- 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...
Expand abstract - Publication status:
- Published
- Peer review status:
- Peer reviewed
- Version:
- Publisher's Version
- 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:
- Copyright holder:
- Li et al.
- Copyright date:
- 2019
- Notes:
- © 2019 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Journal article
General principles for the validation of proarrhythmia risk prediction models: an extension of the CiPA in silico strategy
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