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Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release Tofacitinib

Extended‐release (XR) formulations enable less frequent dosing vs. conventional (e.g., immediate release (IR)) formulations. Regulatory registration of such formulations typically requires pharmacokinetic (PK) and clinical efficacy data. Here we illustrate a model‐informed, exposure–response (E‐R) a...

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Detalles Bibliográficos
Autores principales: Lamba, M, Hutmacher, MM, Furst, DE, Dikranian, A, Dowty, ME, Conrado, D, Stock, T, Nduaka, C, Cook, J, Krishnaswami, S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5485720/
https://www.ncbi.nlm.nih.gov/pubmed/27859030
http://dx.doi.org/10.1002/cpt.576