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
- 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