Paclitaxel product-specific bioequivalence guidance - Scientific guideline
Scientific guidelineHumanScientific guidelines
This document provides product-specific guidance on paclitaxel nanoparticle albumin-bound.
Keywords: Bioequivalence, generics, paclitaxel nanoparticle albumin-bound
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