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Volumn , Issue , 2008, Pages 1-26

Simulation in Clinical Drug Development

Author keywords

Biosimulation; Drug development; Phase I studies; Phase II studies; Phase III

Indexed keywords


EID: 84889297594     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527622672.ch1     Document Type: Chapter
Times cited : (4)

References (49)
  • 1
    • 84889341470 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration: Innovation/stagnation. Challenge and opportunity on the critical path to new medical products. View from the U.S. Food and Drug Administration (FDA). U.S. Department of Health and Human Services, Food and Drug Administration, Washington, D.C., 2004
    • U.S. Food and Drug Administration: Innovation/stagnation. Challenge and opportunity on the critical path to new medical products. View from the U.S. Food and Drug Administration (FDA). U.S. Department of Health and Human Services, Food and Drug Administration, Washington, D.C., 2004.
  • 2
    • 84889485844 scopus 로고    scopus 로고
    • EFPIA: Innovative medicine for Europe. EFPIA, Brussels, 2004
    • EFPIA: Innovative medicine for Europe. EFPIA, Brussels, 2004.
  • 3
    • 33845563945 scopus 로고    scopus 로고
    • Tufts Center for the Study of Drug Development: Backgrounder: how new drugs move through the development and approval process
    • Tufts Center, Boston
    • Tufts Center for the Study of Drug Development: Backgrounder: how new drugs move through the development and approval process. Tufts Center, Boston, 2001
    • (2001)
  • 7
    • 0033810574 scopus 로고    scopus 로고
    • Pharmacometrics: modelling and simulation tools to improve decision making in clinical drug development
    • Gieschke, R., Steimer, J. L.: Pharmacometrics: modelling and simulation tools to improve decision making in clinical drug development. Eur J Drug Metab Pharmacokinet 2000, 25:49-58.
    • (2000) Eur J Drug Metab Pharmacokinet , vol.25 , pp. 49-58
    • Gieschke, R.1    Steimer, J.L.2
  • 8
    • 33847028671 scopus 로고    scopus 로고
    • Mechanism-based pharmacokineticpharmacodynamic modeling: biophase distribution, receptor theory, and dynamical systems analysis
    • Danhof, M., de Jongh, J., De Lange, E. C., Della Pasqua, O., Ploeger, B. A., Voskuyl, R. A.: Mechanism-based pharmacokineticpharmacodynamic modeling: biophase distribution, receptor theory, and dynamical systems analysis. Annu Rev Pharmacol Toxicol 2007, 47:357-400.
    • (2007) Annu Rev Pharmacol Toxicol , vol.47 , pp. 357-400
    • Danhof, M.1    De Jongh, J.2    De Lange, E.C.3    Della Pasqua, O.4    Ploeger, B.A.5    Voskuyl, R.A.6
  • 9
    • 0034119297 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic modeling in drug development
    • Sheiner, L. B., Steimer, J. L.: Pharmacokinetic/pharmacodynamic modeling in drug development. Annu Rev Pharmacol Toxicol 2000, 40:67-95.
    • (2000) Annu Rev Pharmacol Toxicol , vol.40 , pp. 67-95
    • Sheiner, L.B.1    Steimer, J.L.2
  • 10
    • 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
  • 12
    • 0031003468 scopus 로고    scopus 로고
    • Learning versus confirming in clinical drug development
    • Sheiner, L. B.: 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
  • 13
    • 84889375226 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic variability: estimation and appraisal of its impact on dose optimization with an example of gender differences. Dose optimization in drug development.
    • Krishna, R., ed., Marcel Dekker, New York
    • Piotrovsky, V.: Pharmacokinetic and pharmacodynamic variability: estimation and appraisal of its impact on dose optimization with an example of gender differences. In: Krishna, R., ed. Dose optimization in drug development. (Drugs and the pharmaceutical sciences, volume 161) Marcel Dekker, New York, 2006.
    • (2006) Drugs and the pharmaceutical sciences , vol.161
    • Piotrovsky, V.1
  • 14
    • 0037407951 scopus 로고    scopus 로고
    • Galantamine population pharmacokinetics in patients with Alzheimer's disease: modeling and simulations
    • Piotrovsky, V., Van Peer, A., Van Osselaer, N., Armstrong, M., Aerssens, J.: Galantamine population pharmacokinetics in patients with Alzheimer's disease: modeling and simulations. J Clin Pharmacol 2003, 43:514-523.
    • (2003) J Clin Pharmacol , vol.43 , pp. 514-523
