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Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine.

Bussiere JL, Davies R, Dean C, Xu C, Kim KH, Vargas HM, Chellman GJ, Balasubramanian G, Rubio-Beltran E, MaassenVanDenBrink A, Monticello TM.

Regul Toxicol Pharmacol. 2019 Aug;106:224-238. doi: 10.1016/j.yrtph.2019.05.013. Epub 2019 May 11. Review.


"Thorough QT/QTc in a Dish": Can Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Predict Thorough QT Outcomes?

Vargas HM.

Clin Pharmacol Ther. 2019 May;105(5):1064-1066. doi: 10.1002/cpt.1384. Epub 2019 Mar 7. No abstract available.


Corrigendum to An overview of the safety pharmacology society strategic plan [Journal of Pharmacological and Toxicological Methods 93 (2018) 35-45].

Pugsley MK, Authier S, Koerner JE, Redfern WS, Markgraf CG, Brabham T, Correll K, Soloviev MV, Botchway A, Engwall M, Traebert M, Valentin JP, Mow TJ, Greiter-Wilke A, Leishman DJ, Vargas HM.

J Pharmacol Toxicol Methods. 2019 Jan - Feb;95:1. doi: 10.1016/j.vascn.2018.09.003. Epub 2018 Nov 3. No abstract available.


Decreased contractility and altered responses to inotropic agents in myocytes from tachypacing-induced heart failure canines.

Gao B, Qu Y, Sutherland W, Chui RW, Hoagland K, Vargas HM.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:98-107. doi: 10.1016/j.vascn.2018.06.001. Epub 2018 Jun 14.


Action Potential Recording and Pro-arrhythmia Risk Analysis in Human Ventricular Trabeculae.

Qu Y, Page G, Abi-Gerges N, Miller PE, Ghetti A, Vargas HM.

Front Physiol. 2018 Jan 5;8:1109. doi: 10.3389/fphys.2017.01109. eCollection 2017.


An overview of the safety pharmacology society strategic plan.

Pugsley MK, Authier S, Koerner JE, Redfern WS, Markgraf CG, Brabham T, Correll K, Soloviev MV, Botchway A, Engwall M, Traebert M, Valentin JP, Mow TJ, Greiter-Wilke A, Leishman DJ, Vargas HM.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:35-45. doi: 10.1016/j.vascn.2018.01.001. Epub 2018 Jan 9. Review. Erratum in: J Pharmacol Toxicol Methods. 2019 Jan - Feb;95:1.


Development of 2-aminooxazoline 3-azaxanthene β-amyloid cleaving enzyme (BACE) inhibitors with improved selectivity against Cathepsin D.

Low JD, Bartberger MD, Chen K, Cheng Y, Fielden MR, Gore V, Hickman D, Liu Q, Allen Sickmier E, Vargas HM, Werner J, White RD, Whittington DA, Wood S, Minatti AE.

Medchemcomm. 2017 Apr 27;8(6):1196-1206. doi: 10.1039/c7md00106a. eCollection 2017 Jun 1.


Proarrhythmia liability assessment and the comprehensive in vitro Proarrhythmia Assay (CiPA): An industry survey on current practice.

Authier S, Pugsley MK, Koerner JE, Fermini B, Redfern WS, Valentin JP, Vargas HM, Leishman DJ, Correll K, Curtis MJ.

J Pharmacol Toxicol Methods. 2017 Jul;86:34-43. doi: 10.1016/j.vascn.2017.02.021. Epub 2017 Feb 20.


Safety pharmacology investigations on the nervous system: An industry survey.

Authier S, Arezzo J, Delatte MS, Kallman MJ, Markgraf C, Paquette D, Pugsley MK, Ratcliffe S, Redfern WS, Stevens J, Valentin JP, Vargas HM, Curtis MJ.

J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:37-46. doi: 10.1016/j.vascn.2016.06.001. Epub 2016 Jun 2.


Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials.

Mead AN, Amouzadeh HR, Chapman K, Ewart L, Giarola A, Jackson SJ, Jarvis P, Jordaan P, Redfern W, Traebert M, Valentin JP, Vargas HM.

Regul Toxicol Pharmacol. 2016 Oct;80:348-57. doi: 10.1016/j.yrtph.2016.05.002. Epub 2016 May 4.


Proarrhythmia Risk Assessment in Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Using the Maestro MEA Platform.

