Works matching IS 03233847 AND DT 2005 AND VI 47 AND IP 1
Results: 13
Statistical Methods for the Analysis of Two-Arm Non-inferiority Trials with Binary Outcomes.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 48
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Testing Superiority and Non-Inferiority Hypotheses in Active Controlled Clinical TrialsThis paper does not represent the official position of the Food and Drug Administration.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 62
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Editorial: Biom. J. 1/2005.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 5
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A Tribute to Joachim Röhmel upon his retirement from the Federal Institute of Drugs.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 10
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‘Equivalence is Different’ – Some Comments on Therapeutic Equivalence.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 104
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Therapeutic Equivalence – Clinical Issues and Statistical Methodology in Noninferiority Trials.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 7
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Therapeutic Equivalence – Some Comments.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 99
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- Article
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.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 37
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Special Invited Papers Section: Therapeutic Equivalence – Clinical Issues and Statistical Methodology in Noninferiority Trials: Choice of Delta: Requirements and Reality – Results of a Systematic Review.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 12
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A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non-inferiority TrialsThe views expressed in this article do not necessarily represent those of the U.S. Food and Drug Administration.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 28
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Methods for Assessing Noninferiority with Censored Data.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 88
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Biostatistical Assessment of Mutagenicity Studies by Including the Positive Control.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 82
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Superior Safety in Noninferiority Trials.
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- Biometrical Journal, 2005, v. 47, n. 1, p. 75
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- Article