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...

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Detalles Bibliográficos
Autores principales: Mease, Kirsten M., Kimzey, Amy L., Lansita, Janice A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V 2017
Materias:
Article
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

Internet

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

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