Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients

PURPOSE: The current study aimed to illustrate how a non-linear mixed effect (NLME) model-based analysis may improve confidence in a Phase III trial through more precise estimates of the drug effect. METHODS: The FULFIL clinical trial was a Phase III study that compared 24 weeks of once daily inhale...

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Detalles Bibliográficos
Autores principales: Llanos-Paez, Carolina, Ambery, Claire, Yang, Shuying, Beerahee, Misba, Plan, Elodie L., Karlsson, Mats O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314306/
https://www.ncbi.nlm.nih.gov/pubmed/35233731
http://dx.doi.org/10.1007/s11095-022-03194-1

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314306/
https://www.ncbi.nlm.nih.gov/pubmed/35233731
http://dx.doi.org/10.1007/s11095-022-03194-1

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