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Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects

AIMS: This study aimed to demonstrate that the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Sandoz proposed biosimilar pegfilgrastim (LA‐EP2006) matches reference pegfilgrastim (Neulasta(®)) in healthy subjects. Safety and immunogenicity were also assessed. METHODS: The phase I, randomiz...

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Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:Br J Clin Pharmacol
Prif Awduron: Nakov, Roumen, Gattu, Sreekanth, Wang, Jessie, Velinova, Maria, Schaffar, Gregor, Skerjanec, Andrej
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: John Wiley and Sons Inc. 2018
Pynciau:
Mynediad Ar-lein:https://ncbi.nlm.nih.gov/pmc/articles/PMC6256001/
https://ncbi.nlm.nih.gov/pubmed/30079636
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13731
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