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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...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer US
2022
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| Materias: | |
| 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 |