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Therapeutic equivalence - Some comments
被引:1
作者
:
Bauer, P
论文数:
0
引用数:
0
h-index:
0
机构:
Inst Med Stat, A-1090 Vienna, Austria
Inst Med Stat, A-1090 Vienna, Austria
Bauer, P
[
1
]
机构
:
[1]
Inst Med Stat, A-1090 Vienna, Austria
来源
:
BIOMETRICAL JOURNAL
|
2005年
/ 47卷
/ 01期
关键词
:
D O I
:
10.1002/bimj.200410087
中图分类号
:
Q [生物科学];
学科分类号
:
07 ;
0710 ;
09 ;
摘要
:
[No abstract available]
引用
收藏
页码:99 / 103
页数:5
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Superior safety in noninferiority trials
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CAPIZZI T, 1996, DRUG INF J, V30, P949
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Methods for assessing noninferiority with censored data
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Biostatistical assessment of mutagenicity studies by including the positive control
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Statistical methods for the analysis of two-arm non-inferiority trials with binary outcomes
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←
1
→
共 9 条
[1]
Superior safety in noninferiority trials
[J].
Bristol, DR
论文数:
0
引用数:
0
h-index:
0
机构:
Purdue Pharma LP, Cranbury, NJ USA
Purdue Pharma LP, Cranbury, NJ USA
Bristol, DR
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:75
-81
[2]
CAPIZZI T, 1996, DRUG INF J, V30, P949
[3]
Methods for assessing noninferiority with censored data
[J].
Freitag, G
论文数:
0
引用数:
0
h-index:
0
机构:
Univ Gottingen, Inst Math Stochast, D-37073 Gottingen, Germany
Univ Gottingen, Inst Math Stochast, D-37073 Gottingen, Germany
Freitag, G
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:88
-98
[4]
Biostatistical assessment of mutagenicity studies by including the positive control
[J].
Hauschke, D
论文数:
0
引用数:
0
h-index:
0
机构:
Department of Biometry, Altana Pharma
Hauschke, D
;
Slacik-Erben, R
论文数:
0
引用数:
0
h-index:
0
机构:
Department of Biometry, Altana Pharma
Slacik-Erben, R
;
Hensen, S
论文数:
0
引用数:
0
h-index:
0
机构:
Department of Biometry, Altana Pharma
Hensen, S
;
Kaufmann, R
论文数:
0
引用数:
0
h-index:
0
机构:
Department of Biometry, Altana Pharma
Kaufmann, R
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:82
-87
[5]
A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials
[J].
Hung, HMJ
论文数:
0
引用数:
0
h-index:
0
机构:
US FDA, CDER, OPaSS, Div Biometr 1, Rockville, MD 20852 USA
Hung, HMJ
;
Wang, SJ
论文数:
0
引用数:
0
h-index:
0
机构:
US FDA, CDER, OPaSS, Div Biometr 1, Rockville, MD 20852 USA
Wang, SJ
;
O'Neill, R
论文数:
0
引用数:
0
h-index:
0
机构:
US FDA, CDER, OPaSS, Div Biometr 1, Rockville, MD 20852 USA
O'Neill, R
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:28
-36
[6]
Choice of delta: Requirements and reality - Results of a systematic review
[J].
Lange, S
论文数:
0
引用数:
0
h-index:
0
机构:
Inst Qual & Efficiency Hlth Care, D-51105 Cologne, Germany
Lange, S
;
Freitag, G
论文数:
0
引用数:
0
h-index:
0
机构:
Inst Qual & Efficiency Hlth Care, D-51105 Cologne, Germany
Freitag, G
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:12
-27
[7]
Problems with existing procedures to calculate exact unconditional p-values for non-inferiority/superiority and confidence intervals for two binomials and how to resolve them
[J].
Röhmel, J
论文数:
0
引用数:
0
h-index:
0
机构:
Bundesinst Arzneimittel & Med Prod, D-53175 Bonn, Germany
Bundesinst Arzneimittel & Med Prod, D-53175 Bonn, Germany
Röhmel, J
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:37
-47
[8]
Testing superiority and non-inferiority hypotheses in active controlled clinical trials
[J].
Tsong, Y
论文数:
0
引用数:
0
h-index:
0
机构:
US FDA, CDER, OPaSS, Off Biostat, Rockville, MD 20857 USA
US FDA, CDER, OPaSS, Off Biostat, Rockville, MD 20857 USA
Tsong, Y
;
Zhang, J
论文数:
0
引用数:
0
h-index:
0
机构:
US FDA, CDER, OPaSS, Off Biostat, Rockville, MD 20857 USA
US FDA, CDER, OPaSS, Off Biostat, Rockville, MD 20857 USA
Zhang, J
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:62
-74
[9]
Statistical methods for the analysis of two-arm non-inferiority trials with binary outcomes
[J].
论文数:
引用数:
h-index:
机构:
Wellek, S
.
BIOMETRICAL JOURNAL,
2005,
47
(01)
:48
-61
←
1
→