MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects

• 主要な著者: Monika Tomaszewska‐Kiecana (著者), Elisabete Carapuça (著者), Amalia Florez‐Igual (著者), Javier Queiruga‐Parada (著者)
• フォーマット: 図書
• 出版事項: Wiley, 2024-09-01T00:00:00Z.
• 主題: article
• オンライン･アクセス: Connect to this object online.

Abstract This was a Phase I, randomized, double‐blinded, three‐arm, single‐dose, parallel study aimed to demonstrate pharmacokinetic (PK) similarity between MB09 (a denosumab biosimilar candidate) and reference denosumab (XGEVA® from European Union [EU‐reference] and United States [US‐reference]) in...