    • Piotrovsky, V.1    Van Peer, A.2    Van Osselaer, N.3    Armstrong, M.4    Aerssens, J.5
  • 16
    • 0035693563 scopus 로고    scopus 로고
    • Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making
    • Gobburu, J. V., Marroum, P. J.: Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making. Clin Pharmacokinet 2001, 40:883-892.
    • (2001) Clin Pharmacokinet , vol.40 , pp. 883-892
    • Gobburu, J.V.1    Marroum, P.J.2
  • 17
    • 12344274031 scopus 로고    scopus 로고
    • Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective
    • Marcel Dekker, New York
    • Kimko, H. C., Duffull, S. B.: Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York, 2003.
    • (2003) Drugs and the pharmaceutical sciences , vol.127
    • Kimko, H.C.1    Duffull, S.B.2
  • 20
    • 0034764915 scopus 로고    scopus 로고
    • Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check
    • Yano, Y., Beal, S. L., Sheiner, L. B.: Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J Pharmacokinet Pharmacodyn 2001, 28:171-192.
    • (2001) J Pharmacokinet Pharmacodyn , vol.28 , pp. 171-192
    • Yano, Y.1    Beal, S.L.2    Sheiner, L.B.3
  • 21
    • 33947224293 scopus 로고    scopus 로고
    • Determination of model appropriateness
    • Kimko, H. C., Duffull, S. B., eds., Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, Marcel Dekker, New York
    • Williams, P. J., Ette, E. I.: Determination of model appropriateness. In: Kimko, H. C., Duffull, S. B., eds. Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York, 2003.
    • (2003) , vol.127
    • Williams, P.J.1    Ette, E.I.2
  • 22
    • 33745804100 scopus 로고    scopus 로고
    • Prediction discrepancies for the evaluation of nonlinear mixed-effects models
    • Mentre, F., Escolano, S.: Prediction discrepancies for the evaluation of nonlinear mixed-effects models. J Pharmacokinet Pharmacodyn 2006, 33:345-367.
    • (2006) J Pharmacokinet Pharmacodyn , vol.33 , pp. 345-367
    • Mentre, F.1    Escolano, S.2
  • 23
    • 84889316901 scopus 로고    scopus 로고
    • Sensitivity analysis of pharmacokinetic and pharmacodynamic models in clinical trial simulation and design
    • Kimko, H. C., Duffull, S. B., eds., Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, Marcel Dekker, New York
    • Nestorov, I. A.: Sensitivity analysis of pharmacokinetic and pharmacodynamic models in clinical trial simulation and design. In: Kimko, H. C., Duffull, S. B., eds. Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York, 2003.
    • (2003) , vol.127
    • Nestorov, I.A.1
  • 24
    • 18844394287 scopus 로고    scopus 로고
    • Effect of uncertainty about population parameters on pharmacodynamics-based prediction of clinical trial power
    • Kraiczi, H., Frisen, M.: Effect of uncertainty about population parameters on pharmacodynamics-based prediction of clinical trial power. Contemp Clin Trials 2005, 26:118-130.
    • (2005) Contemp Clin Trials , vol.26 , pp. 118-130
    • Kraiczi, H.1    Frisen, M.2
  • 26
    • 85057447281 scopus 로고    scopus 로고
    • Drug efficacy analysis as an exercise in dynamic (indirectresponse) population PK-PD modelling
    • Population Approach Group in Europe (PAGE) Meeting, Paris, Available at
    • Piotrovsky, V.: Drug efficacy analysis as an exercise in dynamic (indirectresponse) population PK-PD modelling. Population Approach Group in Europe (PAGE) Meeting, Paris, 2002. Available at: http://www.pagemeeting. org/default.asp?abstract=305.
    • (2002)
    • Piotrovsky, V.1
  • 27
    • 23744516690 scopus 로고    scopus 로고
    • Disease system analysis: basic disease progression models in degenerative disease
    • Post, T.M., Freijer, J. I., DeJongh, J., Danhof, M.: Disease system analysis: basic disease progression models in degenerative disease. Pharm Res 2005, 22:1038-1049.
    • (2005) Pharm Res , vol.22 , pp. 1038-1049
    • Post, T.M.1    Freijer, J.I.2    DeJongh, J.3    Danhof, M.4
  • 28
    • 84889275370 scopus 로고    scopus 로고
    • Input-output models
    • Kimko, H. C., Duffull, S. B., eds., Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, Marcel Dekker, New York
    • Holford, N. H. G.: Input-output models. In: Kimko, H. C., Duffull, S. B., eds. Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York, 2003.
    • (2003) , vol.127
    • Holford, N.H.G.1
  • 29
    • 33544459717 scopus 로고    scopus 로고
    • Defining covariate distribution models for clinical trial simulation
