Assessing the Interchangeability of AVT02 and Humira(®) in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study

BACKGROUND: The US Food and Drug Administration (FDA) interchangeability guidelines state that the primary endpoint in a switching study should assess the impact of switching between the proposed interchangeable product and the reference product on clinical pharmacokinetics (PK) and pharmacodynamics...

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Detalles Bibliográficos
Autores principales: Feldman, Steven R., Kay, Richard, Reznichenko, Nataliya, Sobierska, Joanna, Dias, Roshan, Otto, Hendrik, Haliduola, Halimu N., Sattar, Abid, Ruffieux, Ruth, Stroissnig, Heimo, Berti, Fausto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10197027/
https://www.ncbi.nlm.nih.gov/pubmed/37204631
http://dx.doi.org/10.1007/s40259-023-00600-x

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