Metformin product-specific bioequivalence guidance

HumanScientific guidelines

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This document provides product-specific guidance on the demonstration of the bioequivalence of Metformin immediate-release film-coated tablets 500, 850 and 1000 mg.

Keywords: Bioequivalence, generics, Metformin

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

Metformin immediate-release film-coated tablets 500, 850 and 1000 mg and 1000 mg/5ml oral solution product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/591346/2022 Rev. 1 Legal effective date:

English (EN) (134.33 KB - PDF)

Prima publicare:
Vizualizare

Document history

Draft metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/591346/2022

English (EN) (141.33 KB - PDF)

Prima publicare:
Vizualizare

Metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/591346/2022 Legal effective date:

English (EN) (139.2 KB - PDF)

Prima publicare:
Vizualizare

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