Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis

In the development process for new drugs, dose‐finding studies are of major importance. Absence of these studies may lead to failed phase 3 trials and delayed marketing authorization. In our study we investigated to what extent dose‐finding studies are performed in the case of orphan drugs for metab...

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Foilsithe in:J Clin Pharmacol
Main Authors: Schuller, Yvonne, Gispen‐de Wied, Christine, Hollak, Carla E. M., Leufkens, Hubertus G. M., Stoyanova‐Beninska, Violeta
Formáid: Artigo
Teanga:Inglês
Foilsithe: John Wiley and Sons Inc. 2018
Ábhair:
Orphan Drugs
Rochtain Ar Líne:https://ncbi.nlm.nih.gov/pmc/articles/PMC6585723/
https://ncbi.nlm.nih.gov/pubmed/30192386
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/jcph.1304
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