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

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Current version

Draft guideline

 

Deadline for comments: 31/10/2017

Reference numberEMA/CHMP/356876/2017
Published03/08/2018
Effective from 
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


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