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  5. Division of Applied Regulatory Science - Recent Publications
  1. Center for Drug Evaluation and Research | CDER

Division of Applied Regulatory Science - Recent Publications

2019

Regulatory Science

Bai JPF, Earp JC, Pillai VC. Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices. AAPS J. 2019;21(4):72. PMID: 31161268

Bai JPF, Musante CJ, Petanceska S, Zhang L, Zhao L, Zhao P. American Society for Clinical Pharmacology and Therapeutics 2019 Annual Meeting Pre-Conferences. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31087531

Guth BD, Engwall M, Eldridge S, Foley CM, Guo L, Gintant G, Koerner J, Parish ST, Pierson JB, Ribeiro AJS, Zabka T, Chaudhary KW, Kanda Y, Berridge B. Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms. Front Pharmacol. 2019;10:884. PMID: 31447679

Madabushi R, Benjamin JM, Grewal R, Pacanowski MA, Strauss DG, Wang Y, Zhu H, Zineh I. The US Food and Drug Administration's Model-Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact. Clin Pharmacol Ther. 2019;106(1):74-8. PMID: 31081932

Vicente J, Strauss DG, Upreti VV, Fossler MJ, Sager PT, Noveck R. The Potential Role of the J-Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium. Journal of clinical pharmacology. 2019. PMID: 30907981

Wang YC, Strauss DG, Huang SM. Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions. Biomark Med. 2019. PMID: 31210051

Zhu H, Huang SM, Madabushi R, Strauss DG, Wang Y, Zineh I. Model-Informed Drug Development: A Regulatory Perspective on Progress. Clin Pharmacol Ther. 2019;106(1):91-3. PMID: 31162631

Clinical Research

Hnatkova K, Vicente J, Johannesen L, Garnett C, Strauss DG, Stockbridge N, Malik M. Detection of T Wave Peak for Serial Comparisons of JTp Interval. Front Physiol. 2019;10:934. PMID: 31402872

Lee JE, Wang J, Florian J, Wang YM, Kettl D, Marcus K, Woitach A. Effect of Body Weight on Risk-Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis. Clin Pharmacol Ther. 2019;106(1):78-80. PMID: 31188469

Loring Z, Atwater BD, Xia X, Axelsson J, Klem I, Nijveldt R, et al. Low lead one ratio predicts clinical outcomes in left bundle branch block. Journal of cardiovascular electrophysiology. 2019. PMID: 30740823

Mason JW, Strauss DG, Vaglio M, Badilini F. Correction of the QRS duration for heart rate. J Electrocardiol. 2019;54:1-4. PMID: 30782546

Matta MK, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Florian J, Oh L, Bashaw E, Zineh I, Sanabria C, Kemp S, Godfrey A, Adah S, Coelho S, Wang J, Furlong LA, Ganley C, Michele T, Strauss DG. Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial. JAMA. 2019. PMID: 31058986

McDowell TY, Lawrence J, Florian J, Southworth MR, Grant S, Stockbridge N. Relationship between International Normalized Ratio and Outcomes in Modern Trials with Warfarin Controls. Pharmacotherapy. 2018;38(9):899-906. PMID: 29920722

Non-Clinical Research

Blinova K, Schocken D, Patel D, Daluwatte C, Vicente J, Wu JC, Strauss DG. Clinical trial in a dish: personalized stem cell derived cardiomyocyte assay compared to clinical trial results for two QT prolonging drugs. Clin Transl Sci. 2019. PMID: 31328865

Chockalingam A, Xu L, Stewart S, LeMerdy M, Tsakalozou E, Fan J, Patel V, Rouse R. Protocol for evaluation of topical ophthalmic drug products in different compartments of fresh eye tissues in a rabbit model. J Pharmacol Toxicol Methods. 2019;96:9-14. PMID: 30552958

Indapurkar A, Hartman N, Patel V, Matta MK. Simultaneous UHPLC-MS/MS method of estradiol metabolites to support the evaluation of Phase-2 metabolic activity of induced pluripotent stem cell derived hepatocytes. J Chromatogr B Analyt Technol Biomed Life Sci. 2019;1126-1127:121765. PMID: 31434025

