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Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium.

Authors
  • Park, Eunjung1
  • Gintant, Gary A2
  • Bi, Daoqin1
  • Kozeli, Devi1
  • Pettit, Syril D3
  • Pierson, Jennifer B3
  • Skinner, Matthew4
  • Willard, James1
  • Wisialowski, Todd5
  • Koerner, John1
  • Valentin, Jean-Pierre6
  • 1 Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
  • 2 Department of Integrative Pharmacology, AbbVie, North Chicago, IL, USA.
  • 3 HESI, Washington, DC, USA.
  • 4 Drug Safety and Metabolism, AstraZeneca, Macclesfield, Cheshire, UK.
  • 5 Drug Safety Research and Development, Pfizer, Groton, CT, USA.
  • 6 Non-Clinical Development, UCB-Biopharma SPRL, Braine-l'Alleud, Belgium. , (Belgium)
Type
Published Article
Journal
British Journal of Pharmacology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Feb 01, 2018
Volume
175
Issue
4
Pages
606–617
Identifiers
DOI: 10.1111/bph.14101
PMID: 29181850
Source
Medline
License
Unknown

Abstract

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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