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Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial

BACKGROUND: HX575 is a human recombinant epoetin alfa that was approved for use in Europe in 2007 under the European Medicines Agency biosimilar approval pathway. Therefore, in order to demonstrate the bioequivalence of HX575 to an existing epoetin alfa, the pharmacokinetic and pharmacodynamic respo...

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Detalhes bibliográficos
Main Authors: Sörgel, Fritz, Thyroff-Friesinger, Ursula, Vetter, Andrea, Vens-Cappell, Bernhard, Kinzig, Martina
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2009
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Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2695417/
https://ncbi.nlm.nih.gov/pubmed/19463151
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1472-6904-9-10
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