This document provides product-specific guidance on the demonstration of the dronedarone.

Keywords: Bioequivalence, generics, dronedarone

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

Current effective version

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