Qu Y, Vargas HM.

Toxicol Sci. 2015 Sep;147(1):286-95. doi: 10.1093/toxsci/kfv128. Epub 2015 Jun 27.


Safety Pharmacology Evaluation of Biopharmaceuticals.

Amouzadeh HR, Engwall MJ, Vargas HM.

Handb Exp Pharmacol. 2015;229:385-404. doi: 10.1007/978-3-662-46943-9_15. Review.


Evaluation of drug-induced QT interval prolongation in animal and human studies: a literature review of concordance.

Vargas HM, Bass AS, Koerner J, Matis-Mitchell S, Pugsley MK, Skinner M, Burnham M, Bridgland-Taylor M, Pettit S, Valentin JP.

Br J Pharmacol. 2015 Aug;172(16):4002-11. doi: 10.1111/bph.13207. Epub 2015 Jul 14. Review.


The Diplomate in Safety Pharmacology (DSP) certification scheme.

Authier S, Curtis MJ, Soloviev M, Redfern WS, Kallman MJ, Hamlin RL, Leishman DJ, Valentin JP, Koerner JE, Vargas HM, Botchway A, Correll K, Pugsley MK.

J Pharmacol Toxicol Methods. 2015 Sep-Oct;75:1-4. doi: 10.1016/j.vascn.2015.04.008. Epub 2015 May 8.


An Orally Available BACE1 Inhibitor That Affords Robust CNS Aβ Reduction without Cardiovascular Liabilities.

Cheng Y, Brown J, Judd TC, Lopez P, Qian W, Powers TS, Chen JJ, Bartberger MD, Chen K, Dunn RT 2nd, Epstein O, Fremeau RT Jr, Harried S, Hickman D, Hitchcock SA, Luo Y, Minatti AE, Patel VF, Vargas HM, Wahl RC, Weiss MM, Wen PH, White RD, Whittington DA, Zheng XM, Wood S.

ACS Med Chem Lett. 2014 Dec 29;6(2):210-5. doi: 10.1021/ml500458t. eCollection 2015 Feb 12.


Oxytocin does not directly alter cardiac repolarization in rabbit or human cardiac myocytes.

Qu Y, Fang M, Gao B, Amagasu S, Crumb WJ, Vargas HM.

Pharmacol Res Perspect. 2015 Feb;3(1):e00102. doi: 10.1002/prp2.102. Epub 2014 Dec 9.


Development of 2-aminooxazoline 3-azaxanthenes as orally efficacious β-secretase inhibitors for the potential treatment of Alzheimer's disease.

Chen JJ, Liu Q, Yuan C, Gore V, Lopez P, Ma V, Amegadzie A, Qian W, Judd TC, Minatti AE, Brown J, Cheng Y, Xue M, Zhong W, Dineen TA, Epstein O, Human J, Kreiman C, Marx I, Weiss MM, Hitchcock SA, Powers TS, Chen K, Wen PH, Whittington DA, Cheng AC, Bartberger MD, Hickman D, Werner JA, Vargas HM, Everds NE, Vonderfecht SL, Dunn RT 2nd, Wood S, Fremeau RT Jr, White RD, Patel VF.

Bioorg Med Chem Lett. 2015 Feb 15;25(4):767-74. doi: 10.1016/j.bmcl.2014.12.092. Epub 2015 Jan 8.


The concordance between nonclinical and phase I clinical cardiovascular assessment from a cross-company data sharing initiative.

Ewart L, Aylott M, Deurinck M, Engwall M, Gallacher DJ, Geys H, Jarvis P, Ju H, Leishman D, Leong L, McMahon N, Mead A, Milliken P, Suter W, Teisman A, Van Ammel K, Vargas HM, Wallis R, Valentin JP.

Toxicol Sci. 2014 Dec;142(2):427-35. doi: 10.1093/toxsci/kfu198. Epub 2014 Sep 21.


Detection of QTc interval prolongation using jacket telemetry in conscious non-human primates: comparison with implanted telemetry.

Derakhchan K, Chui RW, Stevens D, Gu W, Vargas HM.

Br J Pharmacol. 2014 Jan;171(2):509-22. doi: 10.1111/bph.12484.


Safety pharmacology investigations in toxicology studies: an industry survey.

Authier S, Vargas HM, Curtis MJ, Holbrook M, Pugsley MK.

