Comprehensive in vitro Proarrhythmia Assay (CiPA): Pending issues for successful validation and implementation
Icilio Cavero1, Jean-Michel Guillon2, Veronique Ballet2
154 Rue de la Glacière, 75013 Paris, France.
Journal of Pharmacological and Toxicological Methods
|May 29, 2016
Summary
The Comprehensive in vitro Proarrhythmia Assay (CiPA) advances drug safety by examining electrophysiological mechanisms. Addressing key assay components is crucial for its regulatory implementation in drug development.
Area of Science:
- Pharmacology
- Cardiology
- Drug Safety
Background:
- The Comprehensive in vitro Proarrhythmia Assay (CiPA) is a safety pharmacology paradigm.
- It aims to identify electrophysiological mechanisms conferring proarrhythmic liability in drug candidates.
Purpose of the Study:
- To summarize key discussions from the 'CiPA on my mind' session at the 2015 Safety Pharmacology Society (SPS) Annual Meeting.
- To critically examine issues and solutions for CiPA core assay constituents.
Main Methods:
- Review of talks presented at the 2015 SPS Annual Meeting.
- Critical examination of biological materials (ion channels, stem cell-derived cardiomyocytes), study platforms, drug solutions, and data analysis.
Main Results:
- Identified key challenges and potential solutions for CiPA assay components.
- Highlighted the importance of robust and reproducible results for regulatory acceptance.
Conclusions:
- Systematic guidance from stakeholders is needed to advance CiPA to a regulatory strategy.
- Qualified regulatory procedures require proven robust and reproducible study protocols.
Keywords:
Comprehensive in vitro Proarrhythmia Assay (CiPA)Field potential data sampling and analysisInduced pluripotent cell cardiomyocytes (hiPSC-CMs)Multi electrode array (MEA)Patch clamp technologiesPending issues and solutionsValidationVoltage sensitive dye (VSD)More Related Videos
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