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2021
Strauss, D.G., Wu, W.W., Li, Z., Koerner, J. and Garnett, C. (2021), Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates). Clin. Pharmacol. Ther., 109: 319-333. https://doi.org/10.1002/cpt.2137
2020
Xiaomei Han, Mohammadreza Samieegohar, Bradley J. Ridder, Wendy W. Wu, Aaron Randolph, Phu Tran, Jiansong Sheng, Sonja Stoelzle-Feix, Nina Brinkwirth, Maria Giustina Rotordam, Nadine Becker, Søren Friis, Markus Rapedius, Tom A. Goetze, Tim Strassmaier, George Okeyo, James Kramer, Yuri Kuryshev, Caiyun Wu, David G. Strauss, Zhihua Li, (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. Journal of Pharmacological and Toxicological Methods, 105: 1056-8719. https://doi.org/10.1016/j.vascn.2020.106890.
Gary Gintant, Emily Pfeiffer Kaushik, Tromondae Feaster, Sonja Stoelzle-Feix, Yasunari Kanda, Tomoharu Osada, Godfrey Smith, Katherine Czysz, Ralf Kettenhofen, Hua Rong Lu, Beibei Cai, Hong Shi, Todd Joseph Herron, Qianyu Dang, Francis Burton, Li Pang, Martin Traebert, Yama Abassi, Jennifer Beck Pierson, Ksenia Blinova, Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations, Regulatory Toxicology and Pharmacology, 117, https://doi.org/10.1016/j.yrtph.2020.104756.
Ridder BJ, Leishman DJ, Bridgland-Taylor M, Samieegohar M, Han X, Wu WW, Randolph A, Tran P, Sheng J, Danker T, Lindqvist A, Konrad D, Hebeisen S, Polonchuk L, Gissinger E, Renganathan M, Koci B, Wei H, Fan J, Levesque P, Kwagh J, Imredy J, Zhai J, Rogers M, Humphries E, Kirby R, Stoelzle-Feix S, Brinkwirth N, Giustina Rotordam M, Becker N, Friis S, Rapedius M, Goetze TA, Strassmaier T, Okeyo G, Kramer J, Kuryshev Y, Wu C, Himmel H, Mirams GR, Strauss DG, Bardenet R, Li Z (2020.) A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm, Toxicology and Applied Pharmacology, doi: 10.1016/j.taap.2020.114961.
Kramer J, Himmel HM, Lindqvist A, Stoelzle-Feix S, Chaudhary KW, Li D, Bohme GA, Bridgland-Taylor M, Hebeisen S, Fan J, Renganathan M, Imredy J, Humphries ESA, Brinkwirth N, Strassmaier T, Ohtsuki A, Danker T, Vanoye C, Polonchuk L, Fermini B, Pierson JB & Gintant G (2020.) Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells. Sci Rep 10, 5627 (2020). https://doi.org/10.1038/s41598-020-62344-w
2019
Li Z, Mirams GR, Yoshinaga T, Ridder BJ, Han X, Chen JE, Stockbridge NL, Wisialowski TA, Damiano B, Severi S, Morissette P, Kowey PR, Holbrook M, Smith G, Rasmusson RL, Liu M, Song Z, Qu Z, Leishman DJ, Steidl‐Nichols J, Rodriguez B, Bueno‐Orovio A, Zhou X, Passini E, Edwards AG, Morotti S, Ni H, Grandi E, Clancy CE, Vandenberg J, Hill A, Nakamura M, Singer T, Polonchuk L, Greiter‐Wilke A, Wang K, Nave S, Fullerton A, Sobie EA, Paci M, Tshinanu FM, Strauss DG (2019.) General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy. Clinical Pharmacology and Therapeutics. https://doi.org/10.1002/cpt.1647
Park JS, Jeon JY, Yang JH, Kim MG (2019.) Introduction to in silico model for proarrhythmic risk assessment under the CiPA initiative. Transl Clin Pharmacol, 27(1):12-18. doi: 10.12793%2Ftcp.2019.27.1.12.
Pfeiffer-Kaushik ER, Smith GL, Cai B, et al. Electrophysiological characterization of drug response in hSC-derived cardiomyocytes using voltage-sensitive optical platforms. J Pharmacol Toxicol Methods. 2019;99:106612. doi:10.1016/j.vascn.2019.106612
2018
Vicente J, Zusterzeel R, Johannesen L, Ochoa-Jimenez R, Mason JW, Sanabria C, Kemp S, Sager PT, Patel V, Matta MK, Liu J, Florian J, Garnett C, Stockbridge N, Strauss DG. (2018.) Assessment of Multi-Ion Channel Block in a Phase-1 Randomized Study Design: Results of the CiPA Phase 1 ECG Biomarker Validation Study. Clin Pharmacol Ther. 2018 Nov 17. doi: 10.1002/cpt.1303. Read the full PDF.
