Use of modeling and simulation to optimize dose-finding strategies

Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective

Volumn , Issue , 2002, Pages 289-312

  Mandema, Jaap W ^a   Wang, Wenping ^a  

^a PHARSIGHT CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84968881731     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (12)

1. MB Schoenhoff, JW Mandema. Clinical trial simulation: retrospective analysis of dose ranging trials in detrusor instability with tolterodine. Clin Pharmacol Ther 65: 203, 1999.
2. PA Lockwood, EH Cox, JW Mandema, J Koup, W Ewy, RJ Powell. Computer assisted trial design (CATD) to support dose selection for Cl-1008 in chronic neuropathic pain trials. Pharm Res 16:188, 1999.
3. LB Sheiner, JL Steimer. Pharmacokinetic/pharmacodynamic modeling in drug development. Annu Rev Pharmacol Toxicol 40:67-95, 2000.
4. NHG Holford, HKimko C, JPR Monteleone, CC Peck. Simulation of clinical trials. Annu Rev Pharmacol Toxicol 40:209-234, 2000.
5. J Teall, M Tuchman, N Cutler, M Gross, E Willoughby, B Smith, K Jiang, S Reines, G Block. Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence. A placebo-controlled, outpatient study. Rizatriptan 022 Study Group. Headache 38:281-287, 1998.
6. WH Visser, GM Terwindt, SA Reines, K Jiang, CR Lines, MD Ferrari. Rizatriptan vs sumatriptan in the acute treatment of migraine. A placebo controlled, dose-ranging study. Dutch/US Rizatriptan study group. Arch Neurol 53:1132-1137, 1996.
7. NT Mathew, M Asgharnejad, M Peykamian, A Laurenza. Naratriptan is effective and well tolerated in the acute treatment of migraine. Results of a double-blind, placebo-controlled, crossover study. The Naratriptan S2WA3003 Study Group. Neurology 49:1485-1490, 1997.
8. V Pfaffenrath, G Cunin, G Sjonell, S Prendergast. Efficacy and safety of sumatriptan tablets (25 mg, 50 mg, and 100 mg) in the acute treatment of migraine: defining the optimum doses of oral sumatriptan. Headache 38:184-190, 1998.
9. C Dahlof, C Edwards, S Ludlow, PDOB Winter, M Tansey, and the oral sumatriptan dose-defining study group. Sumatriptan- an oral dose-defining study. Eur Neurol 31: 300-305, 1991.
10. AM Rapoport, NM Ramadan, JU Adelman, NT Mathew, AH Elkind, DB Kudrow, NL Earl. Optimizing the dose of zolmitriptan (Zomig, 311C90) for the acute treatment of migraine. A multicenter, double-blind, placebo-controlled, dose range-finding study. The 017 Clinical Trial Study Group. Neurology 49:1210-1218, 1997.
11. NDA 20-768, Zolmitriptan efficacy review, Study 008, CDER, FDA, 1997, pp 4953.
12. SL Beal, AJ Boeckman, LB Sheiner. NONMEM users guide. NONMEM project group. University of California, San Francisco, 1996.