J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):44-51. doi: 10.1016/j.vascn.2013.05.002. Epub 2013 May 14.


A public-private consortium advances cardiac safety evaluation: achievements of the HESI Cardiac Safety Technical Committee.

Pierson JB, Berridge BR, Brooks MB, Dreher K, Koerner J, Schultze AE, Sarazan RD, Valentin JP, Vargas HM, Pettit SD.

J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):7-12. doi: 10.1016/j.vascn.2013.03.008. Epub 2013 Apr 6.


Human embryonic stem cell derived cardiac myocytes detect hERG-mediated repolarization effects, but not Nav1.5 induced depolarization delay.

Qu Y, Gao B, Fang M, Vargas HM.

J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):74-81. doi: 10.1016/j.vascn.2013.03.001. Epub 2013 Mar 19.


Itraconazole decreases left ventricular contractility in isolated rabbit heart: mechanism of action.

Qu Y, Fang M, Gao B, Amouzadeh HR, Li N, Narayanan P, Acton P, Lawrence J, Vargas HM.

Toxicol Appl Pharmacol. 2013 Apr 15;268(2):113-22. doi: 10.1016/j.taap.2013.01.029. Epub 2013 Feb 13.


Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals.

Vargas HM, Amouzadeh HR, Engwall MJ.

Expert Opin Drug Saf. 2013 Jan;12(1):91-102. doi: 10.1517/14740338.2013.745851. Epub 2012 Nov 21. Review.


Comprehensive analysis of cardiac arrhythmias in telemetered cynomolgus monkeys over a 6 month period.

Chui RW, Derakhchan K, Vargas HM.

J Pharmacol Toxicol Methods. 2012 Sep;66(2):84-91. doi: 10.1016/j.vascn.2012.05.002. Epub 2012 May 14.


Off-target platelet activation in macaques unique to a therapeutic monoclonal antibody.

Santostefano MJ, Kirchner J, Vissinga C, Fort M, Lear S, Pan WJ, Prince PJ, Hensley KM, Tran D, Rock D, Vargas HM, Narayanan P, Jawando R, Rees W, Reindel JF, Reynhardt K, Everds N.

Toxicol Pathol. 2012 Aug;40(6):899-917. doi: 10.1177/0192623312444029. Epub 2012 May 2.


Design and synthesis of potent, orally efficacious hydroxyethylamine derived β-site amyloid precursor protein cleaving enzyme (BACE1) inhibitors.

Dineen TA, Weiss MM, Williamson T, Acton P, Babu-Khan S, Bartberger MD, Brown J, Chen K, Cheng Y, Citron M, Croghan MD, Dunn RT 2nd, Esmay J, Graceffa RF, Harried SS, Hickman D, Hitchcock SA, Horne DB, Huang H, Imbeah-Ampiah R, Judd T, Kaller MR, Kreiman CR, La DS, Li V, Lopez P, Louie S, Monenschein H, Nguyen TT, Pennington LD, San Miguel T, Sickmier EA, Vargas HM, Wahl RC, Wen PH, Whittington DA, Wood S, Xue Q, Yang BH, Patel VF, Zhong W.

J Med Chem. 2012 Nov 8;55(21):9025-44. doi: 10.1021/jm300118s. Epub 2012 Apr 18.


hERG potency estimates based upon dose solution analysis: What have we learned?

Qu Y, Schnier P, Zanon R, Vargas HM.

J Pharmacol Toxicol Methods. 2011 Nov-Dec;64(3):251-7. doi: 10.1016/j.vascn.2011.08.004. Epub 2011 Aug 23.


Safety pharmacology in 2010 and beyond: survey of significant events of the past 10 years and a roadmap to the immediate-, intermediate- and long-term future in recognition of the tenth anniversary of the Safety Pharmacology Society.

Bass AS, Vargas HM, Valentin JP, Kinter LB, Hammond T, Wallis R, Siegl PK, Yamamoto K.

J Pharmacol Toxicol Methods. 2011 Jul-Aug;64(1):7-15. doi: 10.1016/j.vascn.2011.05.006. Epub 2011 Jun 12. Review.


Discovery of AMG 369, a Thiazolo[5,4-b]pyridine Agonist of S1P1 and S1P5.

