-
1
-
-
43749086220
-
"Simple, Defensible Sample Sizes Based on Cost Efficiency" (with discussion)
-
Bacchetti, P., McCulloch, C. E. and Segal, M. R. 2008. "Simple, Defensible Sample Sizes Based on Cost Efficiency" (with discussion). Biometrics, 64: 577 - 594.
-
(2008)
Biometrics
, vol.64
, pp. 577-594
-
-
Bacchetti, P.1
McCulloch, C.E.2
Segal, M.R.3
-
2
-
-
0028619850
-
Evaluation of Experiments With Adaptive Interim Analyses
-
Bauer, P. and Kohne, K. 1994. Evaluation of Experiments With Adaptive Interim Analyses. Biometrics, 50: 1029 - 1041.
-
(1994)
Biometrics
, vol.50
, pp. 1029-1041
-
-
Bauer, P.1
Kohne, K.2
-
3
-
-
33646260128
-
"Are Flexible Designs Sound?" (with discussion)
-
Burman, C. F. and Sonesson, C. 2006. "Are Flexible Designs Sound?" (with discussion). Biometrics, 62: 664 - 683.
-
(2006)
Biometrics
, vol.62
, pp. 664-683
-
-
Burman, C.F.1
Sonesson, C.2
-
4
-
-
0003421882
-
-
2nd ed., Boca Raton, FL, Boca Raton, FL,: Chapman & Hall/CRC
-
Collett, D. 2003. Modelling Survival Data in Medical Research, 2nd ed., Boca Raton, FL: Chapman & Hall/CRC.
-
(2003)
Modelling Survival Data in Medical Research
-
-
Collett, D.1
-
6
-
-
65649090527
-
Consequences of Dichotomization
-
Fedorov, V., Mannino, F. and Zhang, R. 2009. Consequences of Dichotomization. Pharmaceutical Statistics, 8: 50 - 61.
-
(2009)
Pharmaceutical Statistics
, vol.8
, pp. 50-61
-
-
Fedorov, V.1
Mannino, F.2
Zhang, R.3
-
7
-
-
0032581580
-
Self-Designing Clinical Trials
-
Fisher, L. D. 1998. Self-Designing Clinical Trials. Statistics in Medicine, 17: 1551 - 1562.
-
(1998)
Statistics in Medicine
, vol.17
, pp. 1551-1562
-
-
Fisher, L.D.1
-
8
-
-
33646245937
-
Adaptive Designs in Clinical Drug Development-An Executive Summary of the PhRMA Working Group
-
PhRMA Working Group, discussion 285-291, 293-278, 311-272
-
Gallo, P., Chuang-Stein, C., Dragalin, V., Gaydos, B., Krams, M., Pinheiro, J. and PhRMA Working Group. 2006. Adaptive Designs in Clinical Drug Development-An Executive Summary of the PhRMA Working Group. Journal of Biopharmaceutical Statistics, 16: 275 - 283. discussion 285-291, 293-278, 311-272
-
(2006)
Journal of Biopharmaceutical Statistics
, vol.16
, pp. 275-283
-
-
Gallo, P.1
Chuang-Stein, C.2
Dragalin, V.3
Gaydos, B.4
Krams, M.5
Pinheiro, J.6
-
10
-
-
33748519263
-
A Regulatory View on Adaptive/Flexible Clinical Trial Design
-
Hung, H. M., O'Neill, R. T., Wang, S. J. and Lawrence, J. 2006. A Regulatory View on Adaptive/Flexible Clinical Trial Design. Biometrical Journal Biometrische Zeitschrift, 48: 565 - 573.
-
(2006)
Biometrical Journal Biometrische Zeitschrift
, vol.48
, pp. 565-573
-
-
Hung, H.M.1
O'Neill, R.T.2
Wang, S.J.3
Lawrence, J.4
-
11
-
-
0033566769
-
Statistical Principles for Clinical Trials (ICH E9)
-
International Conference on Harmonisation
-
International Conference on Harmonisation. 1999. Statistical Principles for Clinical Trials (ICH E9). Statistics in Medicine, 18: 1905 - 1942.
