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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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| Publié dans: | Ther Innov Regul Sci |
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| Auteurs principaux: | , , |
| Format: | Artigo |
| Langue: | Inglês |
| Publié: |
SAGE Publications
2015
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| 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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