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  1. Center for Drug Evaluation and Research | CDER

Division of Applied Regulatory Science - Recent Publications

Division of Applied Regulatory Science Overview

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


Bioinformatics, Cheminformatics, and Systems Pharmacology

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

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, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, 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

Yu LR, Cao Z, Makhoul I, Daniels JR, Klimberg S, Wei JY, Bai JP, Li J, Lathrop JT, Beger RD, Todorova VK. 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

Animal Models

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: 29699496

Matta MK, Beekman CR, Gandhi A, Narayanasamy S, Thomas CD, Mohammad A, Stewart S, Xu L, Chockalingam A, Shea K, Patel V, Rouse R. 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

Pharmacokinetics and Clinical Pharmacology

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

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

Sun D, Rouse R, Patel V, Wu Y, Zheng J, Karmakar A, Patri AK, Chitranshi P, Keire D, Ma J, Jiang W. 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, Balimane PV. Application of in vitro CYP and transporter assays to predict clinical drug-drug interactions. Bioanalysis. 2018;10(9):619-23. PMID: 29768028

Cardiac Safety

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

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

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: 29651591

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

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

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


Pine PS, Lund SP, Parsons JR, Vang LK, Mahabal AA, Cinquini L, Kelly SC, Kincaid H, Crichton DJ, Spira A, Liu G, Gower AC, et al. Summarizing performance for genome scale measurement of miRNA: reference samples and metrics. BMC Genomics. 2018;19(1):180. PMID: 29510677


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


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