tailieunhanh - Báo cáo y học: "Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về ngành y học đề tài: Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective. | Child and Adolescent Psychiatry and Mental Health BioMed Central Open Access Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation an industry perspective Philippe Auby Address Director International Clinical Research - Paediatric Neuro-Psychiatry Lundbeck SAS 37 avenue Pierre 1er de Serbie 75008 Paris France Email Philippe Auby-phia@ Published 8 December 2008 Received 19 August 2008 Child and Adolescent Psychiatry and Mental Health 2008 2 38 doi l753-2000-2-38 Accepted 8 December 2008 This article is available from http content 2 1 38 2008 Auby licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http licenses by which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Abstract A large proportion of medicines used in children are prescribed off-label and children have often been denied access to new or innovative medications. Because such situation is unethical the need to obtain paediatric information for medicines used in children seems nowadays a matter of consensus on a global basis. Based on this it was clear in EU like what has happened in the US that there was a need for a legal obligation for Pharmaceutical Companies to perform studies. This new European Paediatric Regulation that entered into force in 2007 opens a new era of European drug regulatory history and will offer a major opportunity to improve children s health through advancements in research by providing a new framework for evaluating the efficacy and safety of medicines for children. But paediatric development remains challenging and the hurdles of conducting research in paediatric population are numerous. The article presents the new European Paediatric Regulation illustrates its rationale through paediatric psychopharmacology and discusses some of its .