The pharmacokinetics of three doses of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler
This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant
First published: 16 November 2021
Pharmaceutics | Free Full-Text | Understanding Discordance between In Vitro Dissolution, Local Gut and Systemic Bioequivalence of Budesonide in Healthy
Objectives: The aim of the studies was to assess the bioequivalence of two DPIs containing budesonide and formoterol, being delivered via Elpenhaler® and Turbuhaler®, respectively
Procedure No
Regarding bioequivalence in local GI sections, the duodenum, jejunum and ileum 1 segments are so sensitive to formulation The role of PK studies in establishing bioequivalence (BE) for OIPs has been recently described in every detail
There are 30 ampules in a carton
Medical condition
Objective: To compare the pharmacokinetics of the extended-release MMX® formulation of budesonide (Uceris®) with that of Entocort® EC, an extended (controlled ileal) release formulation of budesonide
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If using this approach, the applicant should provide evidence of high variability in the BE parameters (i
To assess the bioequivalence (AUCinf) of the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA