Fampridine product-specific bioequivalence guidance
HumanScientific guidelines
This document provides product-specific guidance on the demonstration of the bioequivalence of Fampridine.
Keywords: Bioequivalence, generics, fampridine
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