Vortioxetine hydrobromide, 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets, vortioxetine lactate, oral drops solution 20 mg / ml product-specific bioequivalence guidance

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Current version

Adopted guideline

Reference numberEMA/CHMP/474974/2016
Published22/12/2016
Effective from01/01/2018
KeywordsBioequivalence, generics, vortioxetine
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of vortioxetine.
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

Current version

Adopted guideline
 
 

Overview of comments
 

Draft guideline

Published: 10/07/2017
Effective from: 01/01/2018
 

Published: 10/07/2017
 

Published: 22/12/2016


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