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Volumn 49, Issue 3, 2009, Pages 323-335

Trial treatment length optimization with an emphasis on disease progression studies

Author keywords

Clinical trial design; Disease progression studies; Optimal design; Pharmacometrics

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DISEASE COURSE; DRUG EFFECT; DRUG RESEARCH; MEDICAL LITERATURE; SIMULATION;

EID: 61449220937     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270008329560     Document Type: Article
Times cited : (8)

References (27)
  • 1
    • 34250675992 scopus 로고    scopus 로고
    • Using disease progression models as a tool to detect drug effect
    • Mould DR, Denman NG, Duffull S. Using disease progression models as a tool to detect drug effect. Clin Pharmacol Ther. 2007 ; 82: 81-86.
    • (2007) Clin Pharmacol Ther , vol.82 , pp. 81-86
    • Mould, D.R.1    Denman, N.G.2    Duffull, S.3
  • 2
    • 33750590174 scopus 로고    scopus 로고
    • Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect: An example in Alzheimer's disease
    • Lockwood P., Ewy W., Hermann D., Holford N. Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect: an example in Alzheimer's disease. Pharm Res. 2006 ; 23: 2050-2059.
    • (2006) Pharm Res , vol.23 , pp. 2050-2059
    • Lockwood, P.1    Ewy, W.2    Hermann, D.3    Holford, N.4
  • 3
    • 0034953568 scopus 로고    scopus 로고
    • Population pharmacokinetic analysis and optimization of the experimental design for mizolastine solution in children
    • Mentre F., Dubruc C., Thenot JP Population pharmacokinetic analysis and optimization of the experimental design for mizolastine solution in children. J Pharmacokinet Pharmacodyn. 2001 ; 28: 299-319.
    • (2001) J Pharmacokinet Pharmacodyn , vol.28 , pp. 299-319
    • Mentre, F.1    Dubruc, C.2    Thenot, J.P.3
  • 4
    • 33947277872 scopus 로고    scopus 로고
    • A D-optimal designed population pharmacokinetic study of oral itraconazole in adult cystic fibrosis patients
    • Hennig S., Waterhouse TH, Bell SC, et al. A D-optimal designed population pharmacokinetic study of oral itraconazole in adult cystic fibrosis patients. Br J Clin Pharmacol. 2007 ; 63: 438-450.
    • (2007) Br J Clin Pharmacol , vol.63 , pp. 438-450
    • Hennig, S.1    Waterhouse, T.H.2    Bell, S.C.3
  • 5
    • 0038336553 scopus 로고    scopus 로고
    • Prospective evaluation of a D-optimal designed population pharmacokinetic study
    • Green B., Duffull SB Prospective evaluation of a D-optimal designed population pharmacokinetic study. J Pharmacokin Pharmacodyn. 2003 ; 30: 145-161.
    • (2003) J Pharmacokin Pharmacodyn , vol.30 , pp. 145-161
    • Green, B.1    Duffull, S.B.2
  • 6
    • 34648822555 scopus 로고    scopus 로고
    • Optimal adaptive design in clinical drug development: A simulation example
    • Maloney A., Karlsson MO, Simonsson US Optimal adaptive design in clinical drug development: a simulation example. J Clin Pharmacol. 2007 ; 47: 1231-1243.
    • (2007) J Clin Pharmacol , vol.47 , pp. 1231-1243
    • Maloney, A.1    Karlsson, M.O.2    Simonsson, U.S.3
  • 8
    • 0035038023 scopus 로고    scopus 로고
    • Drug treatment effects on disease progression
    • Chan PL, Holford NH Drug treatment effects on disease progression. Annu Rev Pharmacol Toxicol. 2001 ; 41: 625-659.
    • (2001) Annu Rev Pharmacol Toxicol , vol.41 , pp. 625-659
    • Chan, P.L.1    Holford, N.H.2
  • 9
    • 34250649830 scopus 로고    scopus 로고
    • Developing models for disease progression
    • Ette EI, Williams PJ, eds. Hoboken, NJ: John Wiley;
    • Mould DR Developing models for disease progression. In: Ette EI, Williams PJ, eds. Pharmacometrics: The Science of Quantitative Pharmacology. Hoboken, NJ: John Wiley; 2007.
    • (2007) Pharmacometrics: The Science of Quantitative Pharmacology
    • Mould, D.R.1
  • 10
    • 0031003468 scopus 로고    scopus 로고
    • Learning versus confirming in clinical drug development
    • Sheiner LB Learning versus confirming in clinical drug development. Clin Pharmacol Ther. 1997 ; 61: 275-291.
    • (1997) Clin Pharmacol Ther , vol.61 , pp. 275-291
    • Sheiner, L.B.1
  • 12
    • 0031412765 scopus 로고    scopus 로고
    • Comparison of ED, EID, and API criteria for the robust optimization of sampling times in pharmacokinetics
    • Tod M., Rocchisani JM Comparison of ED, EID, and API criteria for the robust optimization of sampling times in pharmacokinetics. J Pharmacokinet Biopharm. 1997 ; 25: 515-537.
    • (1997) J Pharmacokinet Biopharm , vol.25 , pp. 515-537
    • Tod, M.1    Rocchisani, J.M.2
  • 13
    • 28444436619 scopus 로고    scopus 로고
    • Optimal design for model discrimination and parameter estimation for itraconazole population pharmacokinetics in cystic fibrosis patients
