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Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects

The aims of this randomized, double‐blind, three‐arm, single‐dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as “M923”) to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints...

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Vydáno v:Pharmacol Res Perspect
Hlavní autoři: Hillson, Jan, Mant, Tim, Rosano, Molly, Huntenburg, Carolyn, Alai‐Safar, Mehrshid, Darne, Siddhesh, Palmer, Donna, Pavlova, Borislava G., Doralt, Jennifer, Reeve, Russell, Goel, Niti, Weilert, Doris, Rhyne, Paul W., Chance, Kamali, Caminis, John, Roach, James, Ganguly, Tanmoy
Médium: Artigo
Jazyk:Inglês
Vydáno: John Wiley and Sons Inc. 2018
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC5817835/
https://ncbi.nlm.nih.gov/pubmed/29417761
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/prp2.380
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