Biowaiver Monographs - Increasing the world’s access to affordable, quality medicines.Biowaiver Project - Overview
- At: 2012 FIP Congress in Amsterdam (the Netherlands)
- Type: Presentation
- By: SHAH, Vinod (N Potomac, MD, United States of America)
The primary criteria which must be assessed to determine eligibility for the biowaiver relate to its Biopharmaceutics Classification System (BCS), i.e., the solubility of the drug substance at different pH values, its intestinal permeability and the comparative in vitro dissolution profile between the test product and the comparator product. The.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.