Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline
Table of contents
This guideline is an addendum to the
Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents
(CPMP/EWP/239/95). The guidance defines requirements for the clinical development of locally applied, locally acting products with known active substance. It provides guidance on the information to be included in the dossier.
Keywords: Therapeutic equivalence, gastrointestinal, locally applied and locally acting, pharmacokinetic, bioequivalence
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Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1 (PDF/455.51 KB)
Adopted
First published: 07/11/2018
Last updated: 29/04/2019
Legal effective date: 30/04/2019
CPMP/EWP/239/95 Rev. 1 Corr. -
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Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents - First version (PDF/38.87 KB)
Adopted
First published: 01/11/1995
Last updated: 01/11/1995
Legal effective date: 01/06/1996
CHMP/EWP/239/95 final
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Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1 (PDF/455.51 KB)
Adopted
First published: 07/11/2018
Last updated: 29/04/2019
Legal effective date: 30/04/2019
CPMP/EWP/239/95 Rev. 1 Corr. -
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Overview of comments received on 'Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract' (EMA/CPMP/EWP/239/95 Rev.1) - Revision 1 (PDF/497.08 KB)
First published: 07/11/2018
EMA/CHMP/648051/2017 -
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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 guidance CHMP/EWP/239/95 - Revision 1 (PDF/318.3 KB)
Draft: consultation closed
First published: 04/04/2017
Last updated: 04/04/2017
Consultation dates: 04/04/2017 to 30/09/2017
CPMP/EWP/239/95 Rev. 1 -
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Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract - Revision 1 (PDF/115.01 KB)
Draft: consultation closed
First published: 01/10/2013
Last updated: 01/10/2013
Consultation dates: 01/10/2013 to 31/12/2013
EMA/CHMP/558326/2013