Eltrombopag product-specific bioequivalence guidance

HumanScientific guidelines

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This document provides product-specific guidance on the demonstration of the bioequivalence of eltrombopag.

Keywords: bioequivalence, generics, eltrombopag

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

Current version

Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/226445/2025 Legal effective date:

English (EN) (156.94 KB - PDF)

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Document history

Draft eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: to Reference Number: EMA/226445/2025

English (EN) (154.58 KB - PDF)

Első közzététel:
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