Le Merdy M, Fan J, Bolger MB, Lukacova V, Spires J, Tsakalozou E, Patel V, Xu L, Stewart S, Chockalingam A, Narayanasamy S, Rouse R, Matta M, Babiskin A, Kozak D, Choi S, Zhang L, Lionberger R, Zhao L. Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension. AAPS J. 2019;21(4):65. PMID: 31111305

Narayanasamy S, Pilli NR, Xu L, Chockalingam A, Shea KI, Stewart S, Patel V, Rouse R, Matta MK. An alternating polarity switching assay for quantification of oxycodone and topiramate: An application of LC-MS/MS method in support to PK/PD study in rodents. J Chromatogr B Analyt Technol Biomed Life Sci. 2019;1118-1119:93-100. PMID: 31030106

Patel D, Stohlman J, Dang Q, Strauss DG, Blinova K. Assessment of proarrhythmic potential of drugs in optogenetically paced induced pluripotent stem cell-derived cardiomyocytes. Toxicol Sci. 2019. PMID: 30912807

Ribeiro AJS, Yang X, Patel V, Madabushi R, Strauss DG. Liver Microphysiological Systems for Predicting and Evaluating Drug Effects. Clin Pharmacol Ther. 2019. PMID: 30993668

Ribeiro AJS, Guth BD, Engwall M, Eldridge S, Foley CM, Guo L, Gintant G, Koerner J, Parish ST, Pierson JB, Brock M, Chaudhary KW, Kanda Y, Berridge B. Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Drug-Induced Inotropic Effects in Early Drug Development. Part 2: Designing and Fabricating Microsystems for Assaying Cardiac Contractility With Physiological Relevance Using Human iPSC-Cardiomyocytes. Front Pharmacol. 2019;10:934. PMID: 31555128

Semple KM, Gonzalez CM, Zarr M, Austin JR, Patel V, Howard KE. Evaluation of the Ability of Immune Humanized Mice to Demonstrate CD20-Specific Cytotoxicity Induced by Ofatumumab. Clin Transl Sci. 2019. PMID: 30737892

Shea K, Rouse R. Detection of Reg3gamma by Immunohistochemistry in Cerulein-Induced Model of Acute Pancreatic Injury in Mice and Rats. Pancreas. 2019;48(8):1015-25. PMID: 31404030

Weaver JL, Zadrozny LM, Gabrielson K, Semple KM, Shea KI, Howard KE. BLT-immune humanized mice as a model for nivolumab induced immune-mediated adverse events: Comparison of the NOG and NOG-EXL strains. Toxicol Sci. 2019. PMID: 30850839

Wu M, Tran PN, Sheng J, Randolph AL, Wu WW. Drug potency on inhibiting late Na(+) current is sensitive to gating modifier and current region where drug effects were measured. J Pharmacol Toxicol Methods. 2019:106605. PMID: 31255744

Yan H, Semple KM, Gonzalez CM, Howard KE. Bone marrow-liver-thymus (BLT) immune humanized mice as a model to predict cytokine release syndrome. Transl Res. 2019;210:43-56. PMID: 31082370

Generics and Biosimilars

Gandhi A, Matta M, Zere T, Weaver J. Combining LC-MS/MS and hollow-fiber infection model for real-time quantitation of ampicillin to antimicrobial resistance. Future science OA. 2019;5(1):FSO349. PMID: 30652018

Matta MK, Narayanasamy S, Vicente J, Zusterzeel R, Patel V, Strauss DG. Novel High-Throughput Quantitation of Potent hERG Blocker Dofetilide in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application in a Phase 1 ECG Biomarker Validation Study. J Anal Toxicol. 2019. PMID: 31355881

Yan H, Bhagwat B, Sanden D, Willingham A, Tan A, Knapton AD, et al. Evaluation of a TGN1412 analogue using in vitro assays and two immune humanized mouse models. Toxicology and applied pharmacology. 2019. PMID: 30914376

