Biowaiver Monographs - Increasing the world’s access to affordable, quality medicines.Biowaiver Project - Overview

• In: 2G - Biowaiver monographs: increasing access to the world’s affordable, quality medicines on Sunday, 7 October 2012, 12:15-13:45
• At: Amsterdam (the Netherlands) (2012)
• Type: Presentation
• By: SHAH, Vinod (N Potomac, MD, United States of America)
• Abstract:

  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

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