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欧洲儿科制剂倡议组织(EuPFI)——为儿童研发更优质药物的构想

European Paediatric Formulation Initiative (EuPFI)-Formulating Ideas for Better Medicines for Children.

作者信息

Salunke Smita, Liu Fang, Batchelor Hannah, Walsh Jenny, Turner Roy, Ju Tzuchi Rob, Tuleu Catherine

机构信息

Department of Pharmaceutics & Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, 29-39 Brunswick Square, London, WC1N 1AX, UK.

Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, AL10 9AB, UK.

出版信息

AAPS PharmSciTech. 2017 Feb;18(2):257-262. doi: 10.1208/s12249-016-0584-1. Epub 2016 Jul 15.

DOI:10.1208/s12249-016-0584-1
PMID:27422653
Abstract

The European Paediatric Formulation Initiative (EuPFI), founded in 2007, aims to promote and facilitate the preparation of better and safe medicines for children through linking research and information dissemination. It brings together the capabilities of the industry, academics, hospitals, and regulators within a common platform in order to scope the solid understanding of the major issues, which will underpin the progress towards the future of paediatric medicines we want.The EuPFI was formed in parallel to the adoption of regulations within the EU and USA and has served as a community that drives research and dissemination through publications and the organisation of annual conferences. The membership and reach of this group have grown since its inception in 2007 and continue to develop and evolve to meet the continuing needs and ambitions of research into and development of age appropriate medicines. Five diverse workstreams (age-appropriate medicines, Biopharmaceutics, Administration Devices, Excipients and Taste Assessment & Taste Masking (TATM)) direct specific workpackages on behalf of the EuPFI. Furthermore, EuPFI interacts with multiple diverse professional groups across the globe to ensure efficient working in the area of paediatric medicines. Strong commitment and active involvement of all EuPFI stakeholders have proved to be vital to effectively address knowledge gaps related to paediatric medicines, discuss potential areas for further research and identify issues that need more attention and analysis in the future.

摘要

欧洲儿科制剂倡议组织(EuPFI)成立于2007年,旨在通过联系研究与信息传播,促进并推动为儿童制备更优质、安全的药物。该组织将行业、学术界、医院及监管机构的能力汇聚于一个共同平台,以便全面深入了解主要问题,这些问题将为我们迈向理想的儿科药物未来奠定基础。EuPFI与欧盟和美国法规的采用同步形成,并作为一个通过出版物及组织年度会议来推动研究与传播的团体发挥作用。自2007年成立以来,该组织的成员数量及影响力不断增长,并持续发展演变,以满足对适合儿童年龄药物研发研究的持续需求与抱负。五个不同的工作流(适合儿童年龄的药物、生物药剂学、给药装置、辅料以及味觉评估与掩味(TATM))代表EuPFI指导特定的工作包。此外,EuPFI与全球多个不同的专业团体互动,以确保在儿科药物领域高效开展工作。事实证明,EuPFI所有利益相关者的坚定承诺和积极参与对于有效填补与儿科药物相关的知识空白、讨论进一步研究的潜在领域以及确定未来需要更多关注和分析的问题至关重要。

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