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Pharmacodynamics, safety, and immunogenicity of Pelmeg(®), a pegfilgrastim biosimilar in healthy subjects

A pharmacodynamics (PD) and immunogenicity study was conducted to investigate biosimilarity of Pelmeg(®), a pegfilgrastim biosimilar to EU‐authorized Neulasta(®). The multiple‐dose, randomized, double‐blind, two‐sequence, and three‐period cross‐over study comprised 96 healthy male subjects, receivin...

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Publicado en:Pharmacol Res Perspect
Autores principales: Wessels, Hendrik, Lehnick, Dirk, Höfler, Josef, Jankowsky, Ruediger, Chamberlain, Paul, Roth, Karsten
Formato: Artigo
Lenguaje:Inglês
Publicado: John Wiley and Sons Inc. 2019
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Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC6691755/
https://ncbi.nlm.nih.gov/pubmed/31417681
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/prp2.507
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