Publications

Publications
  1. D.R. Mould, J.W. Duane* and E.L. Gross “Solid Modeling Used in Protein Design and Analysis”, ASEE Proc. Ann. Conference 2(1):1049-1053 1986.
  2. S.D. Black* and D.R. Mould “Calculation and Evaluation of Side-Chain Hydrophobicity for Physiological Amino Acids and Modified Derivatives”, Analytical Biochem.  193:72-82 1991.
  3. C. Anasetti*, M.-H. Binger, T. Waldmann, D. Mould, H. Satoh, F.R. Appelbaum, H.J. Deeg, K. Doney, P.J. Martin, R. Nash, R. Storb, K.M. Sullivan, R.P. Witherspoon and J.A. Hansen “Treatment of Acute Graft-Versus-Host Disease with a Humanized Monoclonal Antibody Specific for the IL-2 Receptor”, Blood Supplement  80(10):373-374A 1992.
  4. C. Anasetti*, J. Hansen, T. Waldmann, F. Appelbaum, J. Davis, J. Deeg, K. Dooney, P. Martin, R. Nash, R. Storb, K. Sullivan, R. Witherspoon, M. Binger, R. Chizzonite, J. Hakimi, D. Mould, H. Satoh, S. Light “Treatment of Acute GVHD with Humanized Anti TAC:  An Antibody That Binds to the Interleukin-2 Receptor” Blood  84(4):1320-1327 1994.
  5. D.R. Mould*, T.M. DeFeo, S. Reele G. Milla, R. Limjuco, T. Crews, N. Choma, and I.H. Patel “Simultaneous Modeling of the Pharmacokinetics and Pharmacodynamics of Midazolam and Diazepam”  Clin. Pharmacol. Ther., 58(1):35-43 1995
  6. B.E. Fayer*, P.P. Soni, M.H. Binger, D.R. Mould and H. Satoh  “Determination of Humanized Anti-TAC in Human Serum by a Sandwich Enzyme Linked Immunosorbent Assay” J. Immunological Methods  186:47-54 1995
  7. K.A. Nieforth*, R. Nadeau, I.H. Patel and D.R. Mould “Use of an Indirect Pharmacodynamic Stimulation Model to Compare In Vitro Activity of Interferon a-2a and a Poly(Ethylene Glycol) Modified Derivative in Healthy Subjects” Clin. Pharmacol. Ther., 59(6):636-646 1996
  8. F. Vincenti*, M. Lantz, J. Birnbaum, M. Garovoy, D. Mould, J. Hakimi K. Nieforth and S. Light “A Phase I Trial of Humanized Anti Interleukin-2 Receptor Antibody in Renal Transplantation”.  Transplantation 63(1) 1-5:1997
  9. D.R. Mould*, C.B. Davis, E.A. Minthorn, D.C. Kwok, M.J. Eliott, M.E. Luggen, and M.C. Totoritis  “Population Pharmacokinetic/Pharmacodynamic Analysis of the Effects of Clenoliximab, a PRIMATIZEDÔ anti-CD4 monoclonal antibody, on T lymphocytes, following single doses to patients with active rheumatoid arthritis.”  Clin. Pharmacol. Ther., 1999 Sep;66(3):246-57
  10. S. Akhtar, R.A. Beckman*, D.R. Mould, E. Doyle, S.Z. Fields, J. Wright  “A Phase I Open Label Two Period Cross Over Study to Compare the Bioavailability of a Single Dose of Oral Topotecan in the Presence or Absence or Ranitidine.”  Cancer Chemother Pharmacol. 2000;46(3):204-10
  11. D.R. Mould*, J.B. Aluri, M.C. Chapelsky, J.G. Granett, R. Samuels “A Population Pharmacokinetic Pharmacodynamic and Logistic Regression Analysis of Lotrafiban”  Clin Pharmacol Ther 2001 69(4):209-222
  12. D.R. Mould*, N.H. Holford, J.H. Schellens, J.H. Beijnen, P.R. Hutson, H. Rosing, W.W. ten Bokkel Huinink, E.K. Rowinsky, J.H. Schiller, M. Russo, and G. Ross “Pooled Pharmacokinetic and Adverse Event Analysis of Topotecan in Patients with Solid Tumors”  Clin. Pharmacol. Ther.  2002 71(5):334-48
  13. D.R. Mould, X. Zhang, K. Nieforth, M. Salgo, N. Buss I. H. Patel* “Population Pharmacokinetics of Enfuvirtide in Patients with Human Immunodeficiency Virus” Clin. Pharmacol. Ther.  2005 Jun;77(6):515-28
  14. J Martin* and D.R. Mould “Clinical Pharmacology: Drug Action in Progressing Disease” Eur J Hospital Pharm. Practice 2006 12(3):38-39
  15. D.R Mould, G.F. Fleming, K.M. Darcy, and D. Spriggs* “Population Analysis of a 24-hour Paclitaxel Infusion in Advanced Endometrial Cancer: A Gynecologic Oncology Group Study” British J. Clin. Pharmacol. 2006 62(1):56-70
  16. S.J. Tannenbaum*, N.H. Holford, H. Lee, C.C. Peck, and D.R. Mould “A Method for Simulation of Correlated Continuous and Categorical Variables using a Single Multivariate Distribution” J. Pharmacokin. Pharmacodyn. 2006 33(6):773-94
  17. D.R. Mould* and K.R Sweeney “A Review of the Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies – Mechanistic Modeling Applied to Drug Development” Current Opinion in Drug Discov. and Devel. 2007 10(1): 84-96
  18. D.R. Mould*, N.G. Denman, S. Duffull “Using Disease Progression Models as a Tool to Detect Drug Effect”  Clin. Pharmacol. Ther.   82(1):81-86 2007
  19. D.R. Mould, A. Baumann, J. Kuhlmann, M.J. Keating, S. Weitman, P. Hillmen, L.R. Brettman, S. Reif, and P.L. Bonate* “Population Pharmacokinetics-Pharmacodynamics of Alemtuzumab (Campath®) in Patients with Chronic Lymphocytic Leukemia”  British J. Clin. Pharmacol. 64(3):278-291 2007
  20. O.A. O’Connor*, P.A. Hamlin, C. Portlock, C.H. Moskowitz, A. Noy, D.J. Straus, B. Macgregor-Cortelli, E. Neylon, D. Sarasohn, O. Dumetrescu, D.R. Mould, M. Fleischer,  A.D. Zelenetz, F. Sirotnak, S. Horwitz  “Pralatrexate, A Novel Class of Antifolate with High Affinity for the Reduced Folate Carrier-Type 1,  Produces Marked Complete and Durable Remissions in a Diversity of Chemotherapy Refractory Cases of T-cell Lymphoma”  British J. Haematol. 139(3):425-8 2007
  21. A. Roy*, D.R. Mould, X-F. Wang, L. Tay, R. Raymond, and M. Pfister “Modeling and Simulation of Abatacept Exposure and Interleukin-6 Response in Support of Recommended Doses for Rheumatoid Arthritis”  J Clin Pharmacol 47: 1408-1420 2007
  22. C. Cronenberger, D.R. Mould, H-J. Roethig, and M. Sarkar* “Population Pharmacokinetic Analysis of Carboxyhemoglobin Levels in Adult Cigarette Smokers.”  British J. Clin. Pharmacol. 65 (1):30-39 2008
  23. F. Feillet*, L. Clarke, C. Meli, M. Lipson, A.A. Morris, P. Harmatz, D.R. Mould, B. Green, A Dorenbaum, M Giovannini and E. Foehr  for the Sapropterin Research Group “Pharmacokinetics of Sapropterin Dihydrochloride in Patients with Phenylketonuria”   Clin Pharmacokinet. 47(12):817-825 2008
  24. E.Y. Shang*, M.A. Gibbs, J.W. Landen, M Krams, T. Russell, N.G. Denman, D.R. Mould “Evaluation of Structural Models to Describe the Effect of Placebo upon the Time Course of Major Depressive Disorder” J Pharmacokin Pharmacodyn. 36:63-80 2009
  25. D.R. Mould*, K. Sweeney, S. Duffull, E. Neylon, P. Hamlin, S. Horwitz, F. Sirotnak, M. Fleisher, M.E. Saunders, and O.A. O’Connor. “A Population Pharmacokinetic And Pharmacodynamic Evaluation of Pralatrexate”  Clin Pharmacol Ther 86(2):190-6 2009
  26. O.A. O’Connor*, S. Horwitz,  P. Hamlin, C. Portlock, CH Moskowitz, D. Sarasohn; E. Neylon, J. Mastrella, R. Hamelers, B. Macgregor-Cortelli, M. Patterson, VE Seshan, F. Sirotnak, M. Fleisher. D.R. Mould, M. Saunders, A. D. Zelenetz, “A Phase ‘2-1-2’ Study of Two Different Doses and Schedules of Pralatrexate, a High Affinity Substrate for the Reduced Folate Carrier (RFC-1), in Patients with Relapsed or Refractory Lymphoma Reveals Marked Activity in T-cell Malignancies” J Clin Oncol 27(26):4357-4364 2009
