Use of Early Clinical Trial Data to Support Thorough QT Study Waiver for Upadacitinib and Utility of Food Effect to Demonstrate ECG Assay Sensitivity

Exposure–response analyses of QT data from early‐stage clinical studies represent a valuable tool to assess the QT prolongation potential for drugs in development in lieu of standalone thorough QT (TQT) studies. However, demonstrating adequate electrocardiogram assay sensitivity can be challenging i...

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Detalles Bibliográficos
Autores principales: Mohamed, Mohamed‐Eslam F., Zeng, Jiewei, Jiang, Ping, Hosmane, Balakrishna, Othman, Ahmed A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946993/
https://www.ncbi.nlm.nih.gov/pubmed/28762476
http://dx.doi.org/10.1002/cpt.804

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946993/
https://www.ncbi.nlm.nih.gov/pubmed/28762476
http://dx.doi.org/10.1002/cpt.804

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