Pediatric Clinical Trials

  • Annagrazia Altavilla
Reference work entry


Over the past decades, drugs have been used in children at different ages, outside the terms of their marketing authorizations in relation to indication, dosage, age, and route of administration, both in Europe and worldwide. The off-label use of drugs exposes children to unexpected adverse reactions or to suboptimal treatment. To develop safe medicines for children, ensuring that pediatric medicines are of high quality, ethically researched, and authorized appropriately, many legislative efforts have been made at European and international level. This chapter will address specific regulatory and ethical aspects included in legal frameworks and ethical guidelines.


European Union Legal Representative Orphan Medicinal Product Market Exclusivity Pediatric Clinical Trial 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Further Reading

  1. Knellwolf AL, Bauzon S, Alberighi OD, Lutsar I, Bácsy E, Alfarez D, Panei P. Framework conditions facilitating paediatric clinical research. Ital J Pediatr. 2011;37:12.PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Espace Éthique Méditerranéen (Bioethics Research Centre UMR 7268)Aix-Marseille University, Hôpital Adultes de la TimoneMarseilleFrance

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