Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium.
Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Department of Integrative Pharmacology, AbbVie, North Chicago, IL, USA.
HESI, Washington, DC, USA.
Drug Safety and Metabolism, AstraZeneca, Macclesfield, Cheshire, UK.
Drug Safety Research and Development, Pfizer, Groton, CT, USA.
Non-Clinical Development, UCB-Biopharma SPRL, Braine-l'Alleud, Belgium.
- Published Article
British Journal of Pharmacology
Wiley (Blackwell Publishing)
- Publication Date
Feb 01, 2018
The predictive value of hERG, APD and QTc assays varies, with drug concentrations strongly affecting translational performance. While useful in guiding preclinical candidates without clinical QT prolongation, hERG and QTc repolarization assays provide greater value compared with the APD assay.
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This record was last updated on 06/09/2018 and may not reflect the most current and accurate biomedical/scientific data available from NLM.
The corresponding record at NLM can be accessed at https://www.ncbi.nlm.nih.gov/pubmed/29181850