  27. D.R. Mould*, B. Green “Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies: Concepts and Lessons for Drug Development” BioDrugs 24(1):23-39 2010
  28. D. Karhu*, G. Groenewoud, MA Potgieter, D.R. Mould.  “Dose Proportionality of Once-Daily Trazodone Extended Release Caplets Under Fasting Conditions” J Clin Pharmacol  50(12):1438-49 2010
  29. D.R. Mould* and B. Frame “Population Pharmacokinetic-Pharmacodynamic Modeling of Biological Agents: When Modeling Meets Reality” J Clin Pharmacol 50(9 Suppl):91S-100S 2010
  30. L. Jain, S. Woo, E. R. Gardner, W. L. Dahut,  E. C. Kohn, S. Kummar, D.R. Mould, G. Giaccone, R. Yarchoan, J. Venitz, W.D. Figg*.  “Population Pharmacokinetic Analysis of Sorafenib in Patients with Solid Tumours.” Br J Clin Pharm  72(2):294-305 2011
  31. A Parikh, T Leach, T Wyant, C Scholz, S Sankoh, DR. Mould, T Ponich, I Fox, BG. Feagan* “Vedolizumab for the Treatment of Active Ulcerative Colitis: A Randomized Controlled Phase 2 Dose-Ranging Study”.  Inflam. Bowel Diseases. 18(8):1470-9 2012
  32. I Ordás, DR Mould, BG Feagan, WJ Sandborn*. “Anti-TNF Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetic Based Dosing Paradigms.”  Clin. Pharmacol. Ther. 91(4):635-46 2012
  33. J.J. Perez-Ruixo*, B. Green, S .Doshi, Y-M. Wang, D.R. Mould “Development of a Dosing Strategy for Romiplostim to treat patients with Immune (Idiopathic) Thrombocytopenic Purpura”.  J. Clin. Pharmacol.  52:(10):1540-1551 2012
  34. WB Smith, TC Marbury, SF Komjathy, MS Sumeray, GC Williams*, M-Y Hu, DR Mould.  “Pharmacokinetics, Pharmacodynamics and Safety of Clevidipine after Prolonged Continuous Infusion in Subjects with Mild to Moderate Essential Hypertension” Eur J Clin Pharm 68(10):1385-94 2012
  35. DR Mould* “Models for Disease Progression – New Approaches and Uses”.  Clin. Pharmacol. Ther. 92(1):125-131 2012
  36. DR Mould*. “Model-Based Meta-Analysis:  An Important Tool for Making Quantitative Decisions During Drug Development”  Clin. Pharmacol. Ther. 92(3):283-286 2012
  37. DR Mould* and RN Upton “Basic Concepts in Population Modeling, Simulation and Model-Based Drug Development” Clin. Pharmacol. Ther. Pharmacomet. and Systems Pharmacol. 1, e6  2012
  38. J Kay,*, B.G. Feagan, M.S. Guirguis, E. C. Keystone, A. V. Klein, A. S. Lubiniecki, D. R. Mould, K. A. Nyarko, A. A Ridgway, M. E. Trudeau, J. Wang. “Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.” Biologicals 40:517-527 2012
  39. J Ji, DR Mould, KA Blum, AS Ruppert, M Poi, Y Zhao, AJ Johnson, JC Byrd, MR Grever, MA Phelps*. “Population Modeling for Flavopiridol and its Primary Glucuronide Metabolite in association with Tumor Lysis Syndrome in patients with Chronic Lymphocytic Leukemia.” Cancer Chemother. Res. 19(5):1269-80 2013
  40. DR Mould*, RN Upton “Basic Concepts in Population Modeling, Simulation and Model-Based Drug Development – Part 2:  Introduction to Pharmacokinetic Modeling Methods” Clin. Pharmacol. Ther. Pharmacomet. and Systems Pharmacol. 2, e38 2013
  41. JJ Perez-Ruixo*, S .Doshi, YM. Wang, DR  Mould “A Semi-Mechanistic Model of Romiplostim for Stimulating Platelet Counts in Patients with Myelodysplastic Syndrome.” Br. J. Clin. Pharm. 2013;75(6):1445-54
