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

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&a...

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Bibliographic Details
Main Authors: Viviana Giannuzzi, Arianna Bertolani, Silvia Torretta, Giorgio Reggiardo, Eleonora Toich, Donato Bonifazi, Adriana Ceci
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-03-01
Series:Frontiers in Medicine
Subjects:
innovative methodologies
pediatric research
regulatory
qualification procedure
European Medicines Agency
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2024.1369547/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2024.1369547/full

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