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Items: 1 to 20 of 115


International Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment.

Blinova K, Dang Q, Millard D, Smith G, Pierson J, Guo L, Brock M, Lu HR, Kraushaar U, Zeng H, Shi H, Zhang X, Sawada K, Osada T, Kanda Y, Sekino Y, Pang L, Feaster TK, Kettenhofen R, Stockbridge N, Strauss DG, Gintant G.

Cell Rep. 2018 Sep 25;24(13):3582-3592. doi: 10.1016/j.celrep.2018.08.079.


Trends and Outcomes of Catheter Ablation for Ventricular Tachycardia in a Community Cohort.

Yousuf OK, Zusterzeel R, Sanders W, Caños D, Dekmezian C, Silverman H, Calkins H, Berger R, Tandri H, Nazarian S, Strauss DG.

JACC Clin Electrophysiol. 2018 Sep;4(9):1189-1199. doi: 10.1016/j.jacep.2018.06.020. Epub 2018 Aug 29.


The ability of the electrocardiogram in left bundle branch block to detect myocardial scar determined by cardiovascular magnetic resonance.

Wieslander B, Xia X, Jablonowski R, Axelsson J, Klem I, Nijveldt R, Maynard C, Schelbert EB, Sörensson P, Sigfridsson A, Chaudhry U, Platonov PG, Borgquist R, Engblom H, Couderc JP, Strauss DG, Atwater BD, Ugander M.

J Electrocardiol. 2018 Sep - Oct;51(5):779-786. doi: 10.1016/j.jelectrocard.2018.05.019. Epub 2018 May 30.


Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting.

Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, Turner JR, Sager PT.

Ther Innov Regul Sci. 2018 Aug 29:2168479018795117. doi: 10.1177/2168479018795117. [Epub ahead of print]


Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative.

Li Z, Ridder BJ, Han X, Wu WW, Sheng J, Tran PN, Wu M, Randolph A, Johnstone RH, Mirams GR, Kuryshev Y, Kramer J, Wu C, Crumb WJ Jr, Strauss DG.

Clin Pharmacol Ther. 2018 Aug 27. doi: 10.1002/cpt.1184. [Epub ahead of print]


FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".

Akbar M, Berry-Bibee E, Blithe DL, Day RS, Edelman A, Höchel J, Jamshidi R, Kim MJ, Li L, Purohit VS, Turpin JA, Scott PE, Strauss DG, Sun H, Tepper NK, Zhang L, Yu C.

J Clin Pharmacol. 2018 Aug 24. doi: 10.1002/jcph.1285. [Epub ahead of print]


The 43rd International Society for Computerized Electrocardiology ECG initiative for the automated detection of strict left bundle branch block.

Zusterzeel R, Vicente J, Ochoa-Jimenez R, Zhu J, Couderc JP, Akinnagbe-Zusterzeel E, Strauss DG.

J Electrocardiol. 2018 Aug 1. pii: S0022-0736(18)30351-0. doi: 10.1016/j.jelectrocard.2018.08.001. [Epub ahead of print]


CiPA challenges and opportunities from a non-clinical, clinical and regulatory perspectives. An overview of the safety pharmacology scientific discussion.

Wallis R, Benson C, Darpo B, Gintant G, Kanda Y, Prasad K, Strauss DG, Valentin JP.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:15-25. doi: 10.1016/j.vascn.2018.06.005. Epub 2018 Jun 27. Review.


Multivariate physiological recordings in an experimental hemorrhage model.

Yaghouby F, Daluwatte C, Marques NR, Khan M, Salter M, Wolf J, Nelson C, Salsbury J, Enkhbaatar P, Kinsky M, Strauss DG, Kramer GC, Scully CG.

Data Brief. 2018 Jan 31;17:544-550. doi: 10.1016/j.dib.2018.01.053. eCollection 2018 Apr.


Correction: Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block.

Vicente J, Johannesen L, Hosseini M, Mason JW, Sager PT, Pueyo E, Strauss DG.

PLoS One. 2018 May 21;13(5):e0197952. doi: 10.1371/journal.pone.0197952. eCollection 2018.


Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: FDA Patient-Level Meta-Analysis of Premarket Clinical Trials.

Zusterzeel R, Mishra NK, Beydoun H, Laschinger J, Wu C, Dong LM, Lin JA, Marinac-Dabic D, Strauss DG, Caños DA.

J Womens Health (Larchmt). 2018 Jun;27(6):808-814. doi: 10.1089/jwh.2017.6760. Epub 2018 May 9.


Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.

Rouse R, Kruhlak N, Weaver J, Burkhart K, Patel V, Strauss DG.

Ther Innov Regul Sci. 2018 Mar;52(2):244-255. doi: 10.1177/2168479017720249. Epub 2017 Jul 21.


Regulatory Science - An Underappreciated Component of Translational Research.

Rouse R, Zineh I, Strauss DG.

Trends Pharmacol Sci. 2018 Mar;39(3):225-229. doi: 10.1016/ Epub 2018 Jan 9.


Corrigendum: Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment.

Dutta S, Chang KC, Beattie KA, Sheng J, Tran PN, Wu WW, Wu M, Strauss DG, Colatsky T, Li Z.

Front Physiol. 2017 Dec 6;8:1025. doi: 10.3389/fphys.2017.01025. eCollection 2017.


Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment.

Chang KC, Dutta S, Mirams GR, Beattie KA, Sheng J, Tran PN, Wu M, Wu WW, Colatsky T, Strauss DG, Li Z.

Front Physiol. 2017 Nov 21;8:917. doi: 10.3389/fphys.2017.00917. eCollection 2017.


Comparative analysis of media effects on human induced pluripotent stem cell-derived cardiomyocytes in proarrhythmia risk assessment.

Schocken D, Stohlman J, Vicente J, Chan D, Patel D, Matta MK, Patel V, Brock M, Millard D, Ross J, Strauss DG, Blinova K.

J Pharmacol Toxicol Methods. 2018 Mar - Apr;90:39-47. doi: 10.1016/j.vascn.2017.11.002. Epub 2017 Nov 16.


Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: A Review of the Literature.

Azarbaijani Y, O'Callaghan K, Sanders WE, Wu C, Laschinger J, Marinac-Dabic D, Strauss DG, Canos DA, Zusterzeel R.

Cardiol Rev. 2018 Mar/Apr;26(2):73-81. doi: 10.1097/CRD.0000000000000177. Review.


Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.

Vicente J, Zusterzeel R, Johannesen L, Mason J, Sager P, Patel V, Matta MK, Li Z, Liu J, Garnett C, Stockbridge N, Zineh I, Strauss DG.

Clin Pharmacol Ther. 2018 Jan;103(1):54-66. doi: 10.1002/cpt.896. Epub 2017 Nov 16. Review.


A novel ECG detector performance metric and its relationship with missing and false heart rate limit alarms.

Daluwatte C, Vicente J, Galeotti L, Johannesen L, Strauss DG, Scully CG.

J Electrocardiol. 2018 Jan - Feb;51(1):68-73. doi: 10.1016/j.jelectrocard.2017.08.030. Epub 2017 Sep 1.


Electrocardiographic biomarkers to confirm drug's electrophysiological effects used for proarrhythmic risk prediction under CiPA.

Vicente J, Hosseini M, Johannesen L, Strauss DG.

J Electrocardiol. 2017 Nov - Dec;50(6):808-813. doi: 10.1016/j.jelectrocard.2017.08.003. Epub 2017 Aug 9.


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