-
(1999)
Statistics in Medicine
, vol.18
, pp. 1905-1942
-
-
-
12
-
-
50549104256
-
Why Most Discovered True Associations Are Inflated
-
Ioannidis, J. P. 2008. Why Most Discovered True Associations Are Inflated. Epidemiology, 19: 640 - 648.
-
(2008)
Epidemiology
, vol.19
, pp. 640-648
-
-
Ioannidis, J.P.1
-
13
-
-
33846563409
-
Why Most Published Research Findings Are False
-
---. 2005. Why Most Published Research Findings Are False. PLoS Medicine, 2: 696 - 701.
-
(2005)
PLoS Medicine
, vol.2
, pp. 696-701
-
-
-
14
-
-
4544335467
-
Translation of Pharmacogenomics and Pharmacogenetics: A Regulatory Perspective
-
Lesko, L. J. and Woodcock, J. 2004. Translation of Pharmacogenomics and Pharmacogenetics: A Regulatory Perspective. Nature Reviews Drug Discovery, 3: 763 - 769.
-
(2004)
Nature Reviews Drug Discovery
, vol.3
, pp. 763-769
-
-
Lesko, L.J.1
Woodcock, J.2
-
15
-
-
0347419694
-
Clinical Trials-Statistical Developments of Practical Benefit to the Pharmaceutical Industry
-
Lewis, J. A. 1983. Clinical Trials-Statistical Developments of Practical Benefit to the Pharmaceutical Industry. Journal of the Royal Statistical Society, Series A, 146: 362 - 393.
-
(1983)
Journal of the Royal Statistical Society, Series A
, vol.146
, pp. 362-393
-
-
Lewis, J.A.1
-
16
-
-
10644246879
-
In Defence of the Dichotomy
-
Lewis, J. A. 2004. In Defence of the Dichotomy. Pharmaceutical Statistics, 3: 77 - 79.
-
(2004)
Pharmaceutical Statistics
, vol.3
, pp. 77-79
-
-
Lewis, J.A.1
-
17
-
-
0029164844
-
Biostatistical Methodology in Clinical Trials-A European Guideline
-
Lewis, J. A., Jones, D. R. and Röhmel, J. 1995. Biostatistical Methodology in Clinical Trials-A European Guideline. Statistics in Medicine, 14: 1655 - 1657.
-
(1995)
Statistics in Medicine
, vol.14
, pp. 1655-1657
-
-
Lewis, J.A.1
Jones, D.R.2
Röhmel, J.3
-
18
-
-
33748543260
-
Adaptive vs. Group Sequential Self-Designing Trials (with discussion)
-
Mehrotra, D. V. and Fan, X. 2006. "Adaptive vs. Group Sequential Self-Designing Trials" (with discussion). Biometrical Journal Biometrische Zeitschrift, 48: 710 - 713.
-
(2006)
Biometrical Journal Biometrische Zeitschrift
, vol.48
, pp. 710-713
-
-
Mehrotra, D.V.1
Fan, X.2
-
19
-
-
84884310373
-
The Biometrical Role in United States Drug Regulation
-
In: Vollmar J., editors Stuttgart, Stuttgart,: Gustav Fischer
-
O'Neill, R. T. 1991. " The Biometrical Role in United States Drug Regulation ". In Biometri in Der Chemisch-Pahramzuetischen Industrie, Edited by: Vollmar, J. 31 - 42. Stuttgart: Gustav Fischer.
-
(1991)
Biometri in Der Chemisch-Pahramzuetischen Industrie
, pp. 31-42
-
-
O'Neill, R.T.1
-
20
-
-
33748570794
-
FDA's Critical Path Initiative: A Perspective on Contributions of Biostatistics
-
---. 2006. FDA's Critical Path Initiative: A Perspective on Contributions of Biostatistics. Biometrical Journal Biometrische Zeitschrift, 48: 559 - 564.