Cee VJ, Frohn M, Lanman BA, Golden J, Muller K, Neira S, Pickrell A, Arnett H, Buys J, Gore A, Fiorino M, Horner M, Itano A, Lee MR, McElvain M, Middleton S, Schrag M, Rivenzon-Segal D, Vargas HM, Xu H, Xu Y, Zhang X, Siu J, Wong M, Bürli RW.

ACS Med Chem Lett. 2010 Dec 29;2(2):107-12. doi: 10.1021/ml100306h. eCollection 2011 Feb 10.


Discovery of a Potent, S1P3-Sparing Benzothiazole Agonist of Sphingosine-1-Phosphate Receptor 1 (S1P1).

Lanman BA, Cee VJ, Cheruku SR, Frohn M, Golden J, Lin J, Lobera M, Marantz Y, Muller KM, Neira SC, Pickrell AJ, Rivenzon-Segal D, Schutz N, Sharadendu A, Yu X, Zhang Z, Buys J, Fiorino M, Gore A, Horner M, Itano A, McElvain M, Middleton S, Schrag M, Vargas HM, Xu H, Xu Y, Zhang X, Siu J, Bürli RW.

ACS Med Chem Lett. 2010 Nov 9;2(2):102-6. doi: 10.1021/ml100228m. eCollection 2011 Feb 10.


Benzofuran Derivatives as Potent, Orally Active S1P1 Receptor Agonists: A Preclinical Lead Molecule for MS.

Saha AK, Yu X, Lin J, Lobera M, Sharadendu A, Chereku S, Schutz N, Segal D, Marantz Y, McCauley D, Middleton S, Siu J, Bürli RW, Buys J, Horner M, Salyers K, Schrag M, Vargas HM, Xu Y, McElvain M, Xu H.

ACS Med Chem Lett. 2010 Nov 9;2(2):97-101. doi: 10.1021/ml100227q. eCollection 2011 Feb 10.


BeKm-1, a peptide inhibitor of human ether-a-go-go-related gene potassium currents, prolongs QTc intervals in isolated rabbit heart.

Qu Y, Fang M, Gao B, Chui RW, Vargas HM.

J Pharmacol Exp Ther. 2011 Apr;337(1):2-8. doi: 10.1124/jpet.110.176883. Epub 2010 Dec 23.


A new preclinical biomarker for risk of Torsades de Pointes: drug-induced reduction of the cardiac electromechanical window.

Vargas HM.

Br J Pharmacol. 2010 Dec;161(7):1441-3. doi: 10.1111/j.1476-5381.2010.00980.x.


Current challenges in the evaluation of cardiac safety during drug development: translational medicine meets the Critical Path Initiative.

Piccini JP, Whellan DJ, Berridge BR, Finkle JK, Pettit SD, Stockbridge N, Valentin JP, Vargas HM, Krucoff MW; CSRC/HESI Writing Group.

Am Heart J. 2009 Sep;158(3):317-26. doi: 10.1016/j.ahj.2009.06.007. Epub 2009 Jul 23.


A comparison of three software platforms for automated ECG analysis.

Chui RW, Vargas HM.

J Pharmacol Toxicol Methods. 2009 Jul-Aug;60(1):28-38. doi: 10.1016/j.vascn.2009.05.004. Epub 2009 May 23.


Assessment of two external telemetry systems (PhysioJacket and JET) in beagle dogs with telemetry implants.

Chui RW, Fosdick A, Conner R, Jiang J, Bruenner BA, Vargas HM.

J Pharmacol Toxicol Methods. 2009 Jul-Aug;60(1):58-68. doi: 10.1016/j.vascn.2009.04.196. Epub 2009 May 5.


Discovery of 1,4-substituted piperidines as potent and selective inhibitors of T-type calcium channels.

Yang ZQ, Barrow JC, Shipe WD, Schlegel KA, Shu Y, Yang FV, Lindsley CW, Rittle KE, Bock MG, Hartman GD, Uebele VN, Nuss CE, Fox SV, Kraus RL, Doran SM, Connolly TM, Tang C, Ballard JE, Kuo Y, Adarayan ED, Prueksaritanont T, Zrada MM, Marino MJ, Graufelds VK, DiLella AG, Reynolds IJ, Vargas HM, Bunting PB, Woltmann RF, Magee MM, Koblan KS, Renger JJ.

J Med Chem. 2008 Oct 23;51(20):6471-7. doi: 10.1021/jm800830n. Epub 2008 Sep 26.


