Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

IntroductionThe European Medicines Agency (EMA) offers scientific advice to support the qualification procedure of novel methodologies, such as preclinical and in vitro models, biomarkers, and pharmacometric methods, thereby endorsing their acceptability in medicine research and development (R&D...

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Principais autores:	Viviana Giannuzzi, Arianna Bertolani, Silvia Torretta, Giorgio Reggiardo, Eleonora Toich, Donato Bonifazi, Adriana Ceci
Formato:	Artigo
Idioma:	Inglês
Publicado:	Frontiers Media S.A. 2024-03-01
Series:	Frontiers in Medicine
Assuntos:	innovative methodologies pediatric research regulatory qualification procedure European Medicines Agency
Acceso en liña:	https://www.frontiersin.org/articles/10.3389/fmed.2024.1369547/full
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