Ledipasvir/sofosbuvir product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg.

KeywordsBioequivalence, generics, ledipasvir/sofosbuvir


  • 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


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