用于儿科药物研发与评估的药物流行病学研究。
Pharmacoepidemiological research for the development and evaluation of drugs in pediatrics.
作者信息
Kaguelidou Florentia, Durrieu Geneviève, Clavenna Antonio
机构信息
CIC Inserm 1426, Department of pediatric pharmacology and pharmacogenetics, clinical investigations center, hôpital Robert-Debré, 48, boulevard Sérurier, 75019 Paris, France; UMR-1123, ECEVE, Université Paris Diderot, Sorbonne Paris Cité, 75013 Paris, France; Department of pediatric pharmacology and pharmacogenetics, hôpital Robert-Debré, AP-HP, 75019 Paris, France.
Inserm UMR 1027, CIC Inserm 1436, service de pharmacologie médicale et clinique, centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, faculté de médecine, centre hospitalier universitaire, 31000 Toulouse, France.
出版信息
Therapie. 2019 Apr;74(2):315-324. doi: 10.1016/j.therap.2018.09.077. Epub 2019 Jan 31.
New regulations have come into force in Europe and the US establishing the pediatric development as an integral part of the early development of medicinal products. Parallel to the advances in pediatric clinical research, it became obvious that all available sources and research tools to gather valuable information for the safe and efficacious prescription of medicines in children should be used. Real-life, pharmacoepidemiological studies provide information that contribute to the better knowledge of drug utilization, effects and safety in the pediatric population and thereby, a better prescribing in children. In this paper, we suggest some possible applications, provide examples of impact of pharmacoepidemiological and pharmacovigilance studies and expose future perspectives in pediatric pharmacoepidemiology.
欧洲和美国已实施新规定，将儿科药物研发确立为药品早期研发的一个组成部分。随着儿科临床研究的进展，很明显应利用所有可用资源和研究工具，为儿童安全有效用药收集有价值的信息。真实世界的药物流行病学研究提供的信息有助于更好地了解儿科人群的药物使用、疗效和安全性，从而实现更合理的儿童用药。在本文中，我们提出了一些可能的应用，列举了药物流行病学和药物警戒研究产生影响的实例，并阐述了儿科药物流行病学的未来前景。
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