This document provides product-specific guidance on the demonstration of the bioequivalence of repaglinide. Please note that no comments have been received for this guideline during the public consultation period.

Keywords: Bioequivalence, generics, repaglinide

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 effective version

Repaglinide tablets 0.5, 1 and 2 mg product-specific bioequivalence guidance

DraftFirst published: Last updated: Reference Number: EMA/CHMP/675842/2014 Legal effective date: Summary:

This document provides product-specific guidance on demonstration of bioequivalence of repaglinide

English (EN) (78.05 KB - PDF)View

Document history

Draft repaglinide product-specific bioequivalence guidance

Draft: consultation closedFirst published: Last updated: Consultation dates: to Reference Number: CHMP/PKWP/EMA/422421/2013Summary:

Repaglinide product-specific bioequivalence guidance

English (EN) (80.52 KB - PDF)View

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