  42. I Mikaelian*, ME. Dunn, DR Mould, G Hirkaler, W Geng, D Coluccio, R Nicklaus, T Singer, M Reddy. “Time-dependent Serum Cardiac Troponin I Concentration Increases in Rats Subjected to Simulated Tail Venipuncture”  Pharmacol. Res. and Perspect. 1(2):1-12 2013
  43. P-H Hsyu*, DR Mould, R Upton, M Amantea. “Pharmacokinetic-pharmacodynamic relationship of bosutinib in patients with chronic phase chronic myeloid leukemia”.  .Cancer Chemother Pharmacol. 2013;71(1):209-18
  44. Mould DR*, Moyer B, Amur S, Mukherjee A.  “The Impact of New Technologies on the Science of Clinical Care and Drug Development”.  AAPS Magazine December 2013
  45. RN Upton*, Mould DR. “Basic Concepts in Population Modeling, Simulation and Model-Based Drug Development – Part 3:  Introduction to Pharmacodynamic Modeling Methods” Clin. Pharmacol. Ther. Pharmacomet. and Systems Pharmacol. (2014) 3, e88; doi:10.1038/psp.2013.71
  46. Q Zhao*, TG Tensfeldt, R Chandra, DR Mould. “Population Pharmacokinetics of Azithromycin and Chloroquine in Healthy Adults and Pediatric Malaria Subjects Following Oral Administration of Fixed Dose Azithromycin and Chloroquine Combination Tablets” Malaria. 2014;13:36
  47. P Liu*, DR Mould. “Population Pharmacokinetic Analysis of Voriconazole and Anidulafungin in Adult Patients with Invasive Aspergillosis” Antimicrob. Agent Chemother. 2014;58(8):4718-4726
  48. P Liu*, DR Mould. “Population Pharmacokinetic-Pharmacodynamic Analysis of Voriconazole and Anidulafungin in Adult Patients with Invasive Aspergillosis” Antimicrob. Agent Chemother. 2014;58(8):4727-4736
  49. Ghosh S*, Pariente B, Mould DR, Schreibern S, Petersson J, Hommes D. “New tools and approaches for improved management of inflammatory bowel disease” J. Crohns and Colitis 2014;8(10):1246-53
  50. Mould DR*, Upton R, Wojciechowski J. “Dashboard Systems: Implementing Pharmacometrics from Bench to Bedside”.  AAPS J 2014;16(5):925-3
  51. I Dotan*, Y Ron, H Yanai, S Becker, S Fishman, L Yahav, M Ben Yehoyada, DR Mould. “Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease. A population pharmacokinetic study”  Inflamm Bowel Dis. 2014 Dec;20(12):2247-59
  52. Qi Y, Mould DR, Zhou H, Merilainen M, Musson DG*. “A Prospective Population Pharmacokinetic Analysis of Sapropterin Dihydrochloride in Infants and Young Children with Phenylketonuria” Clin. Pharmacokin. 2015 Feb;54(2):195-207
  53. Venkatakrishnan K*, Zhou X, Ecsedy J, Mould DR, Liu H, Danaee H, Fingert H,  Kleinfield R, Milton A. “Clinical pharmacologic considerations for the phase 2/3 dose/regimen of the investigational Aurora A kinase (AAK) inhibitor MLN8237 (alisertib): pharmacokinetics, pharmacodynamics, and exposure-safety relationships” Brit J Clin Pharm  Epub October 2014
  54. Venkatakrishnan K*, Friberg LE, Ouellet D, Mettetal J, Stein A, Trocóniz I, Bruno R, Mehrotra N, Gobburu J, Mould DR*. “Optimizing Oncology Therapeutics through Quantitative Clinical Pharmacology: Challenges and Opportunities” Clin Pharmacol Ther.  2015;97(1):37-54
  55. Mould DR*, Walz A, Lave T, Gibbs J, Frame B.  “Developing Exposure/Response Models for Anti-Cancer Drug Treatment:  Special Considerations” Clin Pharmacol Ther: Syst Pharmacol Epub Jan 2015.