    • Waterhouse TH, Redmann S., Duffull SB, Eccleston JA Optimal design for model discrimination and parameter estimation for itraconazole population pharmacokinetics in cystic fibrosis patients. J Pharmacokinet Pharmacodyn. 2005 ; 32: 521-545.
    • (2005) J Pharmacokinet Pharmacodyn , vol.32 , pp. 521-545
    • Waterhouse, T.H.1    Redmann, S.2    Duffull, S.B.3    Eccleston, J.A.4
  • 14
    • 28444445596 scopus 로고    scopus 로고
    • Some considerations on the design of population pharmacokinetic studies
    • Duffull S., Waterhouse T., Eccleston J. Some considerations on the design of population pharmacokinetic studies. J Pharmacokinet Pharmacodyn. 2005 ; 32: 441-457.
    • (2005) J Pharmacokinet Pharmacodyn , vol.32 , pp. 441-457
    • Duffull, S.1    Waterhouse, T.2    Eccleston, J.3
  • 16
    • 0028141439 scopus 로고
    • The effect of tacrine and lecithin in Alzheimer's disease: A population pharmacodynamic analysis of five clinical trials
    • Holford NH, Peace K. The effect of tacrine and lecithin in Alzheimer's disease: a population pharmacodynamic analysis of five clinical trials. Eur J Clin Pharmacol. 1994 ; 47: 17-23.
    • (1994) Eur J Clin Pharmacol , vol.47 , pp. 17-23
    • Holford, N.H.1    Peace, K.2
  • 17
    • 33947105151 scopus 로고    scopus 로고
    • Levodopa slows progression of Parkinson's disease: External validation by clinical trial simulation
    • Chan PL, Nutt JG, Holford NH Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation. Pharm Res. 2007 ; 24: 791-802.
    • (2007) Pharm Res , vol.24 , pp. 791-802
    • Chan, P.L.1    Nutt, J.G.2    Holford, N.H.3
  • 18
    • 0026452038 scopus 로고
    • Methodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine
    • Holford NH, Peace KE Methodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine. Proc Natl Acad Sci USA. 1992 ; 89: 11466-11470.
    • (1992) Proc Natl Acad Sci USA , vol.89 , pp. 11466-11470
    • Holford, N.H.1    Peace, K.E.2
  • 20
    • 33745786419 scopus 로고    scopus 로고
    • Disease progression and pharmacodynamics in Parkinson disease: Evidence for functional protection with levodopa and other treatments
    • Holford NH, Chan PL, Nutt JG, Kieburtz K., Shoulson I. Disease progression and pharmacodynamics in Parkinson disease: evidence for functional protection with levodopa and other treatments. J Pharmacokinet Pharmacodyn. 2006 ; 33: 281-311.
    • (2006) J Pharmacokinet Pharmacodyn , vol.33 , pp. 281-311
    • Holford, N.H.1    Chan, P.L.2    Nutt, J.G.3    Kieburtz, K.4    Shoulson, I.5
  • 22
    • 23944435458 scopus 로고    scopus 로고
    • PsN-Toolkit: A collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM
    • Lindbom L., Pihlgren P., Jonsson EN PsN-Toolkit: a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005 ; 79: 241-257.
    • (2005) Comput Methods Programs Biomed , vol.79 , pp. 241-257
    • Lindbom, L.1    Pihlgren, P.2    Jonsson, E.N.3
  • 24
    • 0037201007 scopus 로고    scopus 로고
    • Fisher information matrix for non-linear mixed-effects models: Evaluation and application for optimal design of enoxaparin population pharmacokinetics
    • Retout S., Mentre F., Bruno R. Fisher information matrix for non-linear mixed-effects models: evaluation and application for optimal design of enoxaparin population pharmacokinetics. Stat Med. 2002 ; 21: 2623-2639.
    • (2002) Stat Med , vol.21 , pp. 2623-2639
    • Retout, S.1    Mentre, F.2    Bruno, R.3
  • 25
    • 0035049209 scopus 로고    scopus 로고
    • Optimal design of a population pharmacodynamic experiment for ivabradine
    • Duffull SB, Mentre F., Aarons L. Optimal design of a population pharmacodynamic experiment for ivabradine. Pharm Res. 2001 ; 18: 83-89.
    • (2001) Pharm Res , vol.18 , pp. 83-89
    • Duffull, S.B.1    Mentre, F.2    Aarons, L.3
  • 26
    • 68149181961 scopus 로고    scopus 로고
    • Optimal design to estimate the time varying receptor occupancy relationship in a PET experiment
    • Zamuner S., Gomeni R. Optimal design to estimate the time varying receptor occupancy relationship in a PET experiment. Presented at: Annual Meeting of the Population Approach Group in Europe ; June 14-16, 2007 ; Copenhagen, Denmark. www.page-meeting.org/?abstract=1099.
    • Presented At: Annual Meeting of the Population Approach Group in Europe
    • Zamuner, S.1    Gomeni, R.2
  • 27
    • 0019785890 scopus 로고
    • Understanding the dose-effect relationship: Clinical application of pharmacokinetic-pharmacodynamic models
    • Holford NHG, Sheiner LB Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin Pharmacokinet. 1981 ; 6: 429-453.
    • (1981) Clin Pharmacokinet , vol.6 , pp. 429-453
    • Holford, N.H.G.1    Sheiner, L.B.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.