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General principles for the validation of proarrhythmia risk prediction models: an extension of the CiPA in silico strategy

Abstract:

This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration–sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding...

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Publication status:
Published
Peer review status:
Peer reviewed
Version:
Publisher's Version

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Publisher copy:
10.1002/cpt.1647

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Publisher:
American Society for Clinical Pharmacology and Therapeutics Publisher's website
Journal:
Clinical Pharmacology and Therapeutics Journal website
Volume:
107
Issue:
1
Pages:
102-111
Publication date:
2019-11-10
Acceptance date:
2019-09-06
DOI:
ISSN:
0009-9236 and 1532-6535
Pubs id:
pubs:1070888
URN:
uri:63db076d-104f-43df-899e-924d5817e220
UUID:
uuid:63db076d-104f-43df-899e-924d5817e220
Local pid:
pubs:1070888
Language:
English
Keywords:

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