The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

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作者
Annemarie Rosan Kreeftmeijer-Vegter
Anthonius de Boer
Roselinda H van der Vlugt-Meijer
Peter J de Vries
机构
[1] Utrecht University,Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology
[2] ACE Pharmaceuticals BV,Department of Internal Medicine
[3] Tergooi Hospital,undefined
关键词
European paediatric drug regulation; Orphan drug development; Paediatric use; Paediatric investigation plan; Rare diseases;
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