Younis IR, Lakota EA, Volpe DA, Patel V, Xu Y, Sahajwalla CG. Drug-Drug Interaction Studies of Methadone and Antiviral Drugs: Lessons Learned. J Clin Pharmacol. 2019. PMID: 30973652

In Silico Research

Amberg A, Anger LT, Bercu J, Bower D, Cross KP, Custer L, et al. Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity? Mutagenesis. 2019;34(1):67-82. PMID: 30189015

Ellis CR, Racz R, Kruhlak NL, Kim MT, Hawkins EG, Strauss DG, et al. Assessing the Structural and Pharmacological Similarity of Newly Identified Drugs of Abuse to Controlled Substances Using Public Health Assessment via Structural Evaluation. Clin Pharmacol Ther. 2019. PMID: 30957872

Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger LT, Atienzar F, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Cammerer Z, Cronin MTD, Crooks I, Cross KP, Custer L, Dobo K, Doktorova T, Faulkner D, Ford KA, Fortin MC, Frericks M, Gad-McDonald SE, Gellatly N, Gerets H, Gervais V, Glowienke S, Van Gompel J, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Barton-Maclaren TS, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kruhlak NL, Kulkarni SA, Kummerer K, Leavitt P, Masten S, Miller S, Moudgal C, Muster W, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Schilter B, Snyder RD, Stavitskaya L, Stidl R, Szabo DT, Teasdale A, Tice RR, Trejo-Martin A, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Myatt GJ. Genetic toxicology in silico protocol. Regul Toxicol Pharmacol. 2019;107:104403. PMID: 31195068

Li Z, Garnett C, Strauss DG. Quantitative Systems Pharmacology Models for a New International Cardiac Safety Regulatory Paradigm: An Overview of the Comprehensive In Vitro Proarrhythmia Assay In Silico Modeling Approach. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31044559

Melas IN, Sakellaropoulos T, Hur J, Messinis D, Guo EY, Alexopoulos LG, et al. A Computational Platform and Guide for Acceleration of Novel Medicines and Personalized Medicine. Methods in molecular biology. 2019;1939:181-98. PMID: 30848462


2018

Regulatory Science

Blank M, Thompson A, Hausner E, Rouse R. Biomarkers of drug-induced acute kidney injury: a regulatory perspective. Expert opinion on drug metabolism & toxicology. 2018;14(9):929-36. PMID: 30099912

Chan N, Sager PT, Lawrence J, Ortel T, Reilly P, Berkowitz S, et al. Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants? Am Heart J. 2018;199:59-67. PMID: 29754667

Rouse R, Zineh I, Strauss DG. Regulatory Science - An Underappreciated Component of Translational Research. Trends Pharmacol Sci. 2018;39(3):225-9. PMID: 29329784

Rouse R, Kruhlak N, Weaver J, Burkhart K, Patel V, Strauss DG. Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science. Ther Innov Regul Sci. 2018;52(2):244-55. PMID: 29568713

Wallis R, Benson C, Darpo B, Gintant G, Kanda Y, Prasad K, et al. CiPA challenges and opportunities from a non-clinical, clinical and regulatory perspectives. An overview of the safety pharmacology scientific discussion. J Pharmacol Toxicol Methods. 2018;93:15-25. PMID: 29958940

Clinical Research

Axelsson J, Wieslander B, Jablonowski R, Klem I, Nijveldt R, Schelbert EB, et al. Ejection fraction in left bundle branch block is disproportionately reduced in relation to amount of myocardial scar. J Electrocardiol. 2018;51(6):1071-6. PMID: 30497733

Azarbaijani Y, O'Callaghan K, Sanders WE, Wu C, Laschinger J, Marinac-Dabic D, et al. Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: A Review of the Literature. Cardiol Rev. 2018;26(2):73-81. PMID: 29053483

Daluwatte C, Vicente J, Galeotti L, Johannesen L, Strauss DG, Scully CG. A novel ECG detector performance metric and its relationship with missing and false heart rate limit alarms. J Electrocardiol. 2018;51(1):68-73. PMID: 28964425

