Understanding Discordance between In Vitro Dissolution, Local Gut and Systemic Bioequivalence of Budesonide in Healthy and Crohn’s Disease Patients through PBPK Modeling

Understanding Discordance between In Vitro Dissolution, Local Gut and Systemic Bioequivalence of Budesonide in Healthy and Crohn’s Disease Patients through PBPK Modeling

The most common method for establishing bioequivalence (BE) is to demonstrate similarity of concentration–time profiles in the systemic circulation, as a surrogate to the site of action. However, similarity of profiles from two formulations in the systemic circulation does not imply similarity in th...

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Bibliographic Details
Main Authors: Chunyan Han, Tiancheng Sun, Siri Kalyan Chirumamilla, Frederic Y. Bois, Mandy Xu, Amin Rostami-Hodjegan
Format: Article
Language:English
Published: MDPI AG 2023-08-01
Series:Pharmaceutics
Subjects:
local bioequivalence
local BE
<i>f</i><sub>2</sub>
virtual bioequivalence
gut-wall exposure
Entocort EC
Online Access:https://www.mdpi.com/1999-4923/15/9/2237

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https://www.mdpi.com/1999-4923/15/9/2237

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