Approved medicines for paediatric solid tumours in Europe: Lessons from the life cycle of a paediatric investigation plan

Background: Despite the positive changes brought by the Paediatric Regulation in the European Union (EU) in 2007, drug development in children remains challenging. Methods: To better understand the issues encountered to reach an authorisation for paediatric patients, we reviewed the pathway of the 1...

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Bibliografische Detailangaben

Hauptverfasser:	Erica Brivio, Dominik Karres, Giovanni Lesa, Franca Ligas
Format:	Artigo
Sprache:	Inglês
Veröffentlicht:	Elsevier 2024-12-01
Schriftenreihe:	EJC Paediatric Oncology
Schlagworte:	Drug development Childhood cancer Paediatric solid tumours Paediatric regulation
Online-Zugang:	http://www.sciencedirect.com/science/article/pii/S2772610X24000503
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