2020 - A general procedure to select calibration drugs for lab-specific validation and calibration of proarrhythmia risk prediction models: An illustrative example using the CiPA model
SyncroPatch 768PE (a predecessor model of the SyncroPatch 768i instrument) publication in the Journal of Pharmacological and Toxicological Methods (2020)
Han X., Samieegohar M., Ridder B.J., Wu W.W., Randolph A., Tran P., Sheng J., Stoelzle-Feiz S., Brinkwirth N., Rotordam M.G., Becker N., Friis S., Rapedius M., Goteze T.A., Strassmaier T., Okeyo G., Kramer J., Kuryshev Y., Li Z.
Journal of Pharmacological and Toxicological Methods (2020) doi: 10.1016/j.vascn.2020.106890
In response to the ongoing shift of the regulatory cardiac safety paradigm, a recent White Paper proposed general principles for developing and implementing proarrhythmia risk prediction models. These principles included development strategies to validate models, and implementation strategies to ensure a model developed by one lab can be used by other labs in a consistent manner in the presence of lab-to-lab experimental variability. While the development strategies were illustrated through the validation of the model under the Comprehensive In vitro Proarrhythmia Assay (CiPA), the implementation strategies have not been adopted yet.