Exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance

  • Email
  • Help
Current version

Adopted guideline

Reference numberEMA/CHMP/474782/2016
Published03/03/2017
Effective from01/09/2017
KeywordsBioequivalence, generics, exenatide
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of exenatide.
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

 

Draft guideline

Effective from: 01/09/2017

 

Published: 01/08/2016


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more