Prasugrel product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, prasugrel

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 - Revision 1

How useful was this page?

Add your rating