  56. Hsyu PH*, Mould DR, Abbas R, Amantea M. “Population Pharmacokinetic and Pharmacodynamic Analysis of Bosutinib.” Drug Metab Pharmacokinet. 2014 25;29(6):441-8
  57. Mould DR*, Dubinsky MC. “Dashboard Systems: Pharmacokinetic / Pharmacodynamic Mediated Dose Optimization.”  J Clin Pharmacol. 2015;55 Suppl 3:S51-9
  58. Kimko H*, Thyssen A, Mould DR, Mannaert E, Treem W.  “Helicobacter pylori Treatment in Children: Defining a Dose and Dosing Regimen for Rabeprazole” Ped. Neonat. Care 2015;55(5):592-600
  59. Wu L, Mould DR, Perez Ruixo JJ, Doshi S*. “Assessment of Hemoglobin Responsiveness to Epoetin alfa in Patients on Hemodialysis Using a Population Pharmacokinetic Pharmacodynamic Model.” J. Clin. Pharmacol. 2015; 55(10):1157-66
  60. Mould DR*. “The pharmacokinetics of biologics a primer.” Digestive Diseases 2015;33(suppl 1):61–69
  61. Mould DR* Commentary: “Why Therapeutic Drug Monitoring is Needed for Monoclonal Antibodies and How Do We Implement This?” Clin Pharmacol Ther. 2016;99(4):351-4
  62. Mould DR*, D’Haens G, Upton RN. “Clinical Decision Support Tools:  The Evolution of a Revolution.”  Clin Pharmacol Ther. 2016;99(4):405-18
  63. Mould DR*, Meibohm B. :Drug Development of Therapeutic Monoclonal Antibodies.”  BioDrugs 2016;30(4):275-93
  64. Melmed GY*, Irving PM, Jones J, Kaplan GG, Kozuch PL, Velayos FS, Baidoo L, Sparrow MP, Bressler B, Cheifetz AS, Devlin SM, Raffals LE, Vande Casteelle N, Mould DR, Colombel J-F, Dubinsky M, Sandborn WJ, Siegel CA. “Appropriateness of Testing and Interpretation of anti-TNF Drug and Antibody Concentrations: When should they be ordered, and what to do with the results?” Clin Gastroenterol Hepatol. 2016 ;14(9):1302-9
  65. Garrett M, Taylor T, Mould DR, Amantea MA, Chen Y, Ingrosso A, Pithavala YK*. “Lack of effect of smoking on axitinib pharmacokinetics in non-small cell lung cancer patients.” Br J Clin Pharmacol 2016;78(6):1131-1141
  66. Chan P*, Mould DR, Abu Tarif M, Reynolds L, LaCreta F, Bertz R,  Bifano M. “Using Population Pharmacokinetic and Pharmacodynamic Analyses of Entecavir in Pediatric Subjects to Simplify Dosing Recommendations.” Clin Pharmacokinet.  2016 Dec;55(12):1559-1572
  67. Pushkin R*, Iglesias-Ussel M, Darouiche R, Stolarski E, Berkowitz R, Kreuzer H, MacLauchlin C, Mould DR, Oldach D, Fernandez P. A Randomized Study “Evaluating Oral Fusidic Acid (CEM 102) in Combination with Oral Rifampin Compared with Standard of Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction.” Clin Infect Dis 2016 15;63(12):1599-1604
  68. Muntau AC*, Burlina A; Eyskens F, Freisinger P, De Laet C, Leuzzi V, Rutsch F, Sivri HS; Vijay S, Orquidea Bal M, Gramer G, Pazdírková R, Cleary M, Lotz-Havla AS; Munafo A, Mould DR; Moreau-Stucker  F, Rogoff D. “Efficacy, safety and population pharmacokinetics of sapropterin in PKU patients <4 years: results from the SPARK trial.” Orphanet Journal of Rare Diseases. 1:47-58 2017
  69. Dubinsky MC*, Phan BL, Singh N, Rabizadeh S, Mould DR. “Pharmacokinetic dashboard recommended dosing is different than standard of care dosing in infliximab treated pediatric IBD patients.” AAPS J. 2017 ;19(1):215-222
  70. Nguyen THT, Mouksassi S, Comets E, Freedman I, Hooker A, Holford NHG, Jyothy J, Karlsson MO, Mould DR, Pérez Ruixo J, Plan EL, Savic R, van Hasselt JCG, Weber B, Zhou C, Mentré F*. “Model evaluation of continuous data pharmacometric models: metrics and graphics.”  CPT:PSP 2017;6(2):87-109
