TROIKA‐1: A double‐blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU‐Herceptin(®) and US‐Herceptin(®) in healthy male subjects

Prestige Biopharma Ltd (Singapore) has developed HD201, a proposed biosimilar to reference product trastuzumab. As a part of the stepwise approach to ensure comparability between the biosimilar candidate and the reference medicinal product, a phase I study in healthy subjects was conducted to demons...

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Detalles Bibliográficos
Autores principales: Demarchi, Martin, Coliat, Pierre, Mclendon, Kristi, Chung Shii Hii, Jocelyn, Feyaerts, Peggy, Ang, Felicia, Jaison, Litha, Deforce, Filip, Derde, Marie Paule, Kim, Michael Jinwoo, Park, Lisa Soyeon, Detappe, Alexandre, Pivot, Xavier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311913/
https://www.ncbi.nlm.nih.gov/pubmed/34309241
http://dx.doi.org/10.1002/prp2.839

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