Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline

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