Ledipasvir/sofosbuvir product-specific bioequivalence guidance

Current version

PDF iconAdopted guideline

Reference numberEMA/CHMP/800789/2017
Published03/08/2018
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.
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


Document history

First version

PDF iconAdopted guideline

 

PDF iconDraft guideline

Published: 03/08/2018

 

Published: 31/01/2018


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