-
1
-
-
85031148239
-
-
Rockville, Maryland: Food and Drug Administration Center for Drug Evaluation and Research
-
Guidance for industry: developing antimicrobial drugs-general considerations for clinical trials. 1998;Food and Drug Administration Center for Drug Evaluation and Research, Rockville, Maryland.
-
(1998)
-
-
-
2
-
-
0034669484
-
Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: Results of a North American multicenter randomized trial
-
Nabholtz J.M., Buzdar A., Pollak M., et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. J Clin Oncol. 18:2000;3758-3767.
-
(2000)
J Clin Oncol
, vol.18
, pp. 3758-3767
-
-
Nabholtz, J.M.1
Buzdar, A.2
Pollak, M.3
-
3
-
-
0035868896
-
Equivalence of three or four cycles of bleomycin, etoposide, and cisplatin chemotherapy and of a 3- or 5-day schedule in good-prognosis germ cell cancer: A randomized study of the European organization for research and treatment of
-
Wit R.D., Roberts J.T., Wilkinson P.M., et al. Equivalence of three or four cycles of bleomycin, etoposide, and cisplatin chemotherapy and of a 3- or 5-day schedule in good-prognosis germ cell cancer: a randomized study of the European organization for research and treatment of. J Clin Oncol. 19:2001;1619-1640.
-
(2001)
J Clin Oncol
, vol.19
, pp. 1619-1640
-
-
Wit, R.D.1
Roberts, J.T.2
Wilkinson, P.M.3
-
4
-
-
0033016189
-
A trial comparing low-dose, short-course ciprofloxacin and standard 7 day therapy with co-trimoxazole or nitrofurantoin in the treatment of uncomplicated urinary tract infection
-
Iravani A., Klimberg I., Briefer C., et al. A trial comparing low-dose, short-course ciprofloxacin and standard 7 day therapy with co-trimoxazole or nitrofurantoin in the treatment of uncomplicated urinary tract infection. J Antimicrob Chemother. 43:(Suppl A):1999;67-75.
-
(1999)
J Antimicrob Chemother
, vol.43
, Issue.SUPPL. A
, pp. 67-75
-
-
Iravani, A.1
Klimberg, I.2
Briefer, C.3
-
5
-
-
0033105747
-
A randomized trial of short-course ciprofloxacin, ofloxacin or trimethoprim/sulfamethoxazole for the treatment of acute urinary tract infection in women
-
McCarty J.M., Richard G., Huck W., et al. A randomized trial of short-course ciprofloxacin, ofloxacin or trimethoprim/sulfamethoxazole for the treatment of acute urinary tract infection in women. Am J Med. 106:1999;292-299.
-
(1999)
Am J Med
, vol.106
, pp. 292-299
-
-
McCarty, J.M.1
Richard, G.2
Huck, W.3
-
6
-
-
0032528867
-
Practical issues in equivalence trials
-
Ebbutt A.F., Frith L. Practical issues in equivalence trials. Stat Med. 17:1998;1691-1701.
-
(1998)
Stat Med
, vol.17
, pp. 1691-1701
-
-
Ebbutt, A.F.1
Frith, L.2
-
7
-
-
0032529072
-
Therapeutic equivalence investigations: Statistical considerations
-
Rõhmel J. Therapeutic equivalence investigations: statistical considerations. Stat Med. 17:1997;1703-1714.
-
(1997)
Stat Med
, vol.17
, pp. 1703-1714
-
-
Rõhmel, J.1
-
8
-
-
0034891308
-
Sample size determination for equivalence test using rate ratio of sensitivity and specificity in paired sample size
-
Lui K.J., Cumberland W.G. Sample size determination for equivalence test using rate ratio of sensitivity and specificity in paired sample size. Control Clin Trials. 22:2001;373-389.
-
(2001)
Control Clin Trials
, vol.22
, pp. 373-389
-
-
Lui, K.J.1
Cumberland, W.G.2
-
9
-
-
0036174274
-
Showing a treatment is good because it is not bad: When does "noninferiority" imply effectiveness?
-
Blackwelder W.C. Showing a treatment is good because it is not bad: when does "noninferiority" imply effectiveness? Control Clin Trials. 23:2002;52-54.
