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Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

BACKGROUND: CT‐P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT‐P39 to European Union‐approved and United States‐licensed reference omalizumab (EU‐ and US‐omalizumab, respectively). METHODS: This two‐part, randomised, pa...

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Detalles Bibliográficos
Autores principales: Maurer, Marcus, Saini, Sarbjit S., McLendon, Kristi, Wabnitz, Paul, Kim, Sunghyun, Ahn, Keumyoung, Kim, Suyoung, Lee, Sewon, Grattan, Clive
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9665328/
https://www.ncbi.nlm.nih.gov/pubmed/36434739
http://dx.doi.org/10.1002/clt2.12204