Paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance

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Current version

Adopted guideline

Reference numberEMA/CHMP/474825/2016
Published03/03/2017
Effective from01/09/2017
KeywordsBioequivalence, generics, paliperidone
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of paliperidone.
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

Adopted guideline

 

Overview of comments

 

Draft guideline

Effective from: 01/09/2017

 

Published: 03/03/2017

 

Published: 01/08/2016


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