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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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Detalles Bibliográficos
Autores principales: Nagy, CF, Mondick, J, Serbina, N, Casey, LS, Carpenter, SE, French, J, Guttendorf, R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5245108/
https://www.ncbi.nlm.nih.gov/pubmed/27925405
http://dx.doi.org/10.1111/cts.12433