Zonisamide product-specific bioequivalence guidance

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/159882/2016
Published27/05/2016
Effective from01/11/2016
KeywordsBioequivalence, generics, zonisamide
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of zonisamide. Please note that no comments have been received for this guideline during the public consultation period.
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


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/11/2016


Published: 15/07/2015


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