Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting.
Ther Innov Regul Sci
; 53(4): 519-525, 2019 07.
Article
em En
| MEDLINE
| ID: mdl-30157676
ABSTRACT
A Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA-sponsored Think Tank Meeting was convened in Washington, DC, on May 21, 2018, to bring together scientists, clinicians, and regulators from multiple geographic regions to evaluate progress to date in the Comprehensive In Vitro Proarrhythmia Assay (CiPA) Initiative, a new paradigm to evaluate proarrhythmic risk. Study reports from the 4 different components of the CiPA paradigm (ionic current studies, in silico modeling to generate a Torsade Metric Score, human induced pluripotent stem cell-derived ventricular cardiomyocytes, and clinical ECG assessments including J-Tpeakc) were presented and discussed. This paper provides a high-level summary of the CiPA data presented at the meeting.
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MEDLINE
Assunto principal:
Arritmias Cardíacas
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Avaliação Pré-Clínica de Medicamentos
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article