Developing a European framework for research on children's medicines: an examination of the proposed EU regulation on medicinal products for paediatric use

被引：1

作者：

Seyberth, HW ^{[1
]}

Demotes-Mainard, J

Wrobel, P

机构：

[1] Univ Marburg, Marburg, Germany

[2] INSERM, Bordeaux, France

[3] EFGCP, Brussels, Belgium

来源：

PEDIATRIC NEPHROLOGY | 2005年 / 20卷 / 11期

关键词：

Medicine Development; Effective Medicine; Paediatric Clinical Trial; Proposed Regulation; European Clinical Research Infrastructure Network;

D O I：

10.1007/s00467-005-2103-6

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

引用

页码：1537 / 1540

页数：4

共 17 条

[1] Developing a European framework for research on children’s medicines: an examination of the proposed EU regulation on medicinal products for paediatric use
Hannsjörg W. Seyberth
Jacques Demotes-Mainard
Peter Wrobel
Pediatric Nephrology, 2005, 20 : 1537 - 1540
[2] Developing a European Framework for Research on Children's Medicines An Examination of the Proposed EU Regulation on Medicinal Products for Paediatric Use; 25-26 January 2005, Brussels, Belgium
Seyberth, Hannsjoerg W.
Demotes-Mainard, Jacques
Wrobel, Peter
INTERNATIONAL JOURNAL OF PHARMACEUTICAL MEDICINE, 2005, 19 (01): : 37 - 41
[3] Developing a European Framework for Research on Children’s MedicinesAn Examination of the Proposed EU Regulation on Medicinal Products for Paediatric Use; 25–26 January 2005, Brussels, Belgium
Hannsjörg W. Seyberth
Jacques Demotes-Mainard
Peter Wrobel
International Journal of Pharmaceutical Medicine, 2005, 19 (1) : 37 - 41
[4] Availability of new drugs for children: Impact assessment of the European regulation on medicinal products for paediatric use
Blanco Reina, E.
Perez Munoz, C.
Perez Barreales, E.
Stephens, C.
Bellido Estevez, I.
BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2024, 135 : 21 - 22
[5] The EU-regulation on medicinal products for paediatric use -: Impacts on child and adolescent psychiatry and clinical research with minors
Koelch, Michael
Schnoor, Kathlen
Fegert, Joerg M.
EUROPEAN CHILD & ADOLESCENT PSYCHIATRY, 2007, 16 (04) : 229 - 235
[6] The EU-regulation on medicinal products for paediatric useImpacts on child and adolescent psychiatry and clinical research with minors
Michael Kölch
Kathlen Schnoor
Jörg M. Fegert
European Child & Adolescent Psychiatry, 2007, 16 : 229 - 235
[7] Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations
Lehmann B.
Child and Adolescent Psychiatry and Mental Health, 2 (1)
[8] Off-Label Use of Medicines: A Comparative Study on the Regulation of Medicinal Products in Selected European Union Member States
Soares Junior, Wolney da Cunha
EUROPEAN JOURNAL OF RISK REGULATION, 2022, 13 (02) : 311 - 332
[9] Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency’s Committee for Medicinal Products for Human Use
Mark Cilia
Sol Ruiz
Peter Richardson
Tomas Salmonson
Anthony Serracino-Inglott
Francesca Wirth
John Joseph Borg
AAPS PharmSciTech, 2018, 19 : 489 - 511
[10] Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use
Cilia, Mark
Ruiz, Sol
Richardson, Peter
Salmonson, Tomas
Serracino-Inglott, Anthony
Wirth, Francesca
Borg, John Joseph
AAPS PHARMSCITECH, 2018, 19 (02): : 489 - 511

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