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A theoretical framework for early human studies: uncertainty, intervention ensembles, and boundaries
Clinical development of novel therapeutics begins with a coordinated sequence of early phase clinical trials. Such early human studies confront a series of methodological and ethical challenges. In what follows, I propose a theoretical framework for early human studies aimed at informing the negotia...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2012
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551836/ https://www.ncbi.nlm.nih.gov/pubmed/22999017 http://dx.doi.org/10.1186/1745-6215-13-173 |