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ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies
The International Conference on Harmonization (ICH) E14 document was revised in 2015 to allow concentration–corrected QT interval (C–QTc) analysis to be applied to data from early clinical pharmacology studies to exclude a small drug‐induced effect on QTc. Provided sufficiently high concentrations o...
Autores principales: | Darpo, Borje, Borin, Marie, Ferber, Georg, Galluppi, Gerald R., Hopkins, Seth C., Landry, Ishani, Lo, Arthur, Rege, Bhaskar, Reyderman, Larisa, Sun, Lei, Watanabe, Takao, Xue, Hongqi, Yasuda, Sally |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9796926/ https://www.ncbi.nlm.nih.gov/pubmed/35665514 http://dx.doi.org/10.1002/jcph.2095 |
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