Metformin product-specific bioequivalence guidance
HumanScientific guidelines
This document provides product-specific guidance on the demonstration of the bioequivalence of Metformin immediate-release film-coated tablets 500, 850 and 1000 mg.
Keywords:Â Bioequivalence, generics, Metformin
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration