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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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SAGE Publications
2015
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| 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 |