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Patient-reported outcome claims in European and United States orphan drug approvals

Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan d...

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Foilsithe in:J Mark Access Health Policy
Main Authors: Jarosławski, Szymon, Auquier, Pascal, Borissov, Borislav, Dussart, Claude, Toumi, Mondher
Formáid: Artigo
Teanga:Inglês
Foilsithe: Routledge 2018
Ábhair:
Rochtain Ar Líne:https://ncbi.nlm.nih.gov/pmc/articles/PMC6225506/
https://ncbi.nlm.nih.gov/pubmed/30425804
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/20016689.2018.1542920
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