Pirfenidone product-specific bioequivalence guidance
HumanScientific guidelines
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This document provides product-specific guidance on the demonstration of the bioequivalence of Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg.
Keywords: Bioequivalence, generics, Pirfenidone
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