Ochoa-Jimenez R, Viquez-Beita K, Daluwatte C, Zusterzeel R. Sex Differences of Patients With Systemic Hypertension (From the Analysis of the Systolic Blood Pressure Intervention Trial [SPRINT]). The American journal of cardiology. 2018;122(6):985-93. PMID: 30072129

Vicente J. Update on the ECG component of the CiPA initiative. J Electrocardiol. 2018. PMID: 30121123

Vicente J, Hosseini M, Johannesen L, Strauss DG. Electrocardiographic biomarkers to confirm drug's electrophysiological effects used for proarrhythmic risk prediction under CiPA. J Electrocardiol. 2017;50(6):808-13. PMID: 28928044

Vicente J, Zusterzeel R, Johannesen L, Ochoa-Jimenez R, Mason JW, Sanabria C, et al. 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. PMID: 30447156

Vicente J, Zusterzeel R, Johannesen L, Mason J, Sager P, Patel V, et al. Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study. Clin Pharmacol Ther. 2018;103(1):54-66. PMID: 28986934

Volpe DA. Interindividual Variability in Drug Metabolizing Enzymes. Current drug metabolism. 2018. PMID: 30117390

Wieslander B, Xia X, Jablonowski R, Axelsson J, Klem I, Nijveldt R, et al. The ability of the electrocardiogram in left bundle branch block to detect myocardial scar determined by cardiovascular magnetic resonance. J Electrocardiol. 2018;51(5):779-86. PMID: 30177312

Yousuf OK, Zusterzeel R, Sanders W, Canos D, Dekmezian C, Silverman H, et al. Trends and Outcomes of Catheter Ablation for Ventricular Tachycardia in a Community Cohort. JACC Clinical electrophysiology. 2018;4(9):1189-99. PMID: 30236393

Yu LR, Cao Z, Makhoul I, Daniels JR, Klimberg S, Wei JY, et al. Immune response proteins as predictive biomarkers of doxorubicin-induced cardiotoxicity in breast cancer patients. Exp Biol Med(Maywood). 2018;243(3):248-55. PMID: 29224368

Zusterzeel R. Safety and Effectiveness of Medical Device Therapy. Advances in experimental medicine and biology. 2018;1065:107-21. PMID: 30051380

Zusterzeel R, Mishra NK, Beydoun H, Laschinger J, Wu C, Dong LM, et al. Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: FDA Patient-Level Meta-Analysis of Premarket Clinical Trials. J Womens Health (Larchmt). 2018;27(6):808-14. PMID: 29741978

Non-Clinical Research

Bai JPF, Hsu CW. Drug repurposing for Ebola virus disease: principles of consideration and the Animal Rule. Journal of pharmaceutical sciences. 2018. PMID: 30244014

Blinova K, Dang Q, Millard D, Smith G, Pierson J, Guo L, et al. International Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment. Cell reports. 2018;24(13):3582-92. PMID: 30257217

Boulay E, Abernathy MM, Chu R, Friedrichs GS, Gendron-Parra N, Greiter-Wilke A, et al. A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium. International journal of toxicology. 2018:1091581818813601. PMID: 30567462

Chockalingam A, Xu L, Stewart S, LeMerdy M, Tsakalozou E, Fan J, et al. Protocol for evaluation of topical ophthalmic drug products in different compartments of fresh eye tissues in a rabbit model. Journal of pharmacological and toxicological methods. 2018;96:9-14. PMID: 30552958

Li Z, Rouse R. Co-sequencing and novel delayed anti-correlation identify function for pancreatic enriched microRNA biomarkers in a rat model of acute pancreatic injury. BMC Genomics. 2018;19(1):297. PMID: 29699499

Pine PS, Lund SP, Parsons JR, Vang LK, Mahabal AA, Cinquini L, et al. Summarizing performance for genome scale measurement of miRNA: reference samples and metrics. BMC Genomics. 2018;19(1):180. PMID: 29510677

Qosa H, Avaritt BR, Hartman NR, Volpe DA. In vitro UGT1A1 inhibition by tyrosine kinase inhibitors and association with drug-induced hyperbilirubinemia. Cancer chemotherapy and pharmacology. 2018;82(5):795-802. PMID: 30105461

