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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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Dades bibliogràfiques
Publicat a:Clin Infect Dis
Autors principals: Echols, Roger, Ariyasu, Mari, Nagata, Tsutae Den
Format: Artigo
Idioma:Inglês
Publicat: Oxford University Press 2019
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC6853756/
https://ncbi.nlm.nih.gov/pubmed/31724048
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1093/cid/ciz829
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