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Population Pharmacokinetic and Pharmacodynamic Model-Based Comparability Assessment of a Recombinant Human Epoetin Alfa and the Biosimilar HX575

The aim of this study was to develop an integrated pharmacokinetic and pharmacodynamic (PK/PD) model and assess the comparability between epoetin alfa HEXAL/Binocrit (HX575) and a comparator epoetin alfa by a model-based approach. PK/PD data—including serum drug concentrations, reticulocyte counts,...

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Detalhes bibliográficos
Main Authors: Yan, Xiaoyu, Lowe, Philip J., Fink, Martin, Berghout, Alexander, Balser, Sigrid, Krzyzanski, Wojciech
Formato: Artigo
Idioma:Inglês
Publicado em: 2011
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3483448/
https://ncbi.nlm.nih.gov/pubmed/22162538
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/0091270011421911
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