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Animal‐to‐Human Dose Translation of Obiltoxaximab for Treatment of Inhalational Anthrax Under the US FDA Animal Rule

Obiltoxaximab, a monoclonal antibody against protective antigen (PA), is approved for treatment of inhalational anthrax under the US Food and Drug Administration's (FDA) Animal Rule. The human dose was selected and justified by comparing observed obiltoxaximab exposures in healthy and infected...

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Detalhes bibliográficos
Publicado no:Clin Transl Sci
Main Authors: Nagy, CF, Mondick, J, Serbina, N, Casey, LS, Carpenter, SE, French, J, Guttendorf, R
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5245108/
https://ncbi.nlm.nih.gov/pubmed/27925405
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12433
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