Dronedarone product-specific bioequivalence guidance

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

KeywordsBioequivalence, generics, dronedarone


  • 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


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