Design, synthesis, and evaluation of a novel 4-aminomethyl-4-fluoropiperidine as a T-type Ca2+ channel antagonist.

Shipe WD, Barrow JC, Yang ZQ, Lindsley CW, Yang FV, Schlegel KA, Shu Y, Rittle KE, Bock MG, Hartman GD, Tang C, Ballard JE, Kuo Y, Adarayan ED, Prueksaritanont T, Zrada MM, Uebele VN, Nuss CE, Connolly TM, Doran SM, Fox SV, Kraus RL, Marino MJ, Graufelds VK, Vargas HM, Bunting PB, Hasbun-Manning M, Evans RM, Koblan KS, Renger JJ.

J Med Chem. 2008 Jul 10;51(13):3692-5. doi: 10.1021/jm800419w. Epub 2008 Jun 10.


Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics.

Vargas HM, Bass AS, Breidenbach A, Feldman HS, Gintant GA, Harmer AR, Heath B, Hoffmann P, Lagrutta A, Leishman D, McMahon N, Mittelstadt S, Polonchuk L, Pugsley MK, Salata JJ, Valentin JP.

J Pharmacol Toxicol Methods. 2008 Sep-Oct;58(2):72-6. doi: 10.1016/j.vascn.2008.04.001. Epub 2008 Apr 18.


4-Fluorosulfonylpiperidines: selective 5-HT2A ligands for the treatment of insomnia.

Fish LR, Gilligan MT, Humphries AC, Ivarsson M, Ladduwahetty T, Merchant KJ, O'Connor D, Patel S, Philipps E, Vargas HM, Hutson PH, MacLeod AM.

Bioorg Med Chem Lett. 2005 Aug 15;15(16):3665-9.


Introduction to nonclinical safety pharmacology and the safety pharmacology society.

Bass AS, Vargas HM, Kinter LB.

J Pharmacol Toxicol Methods. 2004 May-Jun;49(3):141-4. No abstract available.


Synthesis and structure-activity relationship of the isoindolinyl benzisoxazolpiperidines as potent, selective, and orally active human dopamine D4 receptor antagonists.

Hendrix JA, Shimshock SJ, Shutske GM, Tomer JD 4th, Kapples KJ, Palermo MG, Corbett TJ, Vargas HM, Kafka S, Brooks KM, Laws-Ricker L, Lee DK, de Lannoy I, Bordeleau M, Rizkalla G, Owolabi J, Kamboj RK.

Chembiochem. 2002 Oct 4;3(10):999-1009.


Interaction of clozapine and other antipsychotic drugs with human alpha 1-adrenergic receptor subtypes.

Brooks KM, Cai J, Sandrasagra A, Roehr JE, Errazo R, Vargas HM.

Proc West Pharmacol Soc. 1999;42:67-9. No abstract available.


alpha-Adrenergic activity and cardiovascular effects of besipirdine HCl (HP 749) and metabolite P7480 in vitro and in the conscious rat and dog.

Hubbard JW, Nordstrom ST, Smith CP, Brooks KM, Laws-Ricker L, Zhou L, Vargas HM.

J Pharmacol Exp Ther. 1997 Apr;281(1):337-46.


Pharmacological activity and safety profile of P10358, a novel, orally active acetylcholinesterase inhibitor for Alzheimer's disease.

Smith CP, Bores GM, Petko W, Li M, Selk DE, Rush DK, Camacho F, Winslow JT, Fishkin R, Cunningham DM, Brooks KM, Roehr J, Hartman HB, Davis L, Vargas HM.

J Pharmacol Exp Ther. 1997 Feb;280(2):710-20.


Pharmacological evaluation of novel Alzheimer's disease therapeutics: acetylcholinesterase inhibitors related to galanthamine.

Bores GM, Huger FP, Petko W, Mutlib AE, Camacho F, Rush DK, Selk DE, Wolf V, Kosley RW Jr, Davis L, Vargas HM.

J Pharmacol Exp Ther. 1996 May;277(2):728-38.


Alpha 2-adrenoceptor antagonists potentiate acetylcholinesterase inhibitor effects on passive avoidance learning in the rat.

Camacho F, Smith CP, Vargas HM, Winslow JT.

Psychopharmacology (Berl). 1996 Apr;124(4):347-54.


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