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Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors

Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under...

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Détails bibliographiques
Publié dans:Ther Innov Regul Sci
Auteurs principaux: Klopfenstein, Mitchell, Van Campen, Luann E., Garnett, Timothy
Format: Artigo
Langue:Inglês
Publié: SAGE Publications 2015
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC5802520/
https://ncbi.nlm.nih.gov/pubmed/29473010
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479015578154
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