Biowaiver based on biopharmaceutics classification system: Considerations and requirements

Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the U...

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Bibliographic Details

Published in:	Pharmaceutical Science Advances
Main Authors:	Pratik R. Dhake, Smita T. Kumbhar, Vinod L. Gaikwad
Format:	Article
Language:	English
Published:	Elsevier 2024-12-01
Subjects:	Biowaiver Biopharmaceutics classification system Bioequivalent Solubility Permeability Generics
Online Access:	http://www.sciencedirect.com/science/article/pii/S2773216923000181