-
2
-
-
0032054154
-
The cost-benefit of a randomized trial to a health care organization
-
Hornberger J,Eghtesady P.The cost-benefit of a randomized trial to a health care organization.Controlled Clinical Trials. 1998;19:198-211.
-
(1998)
Controlled Clinical Trials
, vol.19
, pp. 198-211
-
-
Hornberger, J.1
Eghtesady, P.2
-
3
-
-
67651027168
-
Optimal cost-effective designs of phase II proof of concept trials and associated go-no-go decisions
-
Chen C,Beckman RA.Optimal cost-effective designs of phase II proof of concept trials and associated go-no-go decisions.J Biopharm Stat. 2009;19:424-436.
-
(2009)
J Biopharm Stat
, vol.19
, pp. 424-436
-
-
Chen, C.1
Beckman, R.A.2
-
5
-
-
33845898530
-
Sample size and the probability of a successful trial
-
Chuang-Stein C.Sample size and the probability of a successful trial.Pharm Stat. 2006;5 (4): 305-309.
-
(2006)
Pharm Stat
, vol.5
, Issue.4
, pp. 305-309
-
-
Chuang-Stein, C.1
-
6
-
-
79955728049
-
A revisit of sample size decision in confirmatory trials
-
Chuang-Stein C,Yang R.A revisit of sample size decision in confirmatory trials.Stat Biopharm Res. 2010;2:239-248.
-
(2010)
Stat Biopharm Res
, vol.2
, pp. 239-248
-
-
Chuang-Stein, C.1
Yang, R.2
-
7
-
-
79955708726
-
A quantitative approach for making go/no go decisions in drug development
-
Chuang-Stein C,Kirby S,French J, et al.A quantitative approach for making go/no go decisions in drug development.Drug Inf J. 2011;45:187-202.
-
(2011)
Drug Inf J
, vol.45
, pp. 187-202
-
-
Chuang-Stein, C.1
Kirby, S.2
French, J.3
-
8
-
-
15844411320
-
Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan
-
Julious SA,Swank DJ.Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan.Pharm Stat. 2005;4:37-46.
-
(2005)
Pharm Stat
, vol.4
, pp. 37-46
-
-
Julious, S.A.1
Swank, D.J.2
-
10
-
-
84873866042
-
Impact of dose selection strategies on the success of drug development programs
-
Antonijevic Z.Impact of dose selection strategies on the success of drug development programs.Drug Inf J. 2009;4:104-106.
-
(2009)
Drug Inf J
, vol.4
, pp. 104-106
-
-
Antonijevic, Z.1
-
11
-
-
84866736056
-
Impact of dose selection strategies used in phase II on the probability of success in phase III
-
Antonijevic Z,Pinheiro J,Fardipour P,Roger JL.Impact of dose selection strategies used in phase II on the probability of success in phase III.Stat Biopharm Res. 2010;2 (4): 469-486.
-
(2010)
Stat Biopharm Res
, vol.2
, Issue.4
, pp. 469-486
-
-
Antonijevic, Z.1
Pinheiro, J.2
Fardipour, P.3
Roger, J.L.4
-
12
-
-
84861527242
-
Adaptive and model-based dose-ranging trials: quantitative evaluation and recommendations (with discussions and rejoinder)
-
Pinheiro J,Sax F,Antonijevic Z, et al.Adaptive and model-based dose-ranging trials: quantitative evaluation and recommendations (with discussions and rejoinder).Stat Biopharm Res. 2010;2 (4): 435-454.
-
(2010)
Stat Biopharm Res
, vol.2
, Issue.4
, pp. 435-454
-
-
Pinheiro, J.1
Sax, F.2
Antonijevic, Z.3
-
13
-
-
78249240704
-
Model-based drug development-a new paradigm for efficient drug development
-
Kowalski KG,Ewy W,Hutmacher MM,Miller R,Krishnaswami S.Model-based drug development-a new paradigm for efficient drug development.Biopharm Rep. 2007;15 (2): 2-22.
