorities across the globe and is becoming increasingly popular as a way of approving generic drug products, to maintain approval of drug products after changes are made and.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.