Blinova K., Dang Q., Millard D., Smith G., Pierson J., Liang G., Brock M., Lu H.R., Kraushaar U., Zeng H., Shi H., Zhang X., Sawada K., Osada T., Kanda Y., Sekino Y., Pang L., Feaster T.K., Kettenhofen R., Stockbridge N., Strauss D.G., Gintant G. (2018). (2018). International Multisite Study of Human Induced Pluripotent Stem Cell Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment. Cell Reports. Available online September 25, 2018. https://doi.org/10.1016/j.celrep.2018.08.079.
David G. Strauss, MD, PhD, Gary Gintant, PhD, Zhihua Li, PhD, Wendy Wu, PhD, Ksenia Blinova, PhD, Jose Vicente, PhD, J. Rick Turner, PhD, DSc, and Philip T. Sager, MD (2018.) Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. Therapeutic Innovation & Regulatory Science. Available here First Published August 29, 2018. doi.org/10.1177/2168479018795117
Li, Z. , Ridder, B. J., Han, X. , Wu, W. W., Sheng, J. , Tran, P. N., Wu, M. , Randolph, A. , Johnstone, R. H., Mirams, G. R., Kuryshev, Y. , Kramer, J. , Wu, C. , Crumb, W. J. and Strauss, D. G. (2018). Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative. Clin. Pharmacol. Ther. Available online August 27, 2018. doi:10.1002/cpt.1184
Daniel Millard, Qianyu Dang, Hong Shi, Xiaou Zhang, Chris Strock, Udo Kraushaar, Haoyu Zeng, Paul Levesque, Hua-Rong Lu, Jean-Michel Guillon, Joseph C Wu, Yingxin Li, Greg Luerman, Blake Anson, Liang Guo, Mike Clements, Yama A Abassi, James Ross, Jennifer Pierson, Gary Gintant. (2018) Cross-Site Reliability of Human Induced Pluripotent Stem-Cell Derived Cardiomyocyte Based Safety Assays using Microelectrode Arrays: Results from a Blinded CiPA Pilot Study, Toxicological Sciences, Online ahead of print, https://doi.org/10.1093/toxsci/kfy110
Corina T.Bot, Krisztina Juhasz, Fabian Haeusermann,Liudmila Polonchuk, Martin Traebert, Sonja Stoelzle-Feix (2018.) Cross - site comparison of excitation-contraction coupling using impedance and field potential recordings in hiPSC cardiomyocytes
Author links open overlay panel. Journal of Pharmacological and Toxicological Methods. Available online 22 June 2018. doi: 10.1016/j.vascn.2018.06.006
J Vicente, R Zusterzeel, L Johannesen, J Mason, P Sager, V Patel, MK Matta, Z Li, J Liu, C Garnett, N Stockbridge, I Zineh, DG Strauss (2018.) Mechanistic Model‐Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study. Clinical Pharmacology & Therapeutics, 103 (1); 54-66. https://doi.org/10.1002/cpt.896
2017
Ando H, Yoshinaha T, Yamamoto W, Asakura K, Uda T, Taniguchi T, Ojima A, Shinkyo R, Kikuchi K, Osada T, Hayashi S, Kasai C, Miyamoto H, Yamazaki D, Sugiyama A, Kanda Y, Sawada K, Sekino Y. (2017) A new paradigm for drug-induced torsadogenic risk assessment using human iPS cell-derived cardiomyocytes. Journal of Pharmacological and Toxicological Methods 84: 111-127. doi: 0.1016/j.vascn.2016.12.003. Available here.
Chang KC, Dutta S, Mirams GR, Beattie KA, Sheng J, Tran PN, Wu M, Wu WW, Colatsky T, Strauss DG, Li Z (2017) Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment. Front. Physiol., 21 November 2017. https://doi.org/10.3389/fphys.2017.00917. Available here.
Dutta S, Chang KC, Beattie KA, Sheng J, Tran PN, Wu WW, Wu M, Strauss DG, Colatsky T, Li Z. (2017). Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment. Front. Physiol., 23 August 2017 doi:10.3389/fphys.2017.00616. Available here.
Li Z, Dutta S, Sheng J, Tran PN, Wu W, Chang K, Mdluli T, Strauss DG, Colatsky T. (2017) Improving the In Silico Assessment of Proarrhythmia Risk by Combining hERG (Human Ether-à-go-go-Related Gene) Channel–Drug Binding Kinetics and Multichannel Pharmacology. Circulation: Arrhythmia and Electrophysiology. 2017;10:e004628. doi: 10.1161/CIRCEP.116.004628. Available here.
2016
Blinova, K., Stohlman, J., Vicente, J., Chan, D., Johannesen, L., Hortigon-Vinagre, MP., Zamora, V., Smith, G., Crumb, WJ., Pang, L., Lyn-Cook, B., Ross, J., Brock, B., Chvatal, S., Millard, D., Galeotti, D., Stockbridge, D., Strauss, DG. (2016) Comprehensive Translational Assessment of Human Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias. Toxicological Sciences. doi: 10.1093/toxsci/kfw200. Available here.
