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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...
Autores principales: | Nagy, CF, Mondick, J, Serbina, N, Casey, LS, Carpenter, SE, French, J, Guttendorf, R |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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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 |
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