-
(2006)
Biometrical Journal Biometrische Zeitschrift
, vol.48
, pp. 559-564
-
-
-
21
-
-
0015940278
-
Computer-Assisted Digoxin Therapy
-
Peck, C. C., Sheiner, L. B., Martin, C. M., Combs, D. T. and Melmon, K. L. 1973. Computer-Assisted Digoxin Therapy. New England Journal of Medicine, 289: 441 - 446.
-
(1973)
New England Journal of Medicine
, vol.289
, pp. 441-446
-
-
Peck, C.C.1
Sheiner, L.B.2
Martin, C.M.3
Combs, D.T.4
Melmon, K.L.5
-
22
-
-
0006778240
-
Statistics and Statisticians in Drug Regulation in the United Kingdom
-
Pocock, S., Altman, D., Armitage, P., Ashby, D., Bland, M., Chilvers, C., Dawid, P., Ebbutt, A., Evans, S., Finney, D., Gardner, M., Gore, S., Jones, D., Lewis, J., Machin, D., Matthews, J., Spiegelhalter, D., Sutherland, I. and Thompson, S. 1991. Statistics and Statisticians in Drug Regulation in the United Kingdom. Journal of the Royal Statistical Society, Series A, 154: 413 - 419.
-
(1991)
Journal of the Royal Statistical Society, Series A
, vol.154
, pp. 413-419
-
-
Pocock, S.1
Altman, D.2
Armitage, P.3
Ashby, D.4
Bland, M.5
Chilvers, C.6
Dawid, P.7
Ebbutt, A.8
Evans, S.9
Finney, D.10
Gardner, M.11
Gore, S.12
Jones, D.13
Lewis, J.14
Machin, D.15
Matthews, J.16
Spiegelhalter, D.17
Sutherland, I.18
Thompson, S.19
-
23
-
-
0033586193
-
"Trials Stopped Early: Too Good to Be True?" (comment)
-
Pocock, S. J. and White, I. 1999. "Trials Stopped Early: Too Good to Be True?" (comment). Lancet, 353: 943 - 944.
-
(1999)
Lancet
, vol.353
, pp. 943-944
-
-
Pocock, S.J.1
White, I.2
-
24
-
-
0029589385
-
Designed Extension of Studies Based on Conditional Power
-
Proschan, M. A. and Hunsberger, S. A. 1995. Designed Extension of Studies Based on Conditional Power. Biometrics, 51: 1315 - 1324.
-
(1995)
Biometrics
, vol.51
, pp. 1315-1324
-
-
Proschan, M.A.1
Hunsberger, S.A.2
-
25
-
-
0002008937
-
Bayesian Methods in Practice-Experiences in the Pharmaceutical Industry
-
Series C
-
Racine, A., Grieve, A. P., Fluhler, H. and Smith, A. F.M. 1986. Bayesian Methods in Practice-Experiences in the Pharmaceutical Industry. Journal of the Royal Statistical Society, 35: 93 - 150. Series C
-
(1986)
Journal of the Royal Statistical Society
, vol.35
, pp. 93-150
-
-
Racine, A.1
Grieve, A.P.2
Fluhler, H.3
Smith, A.F.M.4
-
26
-
-
0026583274
-
Is the 'Simple Carry-Over' Model Useful?
-
Senn, S. J. 1992. Is the 'Simple Carry-Over' Model Useful?. Statistics in Medicine, 11: 715 - 726.
-
(1992)
Statistics in Medicine
, vol.11
, pp. 715-726
-
-
Senn, S.J.1
-
27
-
-
0032558244
-
Applying Results of Randomised Trials to Patients. N of 1 Trials Are Needed (letter; comment)
-
Senn, S. J. 1998. "Applying Results of Randomised Trials to Patients. N of 1 Trials Are Needed" (letter; comment),. British Medical Journal, 317: 537 - 538.