Qosa H, Volpe DA. The development of biological therapies for neurological diseases: moving on from previous failures. Expert Opin Drug Discov. 2018;13(4):283-93. PMID: 29394876

Schocken D, Stohlman J, Vicente J, Chan D, Patel D, Matta MK, et al. Comparative analysis of media effects on human induced pluripotent stem cell-derived cardiomyocytes in proarrhythmia risk assessment. J Pharmacol Toxicol Methods. 2018;90:39-47. PMID: 29155283

Sheng J, Tran PN, Li Z, Dutta S, Chang K, Colatsky T, et al. Characterization of loperamide-mediated block of hERG channels at physiological temperature and its proarrhythmia propensity. J Pharmacol Toxicol Methods. 2017;88(Pt 2):109-22. PMID: 28830713

Volpe DA, Balimane PV. Application of in vitro CYP and transporter assays to predict clinical drug-drug interactions. Bioanalysis. 2018;10(9):619-23. PMID: 29768028

Volpe DA, Qosa H. Challenges with the precise prediction of ABC-transporter interactions for improved drug discovery. Expert Opin Drug Discov. 2018;13(8):697-707. PMID: 29943645

Walsh N, Zhang H, Hyland PL, Yang Q, Mocci E, Zhang M, et al. Agnostic Pathway/Gene Set Analysis of Genome-Wide Association Data Identifies Associations for Pancreatic Cancer. Journal of the National Cancer Institute. 2018. PMID: 30541042

Zadrozny LM, Brinster LR, Rosenzweig BA, Howard KE. Outbreak of Opportunistic Ascending Pyelonephritis with Numerous Yeast after Experimental Humanization Surgery in NOD.Cg-Prkdc(scid) Il2rg(tm1Wjl)/SzJ and NOD.Cg-Rag1(tm1Mom) Il2rg(tm1Wjl)/SzJ Immunodeficient Mice. Comparative medicine. 2018;68(5):353-9. PMID: 30208988

Generics and Biosimilars

Gandhi A, Beekman C, Parker R, Fang L, Babiskin A, Matta MK. Novel and rapid LC-MS/MS method for quantitative analysis of methylphenidate in dried blood spots. Bioanalysis. 2018;10(11):839-50. PMID: 29863895

Gandhi A, Matta M, Garimella N, Zere T, Weaver J. Development and validation of a LC-MS/MS method for quantitation of fosfomycin - Application to in vitro antimicrobial resistance study using hollow-fiber infection model. Biomed Chromatogr. 2018;32(6):e4214. PMID: 29461629

Matta MK CA, Gandhi A, Stewart S, Xu L, Shea K, Patel V, Rouse R. High throughput LC-MS/MS method for determination of ciprofloxacin in plasma, urine, bladder, and kidneys of mice. Anal Methods. 2018;10:1237-46.

Matta MK NS, Thomas CD, Xu L, Leigh J, Stewart S, Chockalingam A, Patel V, Rouse R. A sensitive UPLC-APCI-MS/MS method for the determination of dexamethasone and its application in an ocular tissue distribution study in rabbits following topical administration. Anal Methods. 2018;10:2307-16.

Matta MK, Beekman CR, Gandhi A, Narayanasamy S, Thomas CD, Mohammad A, et al. Determination of Non-Transferrin Bound Iron, Transferrin Bound Iron, Drug Bound Iron and Total Iron in Serum in a Rats after IV Administration of Sodium Ferric Gluconate Complex by Simple Ultrafiltration Inductively Coupled Plasma Mass Spectrometric Detection. Nanomaterials (Basel). 2018;8(2). PMID: 29439469

Sommers C, Rosenzweig B, Oum L, Thompson K, Keire DA. Quantitation of residual host cell DNA in protaminesulfate drug product by qPCR. Journal of pharmaceutical and biomedical analysis. 2018;160:238-43. PMID: 30103118

Sommers C, Rosenzweig B, Oum L, Thompson K, Keire DA. Development of methods for data quantitation of spiked salmon host cell DNA in protamine sulfate by qPCR. Data in brief. 2018;21:644-52. PMID: 30377650

