Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance

  • Email
  • Help
Current version

Draft guideline

Deadline for comments: 31/10/2017

Reference numberEMA/CHMP/356875/2017
Published28/07/2017
Effective from 
KeywordsBioequivalence, generics, dronedarone
DescriptionThis document provides product-specific guidance on the demonstration of the dronedarone.
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


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more