-
(1998)
British Medical Journal
, vol.317
, pp. 537-538
-
-
Senn, S.J.1
-
28
-
-
0347807759
-
Consensus and Controversy in Pharmaceutical Statistics (with discussion)
-
Senn, S. J. 2000. "Consensus and Controversy in Pharmaceutical Statistics" (with discussion),. The Statistician, 49: 135 - 176.
-
(2000)
The Statistician
, vol.49
, pp. 135-176
-
-
Senn, S.J.1
-
29
-
-
0035739148
-
Individual Therapy: New Dawn or False Dawn
-
Senn, S. J. 2001. Individual Therapy: New Dawn or False Dawn. Drug Information Journal, 35: 1479 - 1494.
-
(2001)
Drug Information Journal
, vol.35
, pp. 1479-1494
-
-
Senn, S.J.1
-
30
-
-
10644253180
-
Disappointing Dichotomies
-
Senn, S. J. 2003. Disappointing Dichotomies. Pharmaceutical Statistics, 2: 239 - 240.
-
(2003)
Pharmaceutical Statistics
, vol.2
, pp. 239-240
-
-
Senn, S.J.1
-
31
-
-
16644391425
-
Added Values: Controversies Concerning Randomization and Additivity in Clinical Trials
-
Senn, S. J. 2004a. Added Values: Controversies Concerning Randomization and Additivity in Clinical Trials. Statistics in Medicine, 23: 3729 - 3753.
-
(2004)
Statistics in Medicine
, vol.23
, pp. 3729-3753
-
-
Senn, S.J.1
-
32
-
-
6944230023
-
Individual Response to Treatment: Is It a Valid Assumption?
-
Senn, S. J. 2004b. Individual Response to Treatment: Is It a Valid Assumption?. British Medical Journal, 329: 966 - 968.
-
(2004)
British Medical Journal
, vol.329
, pp. 966-968
-
-
Senn, S.J.1
-
33
-
-
21244471029
-
An Unreasonable Prejudice Against Modelling?
-
Senn, S. J. 2005. An Unreasonable Prejudice Against Modelling?. Pharmaceutical Statistics, 4: 87 - 89.
-
(2005)
Pharmaceutical Statistics
, vol.4
, pp. 87-89
-
-
Senn, S.J.1
-
35
-
-
77955922547
-
Statisticians and Pharmacokineticists: What They Can Still Learn From Each Other
-
Senn, S. J. 2010. Statisticians and Pharmacokineticists: What They Can Still Learn From Each Other. Clinical Pharmacology & Therapeutics, 88: 328 - 334.
-
(2010)
Clinical Pharmacology & Therapeutics
, vol.88
, pp. 328-334
-
-
Senn, S.J.1
-
36
-
-
84865116058
-
U Is for Unease: Reasons to Mistrust Overlap Measures in Clinical Trials
-
Senn, S. J. 2011. U Is for Unease: Reasons to Mistrust Overlap Measures in Clinical Trials. Statistics in Biopharmaceutical Research, 3: 302 - 309.
-
(2011)
Statistics in Biopharmaceutical Research
, vol.3
, pp. 302-309
-
-
Senn, S.J.1
-
37
-
-
70449369661
-
Measurement in Clinical Trials: A Neglected Issue for Statisticians?
-
Senn, S. J. and Julious, S. 2009. Measurement in Clinical Trials: A Neglected Issue for Statisticians?. Statistics in Medicine, 28: 3189 - 3209.
-
(2009)
Statistics in Medicine
, vol.28
, pp. 3189-3209
-
-
Senn, S.J.1
Julious, S.2
-
38
-
-
0025743320
-
"The Intellectual Health of Clinical Drug Evaluation" (comment)
-
Sheiner, L. B. 1991. "The Intellectual Health of Clinical Drug Evaluation" (comment). Clinical Pharmacology & Therapeutics, 50: 4 - 9.
