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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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Detalles Bibliográficos
Autor principal: Kimmelman, Jonathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
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