Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

Author:

Strauss David G.ORCID,Gintant Gary,Li Zhihua,Wu Wendy,Blinova Ksenia,Vicente JoseORCID,Turner J. Rick,Sager Philip T.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference18 articles.

1. Sager PT, Gintant G, Turner JR, Pettit S, Stockbridge N. Rechanneling the cardiac proarrhythmia safety paradigm: a meeting report from the Cardiac Safety Research Consortium. Am Heart J. 2014;167:292–300.

2. CiPA Update Workshop: an CSRC-HESI-SPS-FDA Meeting. http://www.cardiac-safety.org/think-tanks-meetings/2014-meetings/cipa-update-workshop-csrc-hesi-sps-fda-meeting/. Published December 2014. Accessed June 29, 2018.

3. CSRS/FDA Workshop: the proarrhythmic assessment of new chemical entities (with a focus on Phase I ECGs). April 2016. http://www.cardiac-safety.org/2016/04/csrcfda-workshop-the-proarrhythmic-assessment-of-new-chemical-entities/. Accessed June 29, 2018.

4. CSRC. Critical discussion: future of the assessment of drug-induced arrhythmias and the Comprehensive in Vitro Proarrhythmia Assay (CiPA). http://www.cardiac-safety.org/2016/12/critical-discussion-future-of-the-assessment-of-drug-induced-arrhythmias-and-the-comprehensive-in-vitro-proarrhythmia-assay-cipa/. Published December 2016. Accessed June 29, 2018.

5. FDA. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, March 2017. https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm535520.htm. Accessed June 29, 2018.

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