Li, Zhihua and Mirams, Gary R. and Yoshinaga, Takashi and Ridder, Bradley J. and Han, Xiaomei and Chen, Janell E. and Stockbridge, Norman L. and Wisialowski, Todd A. and Damiano, Bruce and Severi, Stefano and Morissette, Pierre and Kowey, Peter R. and Holbrook, Mark and Smith, Godfrey and Rasmusson, Randall L. and Liu, Michael and Song, Zhen and Qu, Zhilin and Leishman, Derek J. and Steidl‐Nichols, Jill and Rodriguez, Blanca and Bueno‐Orovio, Alfonso and Zhou, Xin and Passini, Elisa and Edwards, Andrew G. and Morotti, Stefano and Ni, Haibo and Grandi, Eleonora and Clancy, Colleen E. and Vandenberg, Jamie and Hill, Adam and Nakamura, Mikiko and Singer, Thomas and Polonchuk, Liudmila and Greiter‐Wilke, Andrea and Wang, Ken and Nave, Stephane and Fullerton, Aaron and Sobie, Eric A. and Paci, Michelangelo and Musuamba Tshinanu, Flora and Strauss, David G. (2020) General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy. Clinical Pharmacology & Therapeutics, 107. pp.102-111. ISSN 0009-9236
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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 these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model-based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia assessment. This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.
| Item Type: | Article |
|---|---|
| Subjects: | R Medicine > R Medicine (General) |
| Depositing User: | Repository Administrator |
| Date Deposited: | 19 Nov 2019 22:58 |
| Last Modified: | 15 Oct 2021 00:40 |
| URI: | https://eprints.victorchang.edu.au/id/eprint/876 |
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