Sun D, Rouse R, Patel V, Wu Y, Zheng J, Karmakar A, et al. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization. Nanomaterials (Basel). 2018;8(1). PMID: 29303999

Volpe DA, Xu Y, Sahajwalla CG, Younis IR, Patel V. Methadone Metabolism and Drug-Drug Interactions: In Vitro and In Vivo Literature Review. Journal of pharmaceutical sciences. 2018. PMID: 30205091

In Silico Research

Amberg A, Anger LT, Bercu J, Bower D, Cross KP, Custer L, et al. Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity? Mutagenesis. 2018. PMID:  30189015

Amberg A, Andaya RV, Anger LT, Barber C, Beilke L, Bercu J, et al. Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses. Regulatory toxicology and pharmacology : RTP. 2018;102:53-64. PMID: 30562600

Athif M, Yasawardene PC, Daluwatte C. Detecting atrial fibrillation from short single lead ECGs using statistical and morphological features. Physiol Meas. 2018;39(6):064002. PMID: 29767635

Bai JPF, Melas IN, Hur J, Guo E. Advances in omics for informed pharmaceutical research and development in the era of systems medicine. Expert Opin Drug Discov. 2018;13(1):1-4. PMID: 29073782

Ellis CR, Kruhlak NL, Kim MT, Hawkins EG, Stavitskaya L. Predicting opioid receptor binding affinity of pharmacologically unclassified designer substances using molecular docking. PLoS One. 2018;13(5):e0197734. PMID: 29795628

Hsu CW, Hewes KP, Stavitskaya L, Kruhlak NL. Construction and application of (Q)SAR models to predict chemical-induced in vitro chromosome aberrations. Regul Toxicol Pharmacol. 2018;99:274-88. PMID: 30278198

Li Z, Ridder BJ, Han X, Wu WW, Sheng J, Tran PN, et al. Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative. Clin Pharmacol Ther. 2018. PMID: 30151907

Malik M, Garnett C, Hnatkova K, Johannesen L, Vicente J, Stockbridge N. Importance of QT/RR hysteresis correction in studies of drug-induced QTc interval changes. J Pharmacokinet Pharmacodyn. 2018;45(3):491-503. PMID: 296515191

Malik M, Garnett C, Hnatkova K, Vicente J, Johannesen L, Stockbridge N. Implications of Individual QT/RR Profiles-Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections. Drug Saf. 2018. PMID: 30255349

Malik M, Garnett C, Hnatkova K, Vicente J, Johannesen L, Stockbridge N. Implications of Individual QT/RR Profiles-Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes. Drug Saf. 2018. PMID: 30255348

Messinis DE, Melas IN, Hur J, Varshney N, Alexopoulos LG, Bai JPF. Translational systems pharmacology-based predictive assessment of drug-induced cardiomyopathy. CPT Pharmacometrics Syst Pharmacol. 2018;7(3):166-74. PMID: 29341478

Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, et al. In silico toxicology protocols. Regul Toxicol Pharmacol. 2018;96:1-17. PMID: 29678766

Racz R, Soldatos TG, Jackson D, Burkhart K. Association Between Serotonin Syndrome and Second-Generation Antipsychotics via Pharmacological Target-Adverse Event Analysis. Clin Transl Sci. 2018;11(3):322-9. PMID: 29575568

Schotland P, Racz R, Jackson D, Levin R, Strauss DG, Burkhart K. Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities. CPT Pharmacometrics Syst Pharmacol. 2018. PMID: 30354029

Wilson JL, Racz R, Liu T, Adeniyi O, Sun J, Ramamoorthy A, et al. PathFX provides mechanistic insights into drug efficacy and safety for regulatory review and therapeutic development. PLoS Computational Biology. 2018;14(12):e1006614. PMID: 30532240


2017

Bioinformatics, Cheminformatics, and Systems Pharmacology

Bai JP, Sakellaropoulos T, Alexopoulos LG. A Biologically-Based Computational Approach to Drug Repurposing for Anthrax Infection. Toxins (Basel). 2017;9(3). PMID: 28287432

Critical Care Toxicology: Diagnosis and Management of the Critically Poisoned Patient. 2 ed. Brent J Burkhart K, Dargan P, Hatten B, Megarbane B, Palmer R, White J, editor: Springer International Publishing; 2017.

