Publications

Selected Publications on Modeling and Simulation

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

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

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

3. 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

4. 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