Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective

Defining an appropriate and efficient assessment of drug‐induced corrected QT interval (QTc) prolongation (a surrogate marker of torsades de pointes arrhythmia) remains a concern of drug developers and regulators worldwide. In use for over 15 years, the nonclinical International Council for Harmoniz...

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Detalles Bibliográficos
Autores principales: Vargas, Hugo M., Rolf, Michael G., Wisialowski, Todd A., Achanzar, William, Bahinski, Anthony, Bass, Alan, Benson, Charles T, Chaudhary, Khuram W., Couvreur, Nicolas, Dota, Corina, Engwall, Michael J, Michael Foley, C., Gallacher, David, Greiter‐Wilke, Andrea, Guillon, Jean‐Michel, Guth, Brian, Himmel, Herbert M., Hegele‐Hartung, Christa, Ito, Maki, Jenkinson, Stephen, Chiba, Katsuyoshi, Lagrutta, Armando, Levesque, Paul, Martel, Eric, Okai, Yoshiko, Peri, Ravikumar, Pointon, Amy, Qu, Yusheng, Teisman, Ard, Traebert, Martin, Yoshinaga, Takashi, Gintant, Gary A., Leishman, Derek J., Valentin, Jean‐Pierre
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7891594/
https://www.ncbi.nlm.nih.gov/pubmed/32866317
http://dx.doi.org/10.1002/cpt.2029

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