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Biomarkers for nonclinical infusion reactions in marketed biotherapeutics and considerations for study design
The observation of an infusion reaction (IR) in a nonclinical study can cause concern among investigators and regulators in the development of biotherapeutics. Biomarkers can be informative to determine whether the reactions are immune-mediated or test-article related and if there is a potential ris...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier B.V
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5893855/ https://www.ncbi.nlm.nih.gov/pubmed/29658009 http://dx.doi.org/10.1016/j.cotox.2017.03.005 |