-
(2007)
Biopharm Rep
, vol.15
, Issue.2
, pp. 2-22
-
-
Kowalski, K.G.1
Ewy, W.2
Hutmacher, M.M.3
Miller, R.4
Krishnaswami, S.5
-
14
-
-
43949143899
-
Modeling and simulation to support dose selection and clinical development of SC-75416, a selective COX-2 inhibitor for the treatment of acute and chronic pain
-
Kowalski KG,Olson S,Remmers AE,Hutmacher MM.Modeling and simulation to support dose selection and clinical development of SC-75416, a selective COX-2 inhibitor for the treatment of acute and chronic pain.Clin Pharm Ther. 2008;83:857-866.
-
(2008)
Clin Pharm Ther
, vol.83
, pp. 857-866
-
-
Kowalski, K.G.1
Olson, S.2
Remmers, A.E.3
Hutmacher, M.M.4
-
15
-
-
35949003229
-
A Bayesian approach for incorporating economic factors in sample size and design for clinical trials and portfolios of drugs
-
Patel NR,Ankolekar S.A Bayesian approach for incorporating economic factors in sample size and design for clinical trials and portfolios of drugs.Stat Med. 2007;26:4976-4988.
-
(2007)
Stat Med
, vol.26
, pp. 4976-4988
-
-
Patel, N.R.1
Ankolekar, S.2
-
16
-
-
33748576736
-
Adaptive, group sequential and decision theoretic approaches to sample size determination
-
Mehta CR,Patel NR.Adaptive, group sequential and decision theoretic approaches to sample size determination.Stat Med. 2006;25:3250-3269.
-
(2006)
Stat Med
, vol.25
, pp. 3250-3269
-
-
Mehta, C.R.1
Patel, N.R.2
-
17
-
-
33645987927
-
The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey
-
Torrance N,Smith BH,Bennett MI,Lee AJ.The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey.J Pain. 2006;7 (4): 281-289.
-
(2006)
J Pain
, vol.7
, Issue.4
, pp. 281-289
-
-
Torrance, N.1
Smith, B.H.2
Bennett, M.I.3
Lee, A.J.4
-
18
-
-
43549106321
-
Prevalence of chronic pain with neuropathic characteristics in the general population
-
Bouhassira D,Lantéri-Minet M,Attal N,Laurent B,Touboul C.Prevalence of chronic pain with neuropathic characteristics in the general population.Pain. 2008;136 (3): 380-387.
-
(2008)
Pain
, vol.136
, Issue.3
, pp. 380-387
-
-
Bouhassira, D.1
Lantéri-Minet, M.2
Attal, N.3
Laurent, B.4
Touboul, C.5
-
19
-
-
79851512653
-
Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain
-
Hewitt DJ,Ho TW,Galer B, et al.Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain.Pain. 2011;152 (3): 514-521.
-
(2011)
Pain
, vol.152
, Issue.3
, pp. 514-521
-
-
Hewitt, D.J.1
Ho, T.W.2
Galer, B.3
-
20
-
-
84873856788
-
-
January 24, Accessed March 27, 2012
-
EMA Neuropathic Pain guideline. January 24, 2007. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003478.pdf. Accessed March 27, 2012.
-
(2007)
EMA Neuropathic Pain guideline
-
-
-
21
-
-
70350619997
-
Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial
-
Chappell AS,Ossanna MJ,Liu-Seifert H, et al.Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial.Pain. 2009;146:253-260.
-
(2009)
Pain
, vol.146
, pp. 253-260
-
-
Chappell, A.S.1
Ossanna, M.J.2
Liu-Seifert, H.3
-
22
-
-
0033748343
-
Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and global assessments in patients with osteoarthritis
-
Ehrich EW,Davies GM,Watson DJ,Bolognese JA,Seidenberg BC,Bellamy N.Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and global assessments in patients with osteoarthritis.J Rheumatol. 2000;27 (11): 2635-2641.
