Challenges in the Investigation of Therapeutic Equivalence of Locally Applied/Locally Acting Drugs in the Gastrointestinal Tract: The Rifaximin Case

Challenges in the Investigation of Therapeutic Equivalence of Locally Applied/Locally Acting Drugs in the Gastrointestinal Tract: The Rifaximin Case

<b>Background:</b> Locally acting gastrointestinal (GI) drugs present challenges for generic drug development because traditional bioequivalence measures, which rely on systemic drug levels, do not reflect local efficacy. This review examines regulatory guidelines for establishing therap...

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Bibliographic Details
Main Authors: Georgia Tsakiridou, Antigoni Maria Papanastasiou, Panagiotis Efentakis, Maria Faidra Galini Angelerou, Lida Kalantzi
Format: Article
Language:English
Published: MDPI AG 2025-06-01
Series:Pharmaceutics
Subjects:
locally applied and locally acting products
gastrointestinal track
bioequivalence
rifaximin
Online Access:https://www.mdpi.com/1999-4923/17/7/839
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