Dubcenco E, Beers-Block PM, Kim LP, Schotland P, Levine JG, McCloskey CA, Bashaw ED. A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety. Clin Transl Sci. 2017;10(5):387-94. PMID: 28618191

Animal Models

Khan S, Zhang Q, Marasa BS, Sung K, Cerniglia CE, Ingle T, Jones MY, Paredes AM, Tobin GA, Bancos S, Weaver JL, Goering PL, et al. Investigating the susceptibility of mice to a bacterial challenge after intravenous exposure to durable nanoparticles. Nanomedicine (Lond). 2017;12(17):2097-111. PMID: 28805153

Rouse R, Rosenzweig B, Shea K, Knapton A, Stewart S, Xu L, Chockalingam A, Zadrozny L, Thompson K. MicroRNA biomarkers of pancreatic injury in a canine model. Exp Toxicol Pathol. 2017;69(1):33-43. PMID: 27866884

Weaver JL, Tobin GA, Ingle T, Bancos S, Stevens D, Rouse R, Howard KE, Goodwin D, Knapton A, Li X, Shea K, Stewart S, et al. Evaluating the potential of gold, silver, and silica nanoparticles to saturate mononuclear phagocytic system tissues under repeat dosing conditions. Part Fibre Toxicol. 2017;14(1):25. PMID: 28716104

Pharmacokinetics and Clinical Pharmacology

Beekman CR, Matta M, Thomas CD, Mohammad A, Stewart S, Xu L, Chockalingam A, Shea K, Sun D, Jiang W, Patel V, Rouse R. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats. Nanomaterials (Basel). 2017;8(1). PMID: 29283393

Hartman N, Zhou H, Mao J, Mans D, Boyne M, 2nd, Patel V, Colatsky T. Characterization of the methemoglobin forming metabolites of benzocaine and lidocaine. Xenobiotica. 2017;47(5):431-8. PMID: 27321253

Lee SC, Arya V, Yang X, Volpe DA, Zhang L. Evaluation of transporters in drug development: Current status and contemporary issues. Adv Drug Deliv Rev. 2017;116:100-18. PMID: 28760687

Mehta MU, Uppoor RS, Conner DP, Seo P, Vaidyanathan J, Volpe DA, Stier E, Chilukuri D, Dorantes A, Ghosh T, Mandula H, Raines K, et al. Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development. Mol Pharm. 2017;14(12):4334-8. PMID: 29076742

Weaver J. Immunomodulation and the Risk for Neoplasia. In: C M, editor. Comprehensive Toxicology. 3 ed: Elsevier; 2017. p. 718-31.

Wu M, Sun D, Tyner K, Jiang W, Rouse R. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake. Nanomaterials (Basel). 2017;7(12). PMID: 29244729

Cardiac Safety

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, et al. Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias. Toxicol Sci. 2017;155(1):234-47. PMID: 27701120

Chang KC, Dutta S, Mirams GR, Beattie KA, Sheng J, Tran PN, Wu M, Wu WW, Colatsky T, Strauss DG, Li Z. Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment. Front Physiol. 2017;8:917. PMID: 29209226

Chaudhry U, Platonov PG, Jablonowski R, Couderc JP, Engblom H, Xia X, Wieslander B, Atwater BD, Strauss DG, Van der Pals J, Ugander M, Carlsson M, et al. Evaluation of the ECG based Selvester scoring method to estimate myocardial scar burden and predict clinical outcome in patients with left bundle branch block, with comparison to late gadolinium enhancement CMR imaging. Ann Noninvasive Electrocardiol. 2017;22(5). PMID: 28248005

Dutta S, Chang KC, Beattie KA, Sheng J, Tran PN, Wu WW, Wu M, Strauss DG, Colatsky T, Li Z. Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment. Front Physiol. 2017;8:616. PMID: 28878692

