Vandetanib product-specific bioequivalence guidance

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/474883/2016
Published03/03/2017
Effective from01/09/2017
KeywordsBioequivalence, generics, vandetanib
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of vandetanib.
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

Effective from: 01/09/2017

Published: 01/08/2016


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