  71. Brandse JF*,  Mould DR, Ashruf YK, Smeekes OS, Kuin S, van den Brink GR,  D’Haens GR. “A Real-life Population Pharmacokinetic Study Reveals Factors Associated with Clearance and Immunogenicity of Infliximab in Inflammatory Bowel Disease.” Inflam Bowel Dis. 2017 ;23(4):650-660
  72. Nijenhuis CM*, Lucas L, Rosing H, Huitema AD, Mergui-Roelvink M, Jamieson GC, Fox JA, Mould DR, Schellens JH, Beijnen JH. “Metabolism and disposition of the anticancer quinolone derivative vosaroxin, a novel inhibitor of topoisomerase II.” Invest New Drugs. 2017 Aug;35(4):478-490
  73. Jacobs FMJ*, Mould DR. “The role of FcRn in the pharmacokinetics of biologics in patients with multiple myeloma.”  Letter. Clin. Pharmacol. Ther. 2017;102(6):903-904
  74. Hanley MJ*, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. “Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range.” J Clin Pharmacol. 2017;57(9):1183-1193
  75. Wojciechowski J*, Upton RN, Mould DR, Wiese MD, Foster DJR. “Infliximab Maintenance Dosing in Inflammatory Bowel Disease: an Example for In Silico Assessment of Adaptive Dosing Strategies.” AAPS J. 2017;19(4):1136-1147.
  76. Vande Casteele N*ould DR, Coarse J, Hasan I, Gils A, Feagan B, Sandborn WJ. “Accounting for Pharmacokinetic Variability of Certolizumab Pegol in Patients with Crohn’s Disease.” Clin Pharmacokinet. 2017; 56(12):1513-1523
  77. Mould DR*, Hutson PR. “Critical Considerations in Anticancer Drug Development and Dosing Strategies: The Past, Present and Future.” J Clin Pharmacol. 2017;57 Suppl 10:S116-S128
  78. Zhou X*, Mould DR, Takubo T, Sheldon-Waniga E, Huebner D, Milton A, Venkatakrishnan K*. “Global population pharmacokinetics of the investigational Aurora A kinase inhibitor alisertib in cancer patients: Rationale for lower dosage in Asia” Br. J Clin Pharmacol. 2018; 84(1):35-51
  79. Zhou X*  Nemunaitis J, Pant S,  Bauer TM, Patel M, Sarantopoulos J,Lockhart AC, Goodman D, Huebner D, Mould DR, Venkatakrishnan K. “Effect of alisertib, an investigational Aurora A kinase inhibitor on the QTc interval in patients with advanced malignancies.” Invest. New Drugs 2018; 36(2):240-247
  80. Anderson CM*, Allen BG, Sun W, Agarwala SS, Lee CM, Venigalla ML, Greenberg L, Adkins D, Chen Y, Zhen W, Mould DR, Holmlund J, Brill J, Sonis ST, Buatti J. Phase 1b/2a “Trial of Superoxide Dismutase Mimetic GC4419 to Reduce Chemoradiotherapy-induced Oral Mucositis in Patients with Oral Cavity or Oropharyngeal Carcinoma” Int J Radiation Oncology*Biology*Physics. 2018;100(2):427-435
  81. Mulugeta L Y*, Mould DR, Jacobs B, Florian J, Smith PB, Sinha V, Barrett J. “Leveraging Big Data in Pediatric Development Programs: Proceedings from the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.” Clin Pharmacol Ther. 2018; 104(1):81-87
  82. Eser A, Primas C, Vogelsang H, Novacek G, Mikulits A, Reinisch S,  Papay P, Lichtenberger C, Brehovsky S, Mould DR, Reinisch W*. “Prediction of individual serum infliximab concentrations in inflammatory bowel disease by a Bayesian dashboard system.”  J Clin Pharmacol 2018; 58(6):790-802
  83. Kevans D*, Murthy S, Mould DR, Silverberg MS. “Accelerated Clearance of Infliximab is Associated with Treatment Failure in Patients with Corticosteroid Refractory Acute Ulcerative Colitis.” J Crohns Colitis.  2018; 12(6):662-669
  84. Priestley T,* Chappa A, Mould DR, Upton RN,  Shusterman N, Passik S, Tormo V, Camper S. “Converting From Transdermal to Buccal Formulations of Buprenorphine: A Pharmacokinetic Meta-Model Simulation in Healthy Volunteers.” Pain Medicine 2018; 19(10):1988-1996
  85. Mould DR*, Upton RN, Wojciechowski J, Phan BL, Tse S, Dubinsky MC. “Dashboards For Therapeutic Monoclonal Antibodies: Learning and Confirming.”  AAPS J 2018;20(4):76 [epub]
