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Pharmacokinetic similarity of biologics: analysis using nonlinear mixed-effects modeling

Our objective was to show with two examples that a pharmacokinetic (PK) similarity analysis can be performed with nonlinear mixed effects models (NLMEM). We used two studies comparing different biosimilars: a three-way crossover trial on somatropin and a parallel group trial on epoetin alpha. For bo...

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Detalhes bibliográficos
Main Authors: Dubois, Anne, Gsteiger, Sandro, Balser, Sigrid, Pigeolet, Etienne, Steimer, Jean-Louis, Pillai, Goonaseelan, Mentré, France
Formato: Artigo
Idioma:Inglês
Publicado em: Nature Pub. Group 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3400548/
https://ncbi.nlm.nih.gov/pubmed/22205196
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/clpt.2011.216
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