| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5556595 | Journal of Pharmacological and Toxicological Methods | 2016 | 16 Pages |
Abstract
In order to advance the CiPA paradigm from the current testing and validation stages to a research and regulatory drug development strategy, systematic guidance by CiPA stakeholders is necessary to expedite solutions to pending and newly arising issues. Once a study protocol is proved to yield robust and reproducible results within and across laboratories, it can be implemented as qualified regulatory procedure.
Keywords
GLPIKSVmaxFPDVSDLQTSTDPQTcCrosIKrThorough QT studyMEAICaLIK1ILSIIhERGCIPAQMSTQTLQThiPSC-CMshpfLPFHTSSPSCAVCDIDMSODNAMulti-electrode arraysGood Laboratory PracticesComprehensive in vitro Proarrhythmia AssayISIdeoxyribonucleic acidValidationstandard deviationCSAITOslowly activating delayed rectifier potassium currentclustered regularly interspaced short palindromic repeatsCRISPrapidly activating delayed rectifier potassium currentTransient outward potassium currentInward rectifier potassium currentstandard error of the meanDimethyl sulfoxidevoltage-sensitive dyesLong QT syndromeQuality management systemhigh throughput screeninginterspike intervalHigh pass filterLow pass filteraction potential duration at 90% repolarizationfield potential durationSEMICHInternational Life Sciences InstituteHealth and Environmental Sciences InstituteNavHESIaction potentialField potentialVoltage-dependent sodium channelVoltage-dependent calcium channelInternational Conference on HarmonizationWorking group
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Pharmacology
Authors
Icilio Cavero, Jean-Michel Guillon, Veronique Ballet, Mike Clements, Jean-Frédéric Gerbeau, Henry Holzgrefe,