GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes

AIMS: To assess pharmacokinetics (PK) and safety of GP2015, a proposed etanercept biosimilar, in two studies: comparison with etanercept originator (ETN, bioequivalence study) and comparison of GP2015 administered via an autoinjector (AI) or prefilled syringes (PFS, delivery study). METHODS: Both st...

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Enregistré dans:
Détails bibliographiques
Publié dans:Br J Clin Pharmacol
Auteurs principaux: von Richter, Oliver, Skerjanec, Andrej, Afonso, Miguel, Sanguino Heinrich, Sabine, Poetzl, Johann, Woehling, Heike, Velinova, Maria, Koch, Annelize, Kollins, Dmitrij, Macke, Lars, Wuerth, Guido
Format: Artigo
Langue:Inglês
Publié: John Wiley and Sons Inc. 2016
Sujets:
Clinical Trials
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC5346872/
https://ncbi.nlm.nih.gov/pubmed/27790726
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13170
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