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Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity
The most recent International Conference on Harmonisation E14 Q&A document states that a separate positive control would not be necessary provided sufficiently high exposures are achieved in the early‐phase studies. Realistically, a phase 1 study is unlikely to include a pharmacological positive...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5763401/ https://www.ncbi.nlm.nih.gov/pubmed/28833240 http://dx.doi.org/10.1002/jcph.975 |