Ledipasvir/sofosbuvir product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg.
Keywords: Bioequivalence, generics, ledipasvir/sofosbuvir
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- Cmax: maximum plasma concentration