Cargando…
Clinical Evaluation of Humira(®) Biosimilar ONS-3010 in Healthy Volunteers: Focus on Pharmacokinetics and Pharmacodynamics
ONS-3010 is being developed by Oncobiologics Inc. (Cranbury, NJ, USA) as a biosimilar of Humira(®). This randomized, double blind, single-center phase I study (EudraCT registration # 2013-003551-38) was performed to demonstrate pharmacokinetic (PK) biosimilarity between two reference products (Humir...
Autores principales: | Dillingh, Marlous R., Reijers, Joannes A. A., Malone, Karen E., Burggraaf, Jacobus, Bahrt, Kenneth, Yamashita, Liz, Rehrig, Claudia, Moerland, Matthijs |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124695/ https://www.ncbi.nlm.nih.gov/pubmed/27965661 http://dx.doi.org/10.3389/fimmu.2016.00508 |
Ejemplares similares
-
Remarkable Pharmacokinetics of Monoclonal Antibodies: A Quest for an Explanation
por: Reijers, Joannes A. A., et al.
Publicado: (2016) -
Adverse immunostimulation caused by impurities: The dark side of biopharmaceuticals
por: Reijers, Joannes A. A., et al.
Publicado: (2019) -
Potential Influence of Endothelial Adsorption on the Delayed Time to Maximum Concentration of Biopharmaceuticals
por: Reijers, Joannes A. A., et al.
Publicado: (2017) -
Trastuzumab Induces an Immediate, Transient Volume Increase in Humans: A Randomised Placebo-Controlled Trial
por: Reijers, Joannes A.A., et al.
Publicado: (2015) -
Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies
por: Reijers, Joannes A. A., et al.
Publicado: (2016)