-
(2002)
Control Clin Trials
, vol.23
, pp. 52-54
-
-
Blackwelder, W.C.1
-
11
-
-
0021566165
-
Power and sample size for a collection of 2×2 tables
-
Munoz A., Rosner B. Power and sample size for a collection of 2×2 tables. Biometrics. 40:1984;995-1004.
-
(1984)
Biometrics
, vol.40
, pp. 995-1004
-
-
Munoz, A.1
Rosner, B.2
-
12
-
-
0022964981
-
Sample size for case-control studies using Cochran's statistic
-
Woolson R.F., Bean J.A., Rojas B.P. Sample size for case-control studies using Cochran's statistic. Biometrics. 42:1986;927-932.
-
(1986)
Biometrics
, vol.42
, pp. 927-932
-
-
Woolson, R.F.1
Bean, J.A.2
Rojas, B.P.3
-
13
-
-
0009734893
-
The power of the Mantel-Haenszel test
-
Wittes J., Wallenstein S. The power of the Mantel-Haenszel test. JASA. 82:1987;1104-1109.
-
(1987)
JASA
, vol.82
, pp. 1104-1109
-
-
Wittes, J.1
Wallenstein, S.2
-
14
-
-
84959801619
-
Statistical aspects of the analysis of data from retrospective studies of disease
-
Mantel N., Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Nat Cancer Inst. 22:1959;719-748.
-
(1959)
J Nat Cancer Inst
, vol.22
, pp. 719-748
-
-
Mantel, N.1
Haenszel, W.2
-
15
-
-
0020308864
-
"Proving the Null Hypothesis" in clinical trials
-
Blackwelder W.C. "Proving the Null Hypothesis" in clinical trials. Control Clin Trials. 3:1982;345-353.
-
(1982)
Control Clin Trials
, vol.3
, pp. 345-353
-
-
Blackwelder, W.C.1
-
16
-
-
0025633361
-
Test statistics and sample size formulae for comparative binomial trials with null hypothesis on non-zero risk difference or non-unity relative risk
-
Farrington C.P., Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis on non-zero risk difference or non-unity relative risk. Stat Med. 9:1990;1447-1454.
-
(1990)
Stat Med
, vol.9
, pp. 1447-1454
-
-
Farrington, C.P.1
Manning, G.2
-
17
-
-
0029089457
-
Sample size determination in stratified trials to establish the equivalence of two treatments
-
Nam J.M. Sample size determination in stratified trials to establish the equivalence of two treatments. Stat Med. 14:1995;2037-2049.
-
(1995)
Stat Med
, vol.14
, pp. 2037-2049
-
-
Nam, J.M.1
-
18
-
-
0029791072
-
Power determination for geographically clustered data using generalized estimating equations
-
Hendricks S.A., Wassell J.T., Collins J.W., Sedlak S.L. Power determination for geographically clustered data using generalized estimating equations. Stat Med. 15:1996;1951-1960.
-
(1996)
Stat Med
, vol.15
, pp. 1951-1960
-
-
Hendricks, S.A.1
Wassell, J.T.2
Collins, J.W.3
Sedlak, S.L.4
-
19
-
-
0000176510
-
Categorical data analysis
-
D.A. Berry. New York: Marcel Dekker Inc
-
Koch G.G., Carr G.J., Amara I.A., Stokes M.E., Uryniak T.J. Categorical data analysis. Berry D.A. Statistical methodology in the pharmaceutical science. 1990;Marcel Dekker Inc, New York.
-
(1990)
Statistical methodology in the pharmaceutical science
-
-
Koch, G.G.1
Carr, G.J.2
Amara, I.A.3
Stokes, M.E.4
Uryniak, T.J.5
-
21
-
-
0036169283
-
Choosing an equivalence limit for noninferiority or equivalence studies
-
Wiens B.L. Choosing an equivalence limit for noninferiority or equivalence studies. Control Clin Trials. 23:2002;2-14.
