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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...
Autores principales: | Lamba, M, Hutmacher, MM, Furst, DE, Dikranian, A, Dowty, ME, Conrado, D, Stock, T, Nduaka, C, Cook, J, Krishnaswami, S |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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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 |
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