Publications

Selected Publications on Modeling and Simulation

1. J.W.Mandema, M. Gibbs, R.A. Boyd, D.R. Wada, and M. Pfister. 2011. Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond. Clin Pharmacol Ther. 90(6):766-9. Abstract

2. J.W. Mandema, R.A. RA, and L.A. Dicarlo. 2011. Therapeutic index of anticoagulants for prevention of venous thromboembolism following orthopedic surgery: a dose-response meta-analysis. Clin Pharmacol Ther. 90(6):820-7. Abstract

3. J.W. Mandema, D.H. Salinger, S.W. Baumgartner, and M.A. Gibbs. 2011. A dose-response meta-analysis for quantifying relative efficacy of biologics in rheumatoid arthritis. Clin Pharmacol Ther. 90(6):828-35. Abstract

4. H.M. Dobrovolny, R. Gieschke, B.E. Davies, N.L. Jumbe, and C.A. Beauchemin. 2011. Neuraminidase inhibitors for treatment of human and avian strain influenza: A comparative modeling study. J Theor Biol. 269(1):234-44. Abstract

5. E. Snoeck, P. Chanu, M. Lavielle, P. Jacqmin, E.N. Jonsson, K. Jorga K, T. Goggin, J. Grippo, N.L. Jumbe, and N. Frey. 2010. A comprehensive hepatitis C viral kinetic model explaining cure. Clin Pharmacol Ther. 87(6):706-13. Abstract

6. H.M. Dobrovolny, M.J. Baron, R. Gieschke R, B.E. Davies, N.L. Jumbe, and C.A. Beauchemin. 2010. Exploring cell tropism as a possible contributor to influenza infection severity. PLoS One. 5(11):e13811. PDF

7. S. Rohatagi, H. Kastrissios, K. Sasahara, K. Truitt, J.B. Moberly, R. Wada, and D.E. Salazar. 2008. Pain relief model for a COX-2 inhibitor in patients with postoperative dental pain. Br J Clin Pharmacol. 66:60-70. PDF

8. W.S. Putnam, J. Li, J. Haggstrom, C. Ng, S. Kadkhodayan-Fischer, M. Cheu, Y. Deniz, H. Lowman, P. Fielder, J. Visich, A. Joshi, and N.S. Jumbe. 2008. Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody. AAPS J. 10(2):425-30. PDF

9. S. Rohatagi, H. Kastrissios, Y. Gao, N. Zhang, J. Xu, J. Moberly, R. Wada, K. Yoshihara, M. Takahashi, K. Truitt, and D. Salazar. 2007. Predictive population pharmacokinetic/pharmacodynamic model for a novel COX-2 inhibitor. J Clin Pharmacol. 47:358-70. Abstract

10. H. J. Lemmens, D.R. Wada, C. Munera, A. Eltahtawy, and D.R. Stanski. 2006. Enriched analgesic efficacy studies: an assessment by clinical trial simulation. Contemp Clin Trials. 27:165-73. Abstract

11. H. Kastrissios, S. Rohatagi, J. Moberly, K. Truitt, Y. Gao, R. Wada, M. Takahashi, K. Kawabata, and D. Salazar. 2006. Development of a predictive pharmacokinetic model for a novel cyclooxygenase-2 inhibitor. J Clin Pharmacol. 46:537-48. Abstract

12. J.W. Mandema, D. Hermann, W. Wang, T. Sheiner, M. Milad, R. Bakker-Arkema, and D. Hartman. 2005. Model-based development of gemcabene, a new lipid-altering agent. Aaps J. 7:E513-22. PDF

13. J.W. Mandema, Cox E, Alderman J. 2005. Therapeutic benefit of eletriptan compared to sumatriptan for the acute relief of migraine pain–results of a model-based meta-analysis that accounts for encapsulation. Cephalalgia. 2005 Sep;25(9):715-25. Abstract

14. K. Yoshihara, Y. Gao, H. Shiga, D.R. Wada, and M. Hisaoka. 2005. Population pharmacokinetics of olmesartan following oral administration of its prodrug, olmesartan medoxomil: in healthy volunteers and hypertensive patients. Clin Pharmacokinet. 44:1329-42. Abstract

15. P.A. Lockwood, P.A., J.A. Cook, W.E. Ewy, and J.W. Mandema. 2003. The use of clinical trial simulation to support dose selection: application to development of a new treatment for chronic neuropathic pain. Pharm Res. 20:1752-9. Abstract

16. U.G. Eriksson, J.W. Mandema, M.O. Karlsson, L. Frison, P.O. Gisleskog, U. Wahlby, B. Hamren, D. Gustafsson, and B.I. Eriksson. 2003. Pharmacokinetics of melagatran and the effect on ex vivo coagulation time in orthopaedic surgery patients receiving subcutaneous melagatran and oral ximelagatran: a population model analysis. Clin Pharmacokinet. 42:687-701. Abstract

17. B. Poland, and R. Wada. 2001. Combining drug-disease and economic modeling to inform drug development decisions. Drug Discov Today. 6:1165-1170. PDF

18. E. H. Cox, C. Veyrat-Follet C, S. L. Beal, E. Fuseau, S. Kenkare, and L. B. Sheiner. 1999. A population pharmacokinetic-pharmacodynamic analysis of repeated measures time-to-event pharmacodynamic responses: the antiemetic effect of ondansetron. J Pharmacokinet Biopharm. 27:625-44. Abstract

Selected Talks and Presentations

1. J. W. Mandema. 2010. Comparative Effectiveness in Drug Development. 6th International Symposium on Measurement and Kinetics of In Vivo Drug Effects, April 21-24, Leiden, The Netherlands. PDF

2. E. H. Cox, R. Wada, N. Zhang, and F. Wiegand. 2010. Meta-Analysis of Retention Rates of Post-Marketing Trials to Compare Effectiveness of Second Generation Antiepileptic Drugs. Population Approach Group in Europe (PAGE), June 8-11, Berlin, Germany. PDF

3. G. Nucci and J.W. Mandema. 2009. Model-Based Meta-Analysis of Concentration-D2 Occupancy in Healthy Volunteers and Schizophrenic Patients. American Conference on Pharmacometrics (ACOP), October 4-7, Mystic, CT. PDF

4. H. Li, J. Mandema, R. Wada, S. Jayawarden, P. Desjardins, G. Doyle, and D. Kellstein. 2009. Pharmacokinetics Nomograms For Onset And Offset Of Postoperative Dental Pain Relief With Ibuprofen. American Conference on Pharmacometrics (ACOP), October 4-7, Mystic, CT. PDF

5. J.W. Mandema, 2007. Model-based meta-analyses: value, complexity, and pitfalls. DIA/FDA Meeting, Jan 24-25, Washington DC

6. J.W. Mandema, 2006. Impact of Prior Knowledge on Drug Development Decisions: Case Studies Across Companies. Download PPT here

7. D. R. Wada, 2004. Drug and disease model in drug development: better knowledge, better decisions, better drugs. 8th World Congress on Clinical Pharmacology and Therapeutics, Aug 1-6, Brisbane, Australia PDF

8. D.R. Wada, 2002. Modeling from biomarkers to clinical outcome. 4th International Symposium on Measurement and Kinetics of In Vivo Drug Effects, April 22-27, Nordwijkerhout, The Netherlands