A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects

ObjectiveThis study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.MethodsThis is a randomized, double-blind, two-arm, parallel study performed to examine the bioequivalence of denosum...

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Principais autores:	Hong Zhang, Min Wu, Xiaoxue Zhu, Cuiyun Li, Xiaojiao Li, Jixuan Sun, Chengjiao Liu, Quan Liu, Wei Wei, Junqi Niu, Yanhua Ding
Formato:	Artigo
Idioma:	Inglês
Publicado:	Frontiers Media S.A. 2020-10-01
Series:	Frontiers in Pharmacology
Assuntos:	denosumab biosimilar immunogenicity pharmacokinetics pharmacodynamics inter-subject variability
Acceso en liña:	https://www.frontiersin.org/article/10.3389/fphar.2020.01329/full
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