A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects

Lee, HA; Kim, S; Seo, H; Kim, S

Lee, HA (通讯作者)，Samsung Bioepis Co Ltd, Clin Developement Grp, 76,Songdogyoyuk Ro, Incheon 21987, South Korea.

EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2023; 32 (10): 959

Abstract

BackgroundSB16 is a biosimilar to reference denosumab (DEN). This study assessed pharmacokinetic (PK) equivalence and evaluated pharmacodynamic (PD), ......

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