-
(2002)
Control Clin Trials
, vol.23
, pp. 2-14
-
-
Wiens, B.L.1
-
22
-
-
0021832508
-
Comparative analysis of two rates
-
Miettinen O., Nurminen M. Comparative analysis of two rates. Stat Med. 4:1985;213-226.
-
(1985)
Stat Med
, vol.4
, pp. 213-226
-
-
Miettinen, O.1
Nurminen, M.2
-
23
-
-
0025133587
-
Approximate interval estimation of the difference in binomial parameters: Correction for skewness and extension to multiple tables
-
Gart J.J., Nam J. Approximate interval estimation of the difference in binomial parameters: correction for skewness and extension to multiple tables. Biometrics. 46:1990;637-643.
-
(1990)
Biometrics
, vol.46
, pp. 637-643
-
-
Gart, J.J.1
Nam, J.2
-
24
-
-
0036013103
-
Cluster randomization trials: A simulation study
-
Song J.X., Chul A. Cluster randomization trials: a simulation study. Biometrical Journal. 44:2002;375-390.
-
(2002)
Biometrical Journal
, vol.44
, pp. 375-390
-
-
Song, J.X.1
Chul, A.2
-
25
-
-
0037772413
-
An evaluation of methods for the stratified analysis of clustered binary data in community intervention trials
-
Song J.X., Chul W.A. An evaluation of methods for the stratified analysis of clustered binary data in community intervention trials. Stat Med. 13:2003;2205-2216.
-
(2003)
Stat Med
, vol.13
, pp. 2205-2216
-
-
Song, J.X.1
Chul, W.A.2
-
26
-
-
0024266392
-
Correlated binary regression with covariates specific to each binary observation
-
Prentice R.L. Correlated binary regression with covariates specific to each binary observation. Biometrics. 44:1988;1033-1048.
-
(1988)
Biometrics
, vol.44
, pp. 1033-1048
-
-
Prentice, R.L.1
-
27
-
-
0032528974
-
Methodological advances and plans for improving regulatory success for confirmatory studies
-
Koch G.G., Davis S.M., Anderson R.L. Methodological advances and plans for improving regulatory success for confirmatory studies. Stat Med. 17:1998;1675-1690.
-
(1998)
Stat Med
, vol.17
, pp. 1675-1690
-
-
Koch, G.G.1
Davis, S.M.2
Anderson, R.L.3
-
28
-
-
0028957828
-
A simple measure in defining optimal strata in clinical trials
-
Choi S.C., Germanson T.P. A simple measure in defining optimal strata in clinical trials. Control Clin Trials. 16:1995;164-171.
-
(1995)
Control Clin Trials
, vol.16
, pp. 164-171
-
-
Choi, S.C.1
Germanson, T.P.2
-
29
-
-
0023248602
-
Adjustments to the Mantel-Haenszel chi-sqare statistic and odds ratio variance estimator when the data are clustered
-
Donald A., Donner A.A. Adjustments to the Mantel-Haenszel chi-sqare statistic and odds ratio variance estimator when the data are clustered. Stat Med. 6:1987;491-499.
-
(1987)
Stat Med
, vol.6
, pp. 491-499
-
-
Donald, A.1
Donner, A.A.2
-
30
-
-
0026471177
-
Correlated binomial variates: Properties of estimator of intraclass correlation and its effect on sample size calculation
-
Feng Z.D., Grizzle J.E. Correlated binomial variates: properties of estimator of intraclass correlation and its effect on sample size calculation. Stat Med. 11:1992;1607-1614.
-
(1992)
Stat Med
, vol.11
, pp. 1607-1614
-
-
Feng, Z.D.1
Grizzle, J.E.2
-
31
-
-
0001793141
-
Combination of results from several 2×2 contingency tables
-
Radhakrishna S. Combination of results from several 2×2 contingency tables. Biometrics. 21:1965;86-98.
-
(1965)
Biometrics
, vol.21
, pp. 86-98
-
-
Radhakrishna, S.1
-
32
-
-
0026539350
-
Sample size requirements for stratified cluster randomization designs
-
Donner A. Sample size requirements for stratified cluster randomization designs. Stat Med. 11:1992;743-750.
-
(1992)
Stat Med
, vol.11
, pp. 743-750
-
-
Donner, A.1
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