Lurasidone product-specific bioequivalence guidance
HumanScientific guidelines
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This document provides product-specific guidance on the demonstration of the bioequivalence of Lurasidone film-coated tablets 18.5, 37 and 74 mg.
Keywords: Bioequivalence, generics, lurasidone
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