    • Kimko, H. C., Duffull, S. B., eds., Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York
    • Mould, D. R.: Defining covariate distribution models for clinical trial simulation. In: Kimko, H. C., Duffull, S. B., eds. Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York, 2003.
    • (2003)
    • Mould, D.R.1
  • 30
    • 33751411139 scopus 로고    scopus 로고
    • Simulation of correlated continuous and categorical variables using a single multivariate distribution
    • Epub ahead of print
    • Tannenbaum, S. J., Holford, N. H., Lee, H., Peck, C. C., Mould, D. R.: Simulation of correlated continuous and categorical variables using a single multivariate distribution. J Pharmacokinet Pharmacodyn 2006 [Epub ahead of print].
    • (2006) J Pharmacokinet Pharmacodyn
    • Tannenbaum, S.J.1    Holford, N.H.2    Lee, H.3    Peck, C.C.4    Mould, D.R.5
  • 31
    • 33751411139 scopus 로고    scopus 로고
    • Simulation of correlated continuous and categorical variables using a single multivariate distribution
    • Tannenbaum, S. J., Holford, N. H., Lee, H., Peck, C. C., Mould, D. R.: Simulation of correlated continuous and categorical variables using a single multivariate distribution. J Pharmacokinet Pharmacodyn 2006, 33:773-794.
    • (2006) J Pharmacokinet Pharmacodyn , vol.33 , pp. 773-794
    • Tannenbaum, S.J.1    Holford, N.H.2    Lee, H.3    Peck, C.C.4    Mould, D.R.5
  • 32
    • 4644278487 scopus 로고    scopus 로고
    • Pharmionics: research on what patients do with prescription drugs
    • Urquhart, J.: Pharmionics: research on what patients do with prescription drugs. Pharmacoepidemiol Drug Saf 2004, 13:587-590.
    • (2004) Pharmacoepidemiol Drug Saf , vol.13 , pp. 587-590
    • Urquhart, J.1
  • 33
    • 84889469836 scopus 로고    scopus 로고
    • Protocol deviations and execution models
    • Kimko, H. C., Duffull, S. B., eds., Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, Marcel Dekker, New York
    • Kastrissios, H., Girard, P.: Protocol deviations and execution models. In: Kimko, H. C., Duffull, S. B., eds. Simulation for designing clinical trials. A pharmacokinetic-pharmacodynamic modeling perspective. (Drugs and the pharmaceutical sciences, volume 127) Marcel Dekker, New York, 2003.
    • (2003) , vol.127
    • Kastrissios, H.1    Girard, P.2
  • 34
    • 9244240736 scopus 로고    scopus 로고
    • Estimating treatment effect in the presence of noncompliance measured with error: precision and robustness of data analysis methods
    • Kenna, L. A., Sheiner, L. B.: Estimating treatment effect in the presence of noncompliance measured with error: precision and robustness of data analysis methods. Statist Med 2004, 23:3561-3580.
    • (2004) Statist Med , vol.23 , pp. 3561-3580
    • Kenna, L.A.1    Sheiner, L.B.2
  • 35
    • 15244355850 scopus 로고    scopus 로고
    • Clinical trial simulation: a tool for understanding study failures and preventing them
    • Girard, P.: Clinical trial simulation: a tool for understanding study failures and preventing them. Basic Clin Pharmacol Toxicol 2005, 96:228-234.
    • (2005) Basic Clin Pharmacol Toxicol , vol.96 , pp. 228-234
    • Girard, P.1
  • 36
    • 84889293990 scopus 로고    scopus 로고
    • Population pharmacokinetics meta-analysis of recombinant human erythropoietin in healthy subjects
    • in press
    • Olsson Gislekog, P., Jacqmin, P., Perez-Ruixo, J. J.: Population pharmacokinetics meta-analysis of recombinant human erythropoietin in healthy subjects. Clin Pharmacokin 2006 (in press).
    • (2006) Clin Pharmacokin
    • Olsson Gislekog, P.1    Jacqmin, P.2    Perez-Ruixo, J.J.3
  • 37
    • 24644441758 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after multiple subcutaneous doses in healthy subjects
    • Krzyzanski, W., Jusko, W. J., Wacholtz, M. C., Minton, N., Cheung, W. K.: Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after multiple subcutaneous doses in healthy subjects. Eur J Pharm Sci 2005, 26:295-306.
    • (2005) Eur J Pharm Sci , vol.26 , pp. 295-306
    • Krzyzanski, W.1    Jusko, W.J.2    Wacholtz, M.C.3    Minton, N.4    Cheung, W.K.5
  • 38
    • 15244357228 scopus 로고    scopus 로고
    • Mixedeffects modelling of the interspecies pharmacokinetic scaling of pegylated human erythropoietin