  86. Strik AS, Wang Y-M C, Ruff L, Yashar W, Messmer B, Mould DR. “Individualized Dosing of Therapeutic Monoclonal Antibodies – A Changing Treatment Paradigm” AAPS J 2018; 20(6):99 [epub]
  87. Mukherjee A*, Hazra A, Smith M, Martin S, Mould Dr,  Su C, Niezychowski W. “Exposure-response characterization of tofacitinib efficacy in moderate to severe ulcerative colitis: Results from a dose-ranging phase 2 trial.” Br J Clin Pharmacol.  2018;84(6):1136-1145
  88. Cho Y-K, Irby D, Li J, Sborov D, Mould DR, Badawi M, Dauki A, Lamprecht M, Rosko A, Fernandez S, Hade E, Hofmeister C, Poi M, Phelps M*. “Pharmacokinetic-Pharmacodynamic Model of Neutropenia in Myeloma Patients Receiving High-Dose Melphalan for Autologous Stem Cell Transplant.” Clin Pharmacol Ther Syst Pharmacol. 2018 Nov;7(11):748-758
  89. Suri A*, Mould DR, Liu Y, Jang G, Venkatakrishnan K. “Population PK and Exposure–Response Relationships for the Antibody-Drug Conjugate Brentuximab Vedotin in CTCL patients in the Phase III ALCANZA study” Clin Pharmacol Ther.  2018;104(5):989-999
  90. Turner D*, Griffiths A, Wilson DC, Mould DR, Baldassano R, Russell RK, Dubinsky MC, Heyman MB, de Ridder L, Hyams JS, Martín-de-Carpi J, Conklin LS, Faubion WA, Koletzko S, Bousvaros A, Ruemmele FM. “Designing clinical trials in pediatric inflammatory bowel diseases – a PIBDnet commentary.” GUT 2019; epub.
  91. Suri A*, Mould DR, Song G, Collins GP, Endres CJ, Gomez-Navarro J, Venkatakrishnan K. “Population Pharmacokinetic Modeling and Exposure-Response Assessment for the Antibody-Drug Conjugate Brentuximab Vedotin in Hodgkin Lymphoma in the Phase 3 ECHELON-1 study.” Clin Pharmacol Ther. 2019; 106(6):1268-1279
  92. Garner RM, Mould DR, Chieffo C, Jorkasky DK*. “Pharmacokinetic and Pharmacodynamic Effects of Oral CXA-10, a Nitro-Fatty Acid, After Single and Multiple Ascending Doses in Healthy and Obese Subjects.” Clin Translational Sci 2019;12(6):667-676.
  93. Faessel HM*, Mould DR, Zhou X, Faller DV, Sedarati F, Venkatakrishnan K. “Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies.” Br J Clin Pharmacol. 2019;85(11):2568-2579
  94. Vinks AA, Peck RW, Neely M, Mould DR. “Bedside precision dosing 2030 – Development and implementation of electronic health record integrated clinical decision support tools for the precision dosing of drugs.” Clin Pharmacol Ther. 2020; 107(1):129-135
  95. Mukai M,  Maeda H Narushima K, Mould DR Greene D. “Population Pharmacokinetic Modeling of Mogamulizumab in Adults with Cutaneous T-cell Lymphoma or Adult T-cell Lymphoma.” J Clin Pharmacol. 2020;60(1):58-66
  96. Mukai M, Mould DR Maeda H, Narushima K, Greene D. “Exposure-Response Analysis for Mogamulizumab in Adults with Cutaneous T-cell Lymphoma.” J Clin Pharmacol. 2020;60(1):50-57
  97. Oketch-Rabah HA, Hardy ML,Patton AP, Chung M, Sarma ND, Yoe C, Shiva Ayyadurai VA, Fox MA, Jordan SA, Mwamburi M, Mould DR, Osterberg RE, Hilmas C, Tiwari R, Valerio L Jr., Jones D,  PA Giancaspro GI. “Multi-Criteria Decision Analysis Model for Assessing the Risk from Multi-Ingredient Dietary Supplements (MIDS).” J Dietary Suppl. Published online: 22 Apr 2020
  98. Gerds AT, Savona MR, Scott BL; Talpaz M, Egyed M, Harrison CN, Yacoub A; Vannucchi A, Mead AJ, Kiladjian J-J, O’Sullivan J, García-Gutiérrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Sirin A. Kahrs18; Devineni S, Craig AR, Mascarenhas JO. “Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis.” Blood Adv. 2020;4(22):5825-5835.
