Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

After multiple drugs were removed from the market secondary to drug‐induced torsade de pointes (TdP) risk, the International Council for Harmonisation (ICH) released guidelines in 2005 that focused on the nonclinical (S7B) and clinical (E14) assessment of surrogate biomarkers for TdP. Recently, Varg...

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Detalles Bibliográficos
Autores principales: Strauss, David G., Wu, Wendy W., Li, Zhihua, Koerner, John, Garnett, Christine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898549/
https://www.ncbi.nlm.nih.gov/pubmed/33332579
http://dx.doi.org/10.1002/cpt.2137

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898549/
https://www.ncbi.nlm.nih.gov/pubmed/33332579
http://dx.doi.org/10.1002/cpt.2137

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