Experience in the Examination of Bioequivalence Clinical Trials of Locally Applied and Locally Acting Medicinal Products in Accordance with the Eurasian Economic Union Procedures

Experience in the Examination of Bioequivalence Clinical Trials of Locally Applied and Locally Acting Medicinal Products in Accordance with the Eurasian Economic Union Procedures

INTRODUCTION. The examination of protocols for clinical trials of locally applied and locally acting medicinal products highlights challenges that developers face when selecting the design, endpoints, population, comparison groups, and sample size. An analysis of the most common errors in clinical t...

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Bibliographic Details
Main Authors: O. Yu. Ivanova, O. L. Shikhovtsova
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2024-11-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
clinical trials
clinical trial protocol
bioequivalence studies
clinical research evaluation
locally applied and locally acting medicinal products
creams
ointments
gels
corticosteroids
Online Access:https://www.vedomostincesmp.ru/jour/article/view/715
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