-
(1991)
Clinical Pharmacology & Therapeutics
, vol.50
, pp. 4-9
-
-
Sheiner, L.B.1
-
39
-
-
0015405814
-
Modelling of Individual Pharmacokinetics for Computer-Aided Drug Dosage
-
Sheiner, L. B., Rosenberg, B. and Melmon, K. L. 1972. Modelling of Individual Pharmacokinetics for Computer-Aided Drug Dosage. Computers and Biomedical Research, 5: 411 - 459.
-
(1972)
Computers and Biomedical Research
, vol.5
, pp. 411-459
-
-
Sheiner, L.B.1
Rosenberg, B.2
Melmon, K.L.3
-
40
-
-
0004103373
-
The Pharmaceutical Industry in the New Millennium: Capturing the Scientific Promise
-
Technical lecture, London: Centre for Medicines Research
-
Sykes, R. 1997. The Pharmaceutical Industry in the New Millennium: Capturing the Scientific Promise. Technical lecture, London: Centre for Medicines Research
-
(1997)
-
-
Sykes, R.1
-
41
-
-
0032585221
-
Being a Modern Pharmaceutical Company Involves Making Information Available on Clinical Trial Programmes
-
Sykes, R. 1998. Being a Modern Pharmaceutical Company Involves Making Information Available on Clinical Trial Programmes. British Medical Journal, 317: 1172
-
(1998)
British Medical Journal
, vol.317
, pp. 1172
-
-
Sykes, R.1
-
42
-
-
33749322274
-
"Information-Based Monitoring of Clinical Trials" (with discussion)
-
discussion 3320-3325, 3326-3347
-
Tsiatis, A. A. 2006. "Information-Based Monitoring of Clinical Trials" (with discussion). Statistics in Medicine, 25: 3236 - 3244. discussion 3320-3325, 3326-3347
-
(2006)
Statistics in Medicine
, vol.25
, pp. 3236-3244
-
-
Tsiatis, A.A.1
-
43
-
-
0036040466
-
The Odds of the Three Nons When an Aptly Prescribed Medicine Isn't Working: Non-Compliance, Non-Absorption, Non-Response
-
Urquhart, J. 2002. The Odds of the Three Nons When an Aptly Prescribed Medicine Isn't Working: Non-Compliance, Non-Absorption, Non-Response. British Journal of Clinical Pharmacology, 54: 212 - 220.
-
(2002)
British Journal of Clinical Pharmacology
, vol.54
, pp. 212-220
-
-
Urquhart, J.1
-
44
-
-
33745173819
-
Adapting the Sample Size Planning of a Phase III Trial Based on Phase II Data
-
Wang, S. J., Hung, H. M. and O'Neill, R. T. 2006. Adapting the Sample Size Planning of a Phase III Trial Based on Phase II Data. Pharmaceutical Statistics, 5: 85 - 97.
-
(2006)
Pharmaceutical Statistics
, vol.5
, pp. 85-97
-
-
Wang, S.J.1
Hung, H.M.2
O'Neill, R.T.3
-
45
-
-
66349125688
-
Adaptive Patient Enrichment Designs in Therapeutic Trials
-
Wang, S. J., Hung, H. M. and O'Neill, R. T. 2009. Adaptive Patient Enrichment Designs in Therapeutic Trials. Biometrical Journal Biometrische Zeitschrift, 51: 358 - 374.
-
(2009)
Biometrical Journal Biometrische Zeitschrift
, vol.51
, pp. 358-374
-
-
Wang, S.J.1
Hung, H.M.2
O'Neill, R.T.3
-
46
-
-
78751608557
-
Adaptive Design Clinical Trials and Trial Logistics Models in CNS Drug Development
-
Wang, S. J., Hung, H. M. and O'Neill, R. T. 2011. Adaptive Design Clinical Trials and Trial Logistics Models in CNS Drug Development. European Neuropsychopharmacology, 21: 159 - 166.
-
(2011)
European Neuropsychopharmacology
, vol.21
, pp. 159-166
-
-
Wang, S.J.1
Hung, H.M.2
O'Neill, R.T.3
|