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Planning a Clinical Development Programme for Medicinal Products for Irritable Bowel Syndrome: An Analysis of the European Medicines Agency’s Recommendations

INTRODUCTION. Irritable bowel syndrome (IBS) is a chronic functional disorder present in over 13% of the population. Despite the wide prevalence of IBS, there is currently a lack of well characterised authorised medicinal products to treat IBS. This situation stems from both poor engagement in the d...

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Principais autores: E. A. Gerasimets, N. A. Rumyantsev, R. S. Ilin, D. V. Goryachev
Format: Artigo
Sprog:Russo
Udgivet: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2024-09-01
Serier:Регуляторные исследования и экспертиза лекарственных средств
Fag:
clinical trials
irritable bowel syndrome
diarrhoea
constipation
safety and efficacy evaluation
primary endpoint
rome iv criteria
Online adgang:https://www.vedomostincesmp.ru/jour/article/view/635
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