A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm.

"the unblinded drug names and concentrations along with the measured block percentage for each cell are available along with this publication at https://github com/fda/cipa/tree/ systematic_strategy_herg_block_2020."

"Declaration of Competing Interest The authors declared no conflict of interests."

"The authors thank Dr. Khuram Chaudhary and Dr. Liang Guo for preparing the drug and dilution protocols for distribution to the sites. The authors also thank Dr. Kylie Beattie for exploratory data analysis on this project. Additionally, the authors would like to thank all further volunteers from the different sites for their participation and contributions to this study. Dr. Gary Mirams was funded by a Senior Research Fellowship from the Wellcome Trust [grant number 212202/Z/18/Z]. Dr. Remi Bardenet acknowledges support from ANR grant BoB (ANR-16-CE23-0003). This work is supported by the Research Participation Program at the Center for Drug Evaluation and Research, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the US Department of Energy and the US Food and Drug Administration."