  99. Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. “Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients with Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens” J Clin Pharm J Clin Pharmacol. 2020;60(12):1585-1597
  100. Dave MB, Dherai AJ, Desai DC, Mould DR, Ashavaid TF. “Optimization of Infliximab therapy in Inflammatory Bowel disease using a Dashboard approach – An Indian experience” Eur J Clin Pharmacol 2021;77(1):55-62
  101. Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021;61(2):224-233.
  102. Strik AS*, Löwenberg M, Mould DR, Berends SE, CI Ponsioen CI, van den Brande J, Jansen JM, Hoekman DR, Brandse JF, Mathôt RA, D’Haen GR. Dashboard driven versus conventional dosing of infliximab in inflammatory bowel disease patients: the PRECISION trial. Scand J Gastroenterol. 2021;56(2):145-154.
  103. Pariser DM*, Lain EL, Mamelok R, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis  Clin Pharmacokinet 2021;60(5):665-676
  104. Irby DJ, Ibrahim ME, Dauki AM, Badawi MA, Illamola SM, Chen M, Wang Y, Liu X, Phelps MA, Mould DR. Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics. CPT Pharmacometrics Syst Pharmacol. 2021 Apr;10(4):291-308
  105. Zhou X, Mould DR, Yuan Y, Weigel B, Fox E, Greengard E, Faller DV, Venkatakrishnan K. Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies J. Clin. Pharmacol. 2022;62(2):206-219.
  106. Dubinsky MC*, Phan BL, Tse SS, Mould DR. “Dashboard-Driven Accelerated Infliximab Induction Dosing Increases Infliximab Durability and Reduces Immunogenicity.” IBD J. 2022 ;28(9):1375-1385
  107. Primas C, Reinisch W, Panetta JC, Eser A, Mould DR, Dervieux T. “Model Informed Precision Dosing Tool Forecasts Trough Infliximab and Associates with Disease Status and Tumor Necrosis Factor α Levels of Inflammatory Bowel Diseases” J. Clin. Med . 2022 ;11(12):3316.
  108. Desai DC, Dherai AJ, Strik A, Mould DR. Personalized dosing of infliximab in patients with Inflammatory Bowel Disease using a Bayesian approach: a next step in therapeutic drug monitoring.  J. Clin Pharmacol. epub 2022
  109. Zhou X, Richardson DL, Dowlati A, Goel S, Sahebjam S, Strauss J, Chawla S, Wang S, Mould DR, Samnotra V, Faller DV, Venkatakrishnan K, Gupta N. Effect of Pevonedistat, an Investigational NEDD8-Activating Enzyme Inhibitor, on the QTc Interval in Patients With Advanced Solid Tumors. Clin Pharmacol. Drug Dev. 2023;12(3):257-266
  110. Atia O, Shavit-Brunschwig Z, Mould DR, Stein R, Matar M, Aloi M, Ledder O, Focht G, Urlep D, Hyams J, Broide E, Weiss B, Levine J, Russell RK, Turner D. Outcomes, dosing, and predictors of vedolizumab treatment in children: results from the prospective, multicenter VEDOKIDS cohort. Lancet Gastro 2023 ;8(1):31-42
  111. Milenkovic-Grisic A-M, Terranova N, Mould DR, Vugmeyster Y, Mrowiec T, Machl A, Girard P. Venkatakrishnan K, Khandelwal A. Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non-small cell lung cancer based on bintrafusp alfa trials.  Clin Pharmacol Ther-Pharmacom Syst Pharmacol accepted 2023
  112. Nguyen, A, Upton R. Mould DR. Sparrow M. Application of an Algorithm-based Precision-dosing Model to a Real World Cohort of Patients on Infliximab Maintenance Therapy: Implications for Drug Usage and Cost. J Clin Pharmacol Accepted 2023
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