Colatsky, T., Fermini, B., Gintant, G., Pierson, J., Sager, P., Sekino, Y., Strauss, D., Stockbridge, N. (2016) The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative — Update on progress. Journal of Pharmacological and Toxicological Methods. 81:15-20. doi: 10.1016/j.vascn.2016.06.002. Open access download here.
Crumb, WJ., Vicente, J., Johannesen, L., Strauss, DG. (2016) An evaluation of 30 clinical drugs against the comprehensive in vitro proarrhythmia assay (CiPA) proposed ion channel panel. Journal of Pharmacological and Toxicological Methods. In press. Preprint available here. Supplement available here.
Dutta, S., Strauss, D, Colatsky, T. Li, Z. (2016) Optimization of an In Silico Cardiac Cell Model for Proarrhythmia Risk Assessment. Computing in Cardiology. 43; doi:10.22489/CinC.2016.253-483. Available here.
Gintant, G., Sager, PT., Stockbridge, N. (2016). Evolution of strategies to improve preclinical cardiac safety testing. Nature Reviews Drug Discovery. 15: 457. Available here.
Johannesen, L., Vicente, J., Hosseini, M., Strauss, D.G. (2016) Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk. PLOS ONE, available online December 30, 2016, DOI:10.1371/journal.pone.0166925. Available here.
Li, Z., Dutta, S., Sheng, J., Tran, PN., Wu, W., Cotalsky, T. (2016) A temperature-dependent in silico model of the human ether-à-go-go-related (hERG) gene channel. Journal of Pharmacological and Toxicological Methods. 81, 233-239. doi: 10.1016/j.vascn.2016.05.005. Available here.
Vicente, J., Johannesen, L., Hosseini, M., Mason, J.W., Sager, P.T., Pueyo, E., Strauss, D.G. (2016) Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block. PLOS ONE, available online December 30, 2016, DOI: 10.1371/journal.pone.0163619. Available here.
Yamamoto W, Asakura K, Ando H, Taniguchi T, Ojima A, Uda T, Osada T, Hayashi S, Kasai C, Miyamoto N, Tashibu H, Yoshinaha T, Yamazaki D, Sugiyama A, Kanda Y, Sawada K, Sekino Y. (2016) Electrophysiological Characteristics of Human
iPSC-Derived Cardiomyocytes for the Assessment of Drug-Induced Proarrhythmic Potential. PLoS ONE 11(12): e0167348. doi:10.1371/journal. pone.0167348. Available here.
2015
Fermini B, Hancox JC, Abi-Gerges N, Bridgland-Taylor M, Chaudhary KW, Colatsky T, Correll K, Crumb W, Damiano B, Erdemli G, Gintant G, Imredy J, Koerner J, Kramer J, Levesque P, Li Z, Lindqvist A, Obejero-Paz CA, Rampe D, Sawada K, Strauss DG, Vandenberg JI. (2015) A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm. J Biomol Screen. 21(1):1-11. doi: 10.1177/1087057115594589. Available here.
Johannesen, L., Vicente, J., Mason, JW., Erato, C., Sanabria, C., Waite-Labott, K., Hong, M., Lin, J., Guo, P., Mutlib, A., Wang, J., Crumb, WJ., Blinova, K., Chan, D., Stohlman, J., Florian, J., Ugander, M., Stockbridge, N., Strauss, DG. (2015) Late Sodium Current Block for Drug-Induced Long QT Syndrome: Results From a Prospective Clinical Trial. Clinical Pharmacology and Therapeutics. 99; 2. Available here.
Vicente, J., Johannesen, L., Mason, JW., Crumb, WJ., Pueyo, E., Stockbridge, N., Strauss, DG. (2015) Comprehensive T wave Morphology Assessment in a Randomized Clinical Study of Dofetilide, Quinidine, Ranolazine, and Verapamil. Journal of the American Heart Association. doi: 10.1161/JAHA.114.001615. Available here.
2014
Johannesen, L., Vicente, J., Mason, JW., Sanabria, C., Waite-Labott, K., Hong, M., Guo, P., Lin, J., Sorensen, JS., Galeotti, L., Florian, J., Ugander, M., Stockbridge, N., Strauss, DG. (2014) Differentiating Drug-Induced Multichannel Block on the Electrocardiogram: Randomized Study of Dofetilide, Quinidine, Ranolazine, and Verapamil. Clinical pharmacology & Therapeutics. 96, 549-558. doi: 10.1038/clpt.2014.155. Available here.
Sager, P.T., Gintant, G., Turner, J.R., Pettit, S., Stockbridge, N. (2014) Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium. American Heart Journal. 167:3, 292-300. Open Access download here.
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