Paediatric drug development and evaluation: Existing challenges and recommendations

Author:

Kaguelidou Florentia,Ouèdraogo Maria,Treluyer Jean-Marc,Le Jeunne Claire,Annereau Maxime,Blanc Patricia,Bureau Serge,Ducassou Stéphane,Fiquet Béatrice,Flamein Florence,Gaillard Ségolène,Hankard Regis,Laugel Vincent,Laurent Corinne,Levy Corinne,Marquet Thierry,Polak Michel,Portefaix Aurélie,Vassal Gilles

Publisher

Elsevier BV

Subject

Pharmacology (medical)

Reference54 articles.

1. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. https://eur-lex.europa.eu/homepage.html [Accessed18 November 2022].

2. Global research in pediatrics. Paediatric drug development: the impact of evolving regulations;Turner;Adv Drug Deliv Rev,2014

3. Enabling development of paediatric medicines in Europe: 10 years of the EU paediatric regulation;Tomasi;Paediatr Drugs,2017

4. Drug evaluation in children 10 years after the European pediatric regulation current challenges and perspectives;Elie;Therapie,2018

5. Failed pediatric drug development trials;Momper;Clin Pharmacol Ther,2015

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