Rilpivirine product-specific bioequivalence guidance

Current version

PDF iconAdopted guideline

Reference numberEMA/CHMP/356878/2017
Effective from01/08/2018
KeywordsBioequivalence, generics, rilpivirine
DescriptionThis document provides product-specific guidance on the demonstration of the rilpivirine.
  • 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

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/08/2018-present


Published: 01/02/2018


Published: 28/07/2017

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