-
(2000)
J Rheumatol
, vol.27
, Issue.11
, pp. 2635-2641
-
-
Ehrich, E.W.1
Davies, G.M.2
Watson, D.J.3
Bolognese, J.A.4
Seidenberg, B.C.5
Bellamy, N.6
-
23
-
-
36248961734
-
Innovative approaches for designing and analyzing adaptive dose-ranging trials (with discussion)
-
Bornkamp B,Bretz F,Dmitrienko A, et al.Innovative approaches for designing and analyzing adaptive dose-ranging trials (with discussion).J Biopharm Stat. 2007;17:965-995.
-
(2007)
J Biopharm Stat
, vol.17
, pp. 965-995
-
-
Bornkamp, B.1
Bretz, F.2
Dmitrienko, A.3
-
24
-
-
36248976637
-
Adaptive designs for dose-finding studies based on sigmoid Emax model
-
Dragalin V,Hsuan F,Padmanabhan SK.Adaptive designs for dose-finding studies based on sigmoid Emax model.J Biopharm Stat. 2007;17:1051-1070.
-
(2007)
J Biopharm Stat
, vol.17
, pp. 1051-1070
-
-
Dragalin, V.1
Hsuan, F.2
Padmanabhan, S.K.3
-
25
-
-
0022039941
-
Testing the statistical certainty of a response to increasing doses of a drug
-
Tukey JW,Ciminera JL,Heyse JF.Testing the statistical certainty of a response to increasing doses of a drug.Biometrics. 1985;41:295 301.
-
(1985)
Biometrics
, vol.41
, pp. 295-301
-
-
Tukey, J.W.1
Ciminera, J.L.2
Heyse, J.F.3
-
27
-
-
0019785890
-
Understanding the dose-effect relationship: clinical application of pharmacodynamic models
-
Holford N,Sheiner L.Understanding the dose-effect relationship: clinical application of pharmacodynamic models.Clin Pharmacokin. 1981;6:429-453.
-
(1981)
Clin Pharmacokin
, vol.6
, pp. 429-453
-
-
Holford, N.1
Sheiner, L.2
-
28
-
-
0035739149
-
Optimal design of dose response experiments: a model oriented approach
-
Fedorov VV,Leonov SL.Optimal design of dose response experiments: a model oriented approach.Drug Inf J. 2001;35:1373-1383.
-
(2001)
Drug Inf J
, vol.35
, pp. 1373-1383
-
-
Fedorov, V.V.1
Leonov, S.L.2
-
30
-
-
77958517231
-
A simulation study to compare new adaptive dose-ranging designs
-
Dragalin V,Bornkamp B,Bretz F, et al.A simulation study to compare new adaptive dose-ranging designs.Stat Biopharm Res. 2010;2 (4): 487-512.
-
(2010)
Stat Biopharm Res
, vol.2
, Issue.4
, pp. 487-512
-
-
Dragalin, V.1
Bornkamp, B.2
Bretz, F.3
-
31
-
-
36248951724
-
Optimal designs for estimating the interesting part of a dose-effect curve
-
Miller F,Guilbaud O,Dette H.Optimal designs for estimating the interesting part of a dose-effect curve.J Biopharm Stat. 2007;17:1097-1115.
-
(2007)
J Biopharm Stat
, vol.17
, pp. 1097-1115
-
-
Miller, F.1
Guilbaud, O.2
Dette, H.3
-
32
-
-
0041745823
-
-
2nd ed. New York, NY: John Wiley & Sons. 2003:119-171., New York, NY: John Wiley & Sons
-
Chib S.Subjective and Objective Bayesian Statistics: Principles, Models, and Applications. 2nd ed. New York, NY: John Wiley & Sons. 2003:119-171.New York, NY: John Wiley & Sons; 2003:119-171.
-
(2003)
Subjective and Objective Bayesian Statistics: Principles, Models, and Applications
, pp. 119-171
-
-
Chib, S.1
-
36
-
-
78249234519
-
-
available at, February 2010. Accessed March 27
-
Adaptive Design Clinical Trials for Drugs and Biologics. 2010, available athttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. February 2010. Accessed March 27, 2012.
-
(2010)
Adaptive Design Clinical Trials for Drugs and Biologics
-
-
|