Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence guidance

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/805532/2016
Published10/07/2017
Effective from01/01/2018
KeywordsBioequivalence, generics, emtricitabine, rilpivirine, tenofovir disoproxil
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of emtricitabine, rilpivirine, tenofovir disoproxil.
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


Document history

First version
Current version

PDF iconAdopted guideline

PDF iconDraft guideline

Published: 10/07/2017
Effective from: 01/01/2018

Published: 22/12/2016


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