Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Keywords: Bioequivalence, generics, pegylated liposomal doxorubicin hydrochloride

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

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