Ledipasvir/sofosbuvir product-specific bioequivalence guidance

Current version

PDF iconAdopted guideline

Reference numberEMA/CHMP/800789/2017
Effective from01/02/2019
KeywordsBioequivalence, generics, ledipasvir/sofosbuvir
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg.
  • 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

Document history

First version

PDF iconAdopted guideline


PDF iconDraft guideline

Published: 03/08/2018


Published: 31/01/2018

Related content

How useful was this page?

Add your rating