Gintant G, Fermini B, Stockbridge N, Strauss D. The Evolving Roles of Human iPSC-Derived Cardiomyocytes in Drug Safety and Discovery. Cell Stem Cell. 2017;21(1):14-7. PMID: 28686863

Li Z, Dutta S, Sheng J, Tran PN, Wu W, Chang K, Mdluli T, Strauss DG, Colatsky T. Improving the In Silico Assessment of Proarrhythmia Risk by Combining hERG (Human Ether-a-go-go-Related Gene) Channel-Drug Binding Kinetics and Multichannel Pharmacology. Circ Arrhythm Electrophysiol. 2017;10(2):e004628. PMID: 28202629

Sheng J, Tran PN, Li Z, Dutta S, Chang K, Colatsky T, Wu WW. Characterization of loperamide-mediated block of hERG channels at physiological temperature and its proarrhythmia propensity. J Pharmacol Toxicol Methods. 2017;88(Pt 2):109-22. PMID: 28830713

Strauss DG, Blinova K. Clinical Trials in a Dish. Trends Pharmacol Sci. 2017;38(1):4-7. PMID: 27876286

Strauss DG, Vicente J, Johannesen L, Blinova K, Mason JW, Weeke P, Behr ER, Roden DM, Woosley R, Kosova G, Rosenberg MA, Newton-Cheh C. Common Genetic Variant Risk Score Is Associated With Drug-Induced QT Prolongation and Torsade de Pointes Risk: A Pilot Study. Circulation. 2017;135(14):1300-10. PMID: 28213480

Vicente J, Hosseini M, Johannesen L, Strauss DG. Electrocardiographic biomarkers to confirm drug's electrophysiological effects used for proarrhythmic risk prediction under CiPA. J Electrocardiol. 2017;50(6):808-13. PMID: 28928044

Yaghouby F, Daluwatte C, Fukuda S, Nelson C, Salsbury J, Kinsky M, Kramer GC, Strauss DG, Enkhbaatar P, Scully CG. Progression and variability of physiologic deterioration in an ovine model of lung infection sepsis. J Appl Physiol (1985). 2017;123(1):172-81. PMID: 28473609

Cell-based Drug Evaluation Platforms

Judge LM, Perez-Bermejo JA, Truong A, Ribeiro AJ, Yoo JC, Jensen CL, Mandegar MA, Huebsch N, Kaake RM, So PL, Srivastava D, Pruitt BL, et al. A BAG3 chaperone complex maintains cardiomyocyte function during proteotoxic stress. JCI Insight. 2017;2(14). PMID: 28724793

Ribeiro AJS, Schwab O, Mandegar MA, Ang YS, Conklin BR, Srivastava D, Pruitt BL. Multi-Imaging Method to Assay the Contractile Mechanical Output of Micropatterned Human iPSC-Derived Cardiac Myocytes. Circ Res. 2017;120(10):1572-83. PMID: 28400398

Genomics

Cook MB, Wood S, Hyland PL, Caron P, Drahos J, Falk RT, Pfeiffer RM, Dawsey SM, Abnet CC, Taylor PR, Guillemette C, Murray LJ, et al. Sex steroid hormones in relation to Barrett's esophagus: an analysis of the FINBAR Study. Andrology. 2017;5(2):240-7. PMID: 28241109

Gu F, Zhang H, Hyland PL, Berndt S, Gapstur SM, Wheeler W, Ellipse Consortium T, Amos CI, Bezieau S, Bickeboller H, Brenner H, Brennan P, et al. Inherited variation in circadian rhythm genes and risks of prostate cancer and three other cancer sites in combined cancer consortia. Int J Cancer. 2017;141(9):1794-802. PMID: 28699174

Murphy G, McCormack V, Abedi-Ardekani B, Arnold M, Camargo MC, Dar NA, Dawsey SM, Etemadi A, Fitzgerald RC, Fleischer DE, Freedman ND, Goldstein AM, et al. International cancer seminars: a focus on esophageal squamous cell carcinoma. Ann Oncol. 2017;28(9):2086-93. PMID: 28911061

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