Lapatinib product-specific bioequivalence guidance

Description: This document provides product-specific guidance on the demonstration of the bioequivalence of lapatinib film-coated tablet 250 mg. This is the second public consultation after significant revision of the draft requirements in response to the comments from the first public consultation.

Key words: Bioequivalence, generics, agomelatine

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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