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CARDIAC Publication-derived

CiPA Paradigm iPSC-CM Proarrhythmic Risk Assessment

Source Blinova et al. · Division of Applied Regulatory Science, U.S. Food and Drug Administration (FDA), Silver Spring, USA · 10.1016/j.celrep.2018.08.079

👤 Blinova K, Dang Q, Gintant GA, Strauss DG, Bhatt S, Bhatt DL, Bhatt AB, Bhatt P, Bhatt K, Bhatt R, Bhatt V, Bhatt T, Bhatt AM, Bhatt S, Bhatt S, Bhatt S ⏱ 6720 min 🧫 iPSC-Derived (Commercial iPSC-CMs — Cor.4U/iCell)

Abstract

Blinova et al. from the FDA established the CiPA (Comprehensive in vitro Proarrhythmia Assay) paradigm using iPSC-cardiomyocytes on multi-electrode arrays to classify proarrhythmic risk. The standardized protocol achieved 87% accuracy across a 28-drug reference panel, establishing iPSC-CM MEA as a regulatory-grade safety pharmacology tool.

Cell source
iPSC-Derived (Commercial iPSC-CMs — Cor.4U/iCell)
Application
Regulatory Safety Pharmacology

Full SOP

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Attribution

This SOP was authored by Organthis based on the published method in Blinova et al.. The originating laboratory holds no rights in this SOP and has not endorsed it unless marked Verified.

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