Comprehensive in vitro Proarrhythmia Assay CiPA: Pending issues for successful validation and implementationReport as inadecuate

Comprehensive in vitro Proarrhythmia Assay CiPA: Pending issues for successful validation and implementation - Download this document for free, or read online. Document in PDF available to download.

1 Chercheur Indépendant 2 Sanofi Vitry-sur-Seine 3 GE Healthcare - General Electric Healthcare Cardiff 4 REO - Numerical simulation of biological flows LJLL - Laboratoire Jacques-Louis Lions, UPMC - Université Pierre et Marie Curie - Paris 6, Inria de Paris

Abstract : Introduction: The Comprehensive in vitro Proarrhythmia Assay CiPA is a nonclinical Safety Pharmacology paradigm for discovering electrophysiological mechanisms that are likely to confer proarrhythmic liability to drug candidates intended for human use.Topics covered: Key talks delivered at the ‘CiPA on my mind’ session, held during the 2015 Annual Meeting of the Safety Pharmacology Society SPS, are summarized. Issues and potential solutions relating to crucial constituents e.g., biological materials ion channels and pluripotent stem cell-derived cardiomyocytes, study platforms, drug solutions, and data analysis of CiPA core assays are critically examined.Discussion: 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 : Pending issues and solution Patch clamp technologies Multi electrode array MEA Induced pluripotent cell cardiomyocytes hiPSC-CMs Field potential data sampling and analysis Validation Voltage sensitive dye VSD Comprehensive in vitro Proarrhythmia Assay CiPA

Author: Icilio Cavero - Jean-Michel Guillon - Veronique Ballet - Mike Clements - Jean-Frédéric Gerbeau - Henry Holzgrefe -



Related documents