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Pathogen-focused Clinical Development to Address Unmet Medical Need: Cefiderocol Targeting Carbapenem Resistance

Historically, the regulatory requirements of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for developing new antibiotics have not addressed pathogen-focused indications for drug approval. The design of the necessary randomized controlled trials traditionally invo...

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Detalles Bibliográficos
Autores principales:	Echols, Roger, Ariyasu, Mari, Nagata, Tsutae Den
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Oxford University Press 2019
Materias:	Supplement Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6853756/ https://www.ncbi.nlm.nih.gov/pubmed/31724048 http://dx.doi.org/10.1093/cid/ciz829

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