Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents

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Download document Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents
Reference number CPMP/EWP/239/95 Rev. 1
Status draft: consultation open
First published 2017-04-04
Last updated 2017-04-04
Consultation start date 2017-04-04
Consultation end date 2017-09-30
Email address for submissions pkwpsecretariat@ema.europa.eu

Summary

This guideline defines the requirements that need to be fulfilled to waive clinical trials with clinical or pharmacodynamic endpoints in the demonstration of therapeutic equivalence for locally applied, locally acting gastrointestinal products. It also defines the in vivo bioequivalence studies and in vitro equivalence tests that are necessary.