    • Jolling, K., Perez-Ruixo, J. J., Hemeryck, A., Vermeulen, A., Greway, T.: Mixedeffects modelling of the interspecies pharmacokinetic scaling of pegylated human erythropoietin. Eur J Pharm Sci 2005, 24:465-475.
    • (2005) Eur J Pharm Sci , vol.24 , pp. 465-475
    • Jolling, K.1    Perez-Ruixo, J.J.2    Hemeryck, A.3    Vermeulen, A.4    Greway, T.5
  • 39
    • 34548077901 scopus 로고    scopus 로고
    • Interspecies comparison of pharmacokinetics and pharmacodynamics of recombinant human erythropoietin (rH-EPO)
    • in press
    • Woo, S., Jusko, W. J.: Interspecies comparison of pharmacokinetics and pharmacodynamics of recombinant human erythropoietin (rH-EPO). Drug Metabolism and Disposition 2007 (in press).
    • (2007) Drug Metabolism and Disposition
    • Woo, S.1    Jusko, W.J.2
  • 40
    • 0033826402 scopus 로고    scopus 로고
    • Signaling induced by erythropoietin and stem cell factor in UT-7/Epo cells: transient versus sustained proliferation
    • Erickson-Miller, C. L., Pelus, L. M., Lord, K. A.: Signaling induced by erythropoietin and stem cell factor in UT-7/Epo cells: transient versus sustained proliferation. Stem Cells 2000, 18:366-373.
    • (2000) Stem Cells , vol.18 , pp. 366-373
    • Erickson-Miller, C.L.1    Pelus, L.M.2    Lord, K.A.3
  • 41
    • 30544440040 scopus 로고    scopus 로고
    • Monte Carlo simulation in the evaluation of susceptibility breakpoints: predicting the future: insights from the society of infectious diseases pharmacists
    • Ambrose, P. G. Monte Carlo simulation in the evaluation of susceptibility breakpoints: predicting the future: insights from the society of infectious diseases pharmacists. Pharmacotherapy 2006, 26:129-134.
    • (2006) Pharmacotherapy , vol.26 , pp. 129-134
    • Ambrose, P.G.1
  • 42
    • 0035173688 scopus 로고    scopus 로고
    • Use of preclinical data for selection of a phase II/III dose for evernimicin and identification of a preclinical MIC breakpoint
    • Drusano, G. L., Preston, S. L., Hardalo, C., Hare, R., Banfield, C., Andes, D., Vesga, O., Craig, W. A.: Use of preclinical data for selection of a phase II/III dose for evernimicin and identification of a preclinical MIC breakpoint. Antimicrob Agents Chemother 2001, 45:13-22.
    • (2001) Antimicrob Agents Chemother , vol.45 , pp. 13-22
    • Drusano, G.L.1    Preston, S.L.2    Hardalo, C.3    Hare, R.4    Banfield, C.5    Andes, D.6    Vesga, O.7    Craig, W.A.8
  • 43
    • 0031952586 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men
    • Craig, W. A.: Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 1998, 26:1-10.
    • (1998) Clin Infect Dis , vol.26 , pp. 1-10
    • Craig, W.A.1
  • 45
    • 0037534027 scopus 로고    scopus 로고
    • Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval
    • Peck, C. C., Rubin, D. B., Sheiner, L. B.: Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin Pharmacol Ther 2003, 73:481-490.
    • (2003) Clin Pharmacol Ther , vol.73 , pp. 481-490
    • Peck, C.C.1    Rubin, D.B.2    Sheiner, L.B.3
  • 46
    • 0344515273 scopus 로고    scopus 로고
    • The use of clinical trial simulation to support dose selection: application to development of a new treatment for chronic neuropathic pain
    • Lockwood, P. A., Cook, J. A., Ewy, W. E., Mandema, J. W.: The use of clinical trial simulation to support dose selection: application to development of a new treatment for chronic neuropathic pain. Pharm Res 2003, 20:1752-1759.
    • (2003) Pharm Res , vol.20 , pp. 1752-1759
    • Lockwood, P.A.1    Cook, J.A.2    Ewy, W.E.3    Mandema, J.W.4
  • 48
    • 15844380596 scopus 로고    scopus 로고
    • Modelling and simulation to improve decision-making in clinical development
    • Burman, C. F., Hamren, B., Olsson, P.: Modelling and simulation to improve decision-making in clinical development. Pharmaceut Statist 2005, 4:47-58.
    • (2005) Pharmaceut Statist , vol.4 , pp. 47-58
    • Burman, C.F.1    Hamren, B.2    Olsson, P.3
  • 49
    • 15244341760 scopus 로고    scopus 로고
    • Predicting the outcome of phase III trials using phase II data: a case study of clinical trial simulation in late stage drug development
    • De Ridder, F.: Predicting the outcome of phase III trials using phase II data: a case study of clinical trial simulation in late stage drug development. Basic Clin Pharmacol Toxicol 2005, 96:235-241.
    • (2005) Basic Clin Pharmacol Toxicol , vol.96 , pp. 235-241
    • De Ridder, F.1


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