-
1
-
-
84889341470
-
-
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
-
-
EFPIA: Innovative medicine for Europe. EFPIA, Brussels, 2004
-
EFPIA: Innovative medicine for Europe. EFPIA, Brussels, 2004.
-
-
-
-
3
-
-
33845563945
-
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)
-
-
-
4
-
-
4444342056
-
Rebuilding big pharma's business model
-
Gilbert, J., P. Henske, and A. Singh: Rebuilding big pharma's business model. InVivo (The Business & Medicine Report), Windhover Information, 21, No. 10, 2003.
-
(2003)
InVivo (The Business & Medicine Report), Windhover Information
, vol.21
, Issue.10
-
-
Gilbert, J.1
Henske, P.2
Singh, A.3
-
5
-
-
33745779940
-
Model-based drug development: the road to quantitative pharmacology
-
Zhang, L., Sinha, V., Forgue, S. T., Callies, S., Ni, L., Peck, R., Allerheiligen, S. R.: Model-based drug development: the road to quantitative pharmacology. J Pharmacokinet Pharmacodyn 2006, 33:369-393.
-
(2006)
J Pharmacokinet Pharmacodyn
, vol.33
, pp. 369-393
-
-
Zhang, L.1
Sinha, V.2
Forgue, S.T.3
Callies, S.4
Ni, L.5
Peck, R.6
Allerheiligen, S.R.7
-
6
-
-
28244501254
-
How modeling and simulation have enhanced decision making in new drug development
-
Miller, R., Ewy, W., Corrigan, B. W., Ouellet, D., Hermann, D., Kowalski, K. G., Lockwood, P., Koup J. R, Donevan, S., El-Kattan, A., Li, C. S., Werth, J. L., Feltner, D. E., Lalonde, R. L.: How modeling and simulation have enhanced decision making in new drug development. J Pharmacokinet Pharmacodyn 2005, 32:185-197.
-
(2005)
J Pharmacokinet Pharmacodyn
, vol.32
, pp. 185-197
-
-
Miller, R.1
Ewy, W.2
Corrigan, B.W.3
Ouellet, D.4
Hermann, D.5
Kowalski, K.G.6
Lockwood, P.7
Koup, J.R.8
Donevan, S.9
El-Kattan, A.10
Li, C.S.11
Werth, J.L.12
Feltner, D.E.13
Lalonde, R.L.14
-
7
-
-
0033810574
-
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
-
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
-
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
-
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
-
11
-
-
0034074181
-
Simulation of clinical trials
-
Holford, N.H. G., Kimko, H. C., Monteleone, J. P. R., Peck, CC.: Simulation of clinical trials. Annu Rev Pharmacol Toxicol 2000, 40:209-234.
-
(2000)
Annu Rev Pharmacol Toxicol
, vol.40
, pp. 209-234
-
-
Holford, N.H.G.1
Kimko, H.C.2
Monteleone, J.P.R.3
Peck, C.C.4
-
12
-
-
0031003468
-
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
-
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
-
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
-
15
-
-
0032769235
-
Population pharmacokinetics. A regulatory perspective
-
Sun, H., Fadiran, E. O., Jones, C. D., Lesko, L., Huang, S. M., Higgins, K., Hu, C., Machado, S., Maldonado, S., Williams, R., Hossain, M., Ette, E. I.: Population pharmacokinetics. A regulatory perspective. Clin Pharmacokinet 1999, 37:41-58.
-
(1999)
Clin Pharmacokinet
, vol.37
, pp. 41-58
-
-
Sun, H.1
Fadiran, E.O.2
Jones, C.D.3
Lesko, L.4
Huang, S.M.5
Higgins, K.6
Hu, C.7
Machado, S.8
Maldonado, S.9
Williams, R.10
Hossain, M.11
Ette, E.I.12
-
16
-
-
0035693563
-
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
-
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
-
18
-
-
34250749661
-
Modelbased Drug Development
-
Lalonde, R. L., Kowalski, K. G., Hutmacher, M. M., Ewy, W., Nichols, D. J., Milligan, P. A., Corrigan, B. W., Lockwood, P. A., Marshall, S. A., Benincosa, L. J., Tensfeldt, T. G., Parivar, K., Amantea, M., Glue, P., Koide, H., Miller, R.: Modelbased Drug Development. Clin Pharmacol Ther 2007, 82:21-32.
-
(2007)
Clin Pharmacol Ther
, vol.82
, pp. 21-32
-
-
Lalonde, R.L.1
Kowalski, K.G.2
Hutmacher, M.M.3
Ewy, W.4
Nichols, D.J.5
Milligan, P.A.6
Corrigan, B.W.7
Lockwood, P.A.8
Marshall, S.A.9
Benincosa, L.J.10
Tensfeldt, T.G.11
Parivar, K.12
Amantea, M.13
Glue, P.14
Koide, H.15
Miller, R.16
-
19
-
-
34447564991
-
Pharmacometrics and the transition to model-based development
-
Grasela, T. H., Dement, C. W., Kolterman, O. G., Fineman, M. S., Grasela, D. M., Honig, P., Antal, E. J., Bjornsson, T. D., Loh, E.: Pharmacometrics and the transition to model-based development. Clin Pharmacol Ther 2007, 82:137-142.
-
(2007)
Clin Pharmacol Ther
, vol.82
, pp. 137-142
-
-
Grasela, T.H.1
Dement, C.W.2
Kolterman, O.G.3
Fineman, M.S.4
Grasela, D.M.5
Honig, P.6
Antal, E.J.7
Bjornsson, T.D.8
Loh, E.9
-
20
-
-
0034764915
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
44
-
-
0032515386
-
Pharmacodynamics of levofloxacin: a new paradigm for early clinical trials
-
Preston, S. L., Drusano, G. L., Berman, A. L., Fowler, C. L., Chow, A. T., Dornseif, B., Reichl, V., Natarajan, J., Corrado, M:. Pharmacodynamics of levofloxacin: a new paradigm for early clinical trials. JAMA 1998, 279:125-129.
-
(1998)
JAMA
, vol.279
, pp. 125-129
-
-
Preston, S.L.1
Drusano, G.L.2
Berman, A.L.3
Fowler, C.L.4
Chow, A.T.5
Dornseif, B.6
Reichl, V.7
Natarajan, J.8
Corrado, M.9
-
45
-
-
0037534027
-
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
-
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
-
47
-
-
33644812717
-
Model-based development of gemcabene, a new lipid-altering agent
-
Mandema, J. W., Hermann, D., Wang, W., Sheiner, T., Milad, M., Bakker-Arkema, R., Hartman, D.: Model-based development of gemcabene, a new lipid-altering agent. AAPS J 2005, 7:E513-E522.
-
(2005)
AAPS J
, vol.7
-
-
Mandema, J.W.1
Hermann, D.2
Wang, W.3
Sheiner, T.4
Milad, M.5
Bakker-Arkema, R.6
Hartman, D.7
-
48
-
-
15844380596
-
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
-
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
|