Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab

BackgroundThis analysis aims to evaluate the population pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab and applied a population PK/PD approach to assess the biosimilarity of SB16 in comparison to reference product, denosumab (DEN).MethodsPooled serum concentrations data for SB16 and DE...

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Principais autores:	Seungchan Choi, Suemin Park, Jinah Jung, Siook Baek, Hyeong-Seok Lim
Formato:	Artigo
Idioma:	Inglês
Publicado em:	Frontiers Media S.A. 2025-08-01
coleção:	Frontiers in Pharmacology
Assuntos:	denosumab biosimilar target-mediated drug disposition osteoporosis PK/PD modeling and simulation monolix
Acesso em linha:	https://www.frontiersin.org/articles/10.3389/fphar.2025.1631034/full
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