Ibuprofen 200 - 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

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Current version

Adopted guideline
 

Adopted guideline enters into effect 01/12/2018 - see below

Reference numberEMA/CHMP/356876/2017
Published26/06/2018
Effective from01/12/2018 
KeywordsBioequivalence, generics, ibuprofen
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of ibuprofen.
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

Adopted guideline


 

Draft guideline

Published: 26/06/2018
Effective from: 01/12/2018

 

Published: 01/08/2016

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