Clinical trials in pediatric ALS: a TRICALS feasibility study

Clinical trials in pediatric ALS: a TRICALS feasibility study

Background: Pediatric investigation plans (PIPs) describe how adult drugs can be studied in children. In 2015, PIPs for Amyotrophic Lateral Sclerosis (ALS) became mandatory for European marketing-authorization of adult treatments, unless a waiver is granted by the European Medicines Agency (EMA).Obj...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:AMYOTROPHIC LATERAL SCLEROSIS AND FRONTOTEMPORAL DEGENERATION 2022-10, Vol.23 (7-8), p.481-488
Hauptverfasser: Kliest, Tessa, Van Eijk, Ruben P.A, Al-Chalabi, Ammar, Albanese, Alberto, Andersen, Peter M, Amador, Maria Del Mar, BrAthen, Geir, Brunaud-Danel, Veronique, Brylev, Lev, Camu, William, De Carvalho, Mamede, Cereda, Cristina, Cetin, Hakan, Chaverri, Delia, Chio, Adriano, Corcia, Philippe, Couratier, Philippe, De Marchi, Fabiola, Desnuelle, Claude, Van Es, Michael A, Esteban, JesUs, Filosto, Massimiliano, Redondo, Alberto GarcIa, Grosskreutz, Julian, Hanemann, Clemens O, Holmoy, Trygve, Hoyer, Helle, Ingre, Caroline, Koritnik, Blaz, Kuzma-Kozakiewicz, Magdalena, Lambert, Thomas, Leigh, Peter N, Lunetta, Christian, Mandrioli, Jessica, Mcdermott, Christopher J, Meyer, Thomas, Mora, Jesus S, Petri, Susanne, Povedano, M.Onica, Reviers, Evy, Riva, Nilo, Roes, Kit C.B, Rubio, Miguel A, Salachas, FranCois, Sarafov, Stayko, SorarU, Gianni, Stevic, Zorica, Svenstrup, Kirsten, Moller, Anette Torvin, Turner, Martin R, Van Damme, Philip, Van Leeuwen, Lucie A.G, Varona, Luis, Costa, Juan F. V.Azquez, Weber, Markus, Hardiman, Orla, Van den Berg, Leonard H
Format: Artikel
Sprache:eng
Online-Zugang:Volltext bestellen
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:Background: Pediatric investigation plans (PIPs) describe how adult drugs can be studied in children. In 2015, PIPs for Amyotrophic Lateral Sclerosis (ALS) became mandatory for European marketing-authorization of adult treatments, unless a waiver is granted by the European Medicines Agency (EMA).Objective: To assess the feasibility of clinical studies on the effect of therapy in children (
ISSN:2167-8421