Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved ATMPs in the EU. A systematic review of the c...

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Autori principali:	Carolina Iglesias-Lopez, Antònia Agustí, Antonio Vallano, Merce Obach
Natura:	Artigo
Lingua:	Inglês
Pubblicazione:	Frontiers Media S.A. 2021-11-01
Serie:	Frontiers in Pharmacology
Soggetti:	drug development drug approval research design methods clinical trials advanced therapies
Accesso online:	https://www.frontiersin.org/articles/10.3389/fphar.2021.773712/full
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