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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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Detalles Bibliográficos
Autores principales:	Klopfenstein, Mitchell, Van Campen, Luann E., Garnett, Timothy
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	SAGE Publications 2015
Materias:	Ethics Special Section
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5802520/ https://www.ncbi.nlm.nih.gov/pubmed/29473010 http://dx.doi.org/10.1177/2168479015578154

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