Journal of pharmaceutical sciencesHumansAdministrationOralBenzhydryl CompoundsChemistry
Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin.
Reiji Negoya, Mayuki Tsueoka, Xichen Sun, Shuto Nishida, Bertil Abrahamsson, Naseem A Charoo, Rodrigo Cristofoletti, Peter Langguth, Mehul Mehta, Alan Parr, James E Polli, Vinod P Shah, Jennifer Dressman, Atsushi Kambayashi
Published: 202510.1016/j.xphs.2025.104023
Abstract
The objective of this monograph is to assess the applicability of the BCS-based biowaiver for empagliflozin, a sodium glucose co-transporter (SGLT2) inhibitor indicated for the oral management of Type 2 diabetes mellitus. In this assessment, publishe…
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