Publications

1. 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. Drafted 2013

2. P-H Hsyu*, DR Mould, R Upton, M Amantea. “A Population Pharmacokinetic Model of Bosutinib”. J Clin. Pharmacol. Drafted 2012

3. L Wu, DR Mould, J-J Perez Ruixo*, S Doshi. “Assessment of Hemoglobin Responsiveness to Epoetin alfa in Patients on Hemodialysis Using a Population Pharmacokinetic Pharmacodynamic Model”. J Clin Pharmacol Drafted 2012

4. 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” Drafted 2013

5. J.J. Perez-Ruixo*, S .Doshi, Y-M. Wang, D.R. Mould “A Semi-Mechanistic Model of Romiplostim for Stimulating Platelet Counts in Patients with Myelodysplastic Syndrome.” Br. J. Clin. Pharm. Accepted 2012

6. P-H Hsyu*, DR Mould, RN Upton, M Amantea. “Pharmacodynamic Analysis of Bosutinib in Patients With Chronic Phase Chronic Myelogenous Leukemia” Int J Cancer. Accepted 2012

7. J Ji, DR Mould, KA Blum, AS Ruppert, M Poi, Y Zhao, AJ Johnson, TS Lin, 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. In Press 2013

8. DR Mould* and 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. In Press 2013

9. 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.G. 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 Biologicals 40:517-527 2012

10. R 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

11. DR Mould*. “Model-Based Meta-Analysis: An Important Tool for Making Quantitative Decisions During Drug Development” Clin. Pharmacol. Ther. 92(3):283-286 2012

12. DR Mould. “Models for Disease Progression – New Approaches and Uses” Clin. Pharmacol. Ther. Submitted 2011

13. I Ordás, DR Mould, BG Feagan, WJ Sandborn. “Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetic Based Dosing Paradigms.” Clin. Pharmacol. Ther. Accepted 2011

14. A Parikh, T Leach, T Wyant, C Scholz, S Sankoh, DR Mould, T Ponic, I Fox, BG Feagan. “Vedolizumab for the Treatment of Active Ulcerative Colitis: A Randomized Controlled Phase 2 Dose-Ranging Study” Inflam. Bowel Diseases. Accepted 2011

15. J.J. Perez-Ruixo, B. Green, S. Doshi, Y-M. Wang, D.R. Mould. “Development of a Dosing Strategy for Romiplostin to treat patients with Immune (Idiopathic) Thrombocytopenic Purpura” J. Clin. Pharmacol. Accepted 2011

16. L. Jain, S. Woo, E. R. Gardner, D.R. Mould, W. L. Dahut, E. C. Kohn, S. Kummar, R. Yarchoan, G. Giaccone, J. Venitz, W.D. Figg. “Population pharmacokinetic analysis of sorafenib in patients with solid tumours.” Br J Clin Pharmacol 72(2):294-305 2011

17. 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

18. D. Karhu, G. Groenewoud, M Potgieter, D.R. Mould. “Dose Proportionality of Once-Daily Trazodone Extended Release Caplets Under Fasting Conditions” J Clin Pharm 50(12):1438-49 2010

19. D.R. Mould and B. Green “Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies: concepts and lessons for drug development” Biodrugs (2010) 24(1):23-39

20. O.A. O’Connor, P. Hamlin, C. Moskowitz, C. Portlock, D. Sarasohn; E. Neylon, J. Mastrella, R. Hamelers, B. Mac-Gregor-Cortelli, M. Paterson, A. D. Zelenetz, F. Sirotnak, M. Fleischer. D.R. Mould, M. Saunders, P. Cagnoni, S. Horwitz. “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

21. D.R. Mould, S.A. Molnar and T. Thomas “Modeling and Simulation as Tools to Improve Drug Development” Congressional Modeling and Simulation Website August 2009

22. DR Mould, K Sweeney, SB Duffull, E Neylon, P Hamlin, S Horwitz, F Sirotnak, M Fleisher, ME Saunders and OA O’Connor “A Population Pharmacokinetic and Pharmacodynamic Evaluation of Pralatrexate in Patients With Relapsed or Refractory Non-Hodgkin’s or Hodgkin’s Lymphoma” Clin. Pharmacol. Ther. (2009)

23. Elizabeth Y. Shang, Megan A. Gibbs, Jaren W. Landen, Michael Krams, Tanya Russell, Nicholas G. Denman, Diane R. Mould “Evaluation of Structural Models to Describe the Effect of Placebo upon the Time Course of Major Depressive Disorder” J Pharmacokinet Pharmacodyn (2009) 36:63-80

24. Feillet F, Clarke L, Meli C, Lipson M, Morris AA, Harmatz P, Mould DR, Green B, Dorenbaum A, Giovannini M, Foehr E; Sapropterin Research Group “Pharmacokinetics of Sapropterin in Patients with Phenylketonuria“ Clin Pharmacokinet. 47 (12):817-25 2008

25. WB. Smith, TC. Marbury, SF. Komjathy, M. Sumeray, DR Mould. “Pharmacokinetics and Pharmacodynamics of Clevidipine after Prolonged Continuous Infusion in Patients with Essential Hypertension.” Submitted 2008

26. 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

27. A. Roy, R. Raymond, D.R. Mould, X-F. Wang, L. Tay 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

28. O.A. O’Connor, P. Hamlin, C. Portlock, C. Moskowitz, A. Noy, D. Straus, B. MacGregor-Cortelli, E. Neylon, J. Pappanicolu, O. Dumetrescu, D.R. Mould, M. Fleischer, A.D. Zelenetz, 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

29. 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

30. 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

31. D.R. Mould and K.D 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

32. S.J. Tannenbaum, N.H.G. 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

33. 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

34. J Martin and D.R. Mould “Clinical Pharmacology: Drug Action in Progressing Disease” Eur J Hospital Pharm. Practice 2006 12(3):38-39

35. D.R. Mould, K. Nieforth, X. Zhang, M. Salgo, I. H. Patel “Population Pharmacokinetics of Enfuvirtide in Patients with Human Immunodeficiency Virus” Clin. Pharmacol. Ther. 2005 Jun;77(6):515-28

36. D.R. Mould, N.H.G. Holford, J.H.M. Schellens, J.H. Beijnen, P.R. Hutson, H. Rosing, W.W. ten Bokkel Huinink, EK Rowinsky, J.H. Schiller, M Russo, and G Dane MBChB “Pooled Pharmacokinetic and Adverse Event Analysis of Topotecan in Patients with Solid Tumors” Clin. Pharmacol. Ther. 2002 May;71(5):334-48

37. 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

38. S. Aktar, R.A. Beckman, D.R. Mould, S.Z. Fields, J. Wright “A Phase I Open Label Two Period Cross Over Study to Compare the Bioavailablility of a Single Dose of Oral Topotecan in the Presence or Absence or Ranitidine.” Cancer Chemother Pharmacol. 2000;46(3):204-10

39. 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 PRIMATIZED• 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

40. 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

41. 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 α-2a and a Poly(Ethylene Glycol) Modified Derivative in Healthy Subjects” Clin. Pharmacol. Ther., 59(6):636-646 1996

42. B. Fayer, 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

43. D.R. Mould, T.M. DeFeo, S.B. 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

44. 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.

45. 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.

46. 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.

47. 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.