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Volume 14, Issue 2

Journal of Biopharmaceutical Statistics

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Journal of Biopharmaceutical Statistics, Volume 14, Issue 2 (2004)

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Journal of Biopharmaceutical Statistics, Volume 14, Issue 2 (2004)

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Guest Editorial

Noninferiority and Equivalence Trials

Ivan S. F. Chan

Pages: 261-262

Published online: 02 Feb 2007

First Page PreviewforNoninferiority and Equivalence Trials | Full Text | PDF (77.5 KB)

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Original Articles

Article

Alternatives for Discounting in the Analysis of Noninferiority Trials

Steven M. Snapinn

Pages: 263-273

Published online: 02 Feb 2007

AbstractforAlternatives for Discounting in the Analysis of Noninferiority Trials | Full Text | References | PDF (148 KB)

188 Views
64 CrossRef citations
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Article

Lot Consistency as an Equivalence Problem

P. A. Lachenbruch, W. Rida & J. Kou

Pages: 275-290

Published online: 02 Feb 2007

AbstractforLot Consistency as an Equivalence Problem | Full Text | References | PDF (252.7 KB)

188 Views
10 CrossRef citations
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Article

A Bayesian Noninferiority Approach to Evaluation of Bridging Studies

Jen-Pei Liu, Hueymiin Hsueh & Chin-Fu Hsiao

Pages: 291-300

Published online: 02 Feb 2007

AbstractforA Bayesian Noninferiority Approach to Evaluation of Bridging Studies | Full Text | References | PDF (133.9 KB)

138 Views
15 CrossRef citations
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Article

Hypotheses and Type I Error in Active-Control Noninferiority Trials

Gang Chen, Yong-Cheng Wang & George YH. Chi

Pages: 301-313

Published online: 02 Feb 2007

AbstractforHypotheses and Type I Error in Active-Control Noninferiority Trials | Full Text | References | PDF (269.9 KB)

144 Views
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Article

Hypothesis Testing in the “Gold Standard” Design for Proving the Efficacy of an Experimental Treatment Relative to Placebo and a Reference

Armin Koch & Joachim Röhmel

Pages: 315-325

Published online: 02 Feb 2007

AbstractforHypothesis Testing in the “Gold Standard” Design for Proving the Efficacy of an Experimental Treatment Relative to Placebo and a Reference | Full Text | References | PDF (123.2 KB)

379 Views
62 CrossRef citations
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Article

Multiple Testing of Noninferiority Hypotheses in Active Controlled Trials

H. M. James Hung & Sue-Jane Wang

Pages: 327-335

Published online: 02 Feb 2007

AbstractforMultiple Testing of Noninferiority Hypotheses in Active Controlled Trials | Full Text | References | PDF (129.8 KB)

210 Views
25 CrossRef citations
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Article

Tests of Noninferiority via Rate Difference for Three-Arm Clinical Trials with Placebo

Man-Lai Tang & Nian-Sheng Tang

Pages: 337-347

Published online: 02 Feb 2007

AbstractforTests of Noninferiority via Rate Difference for Three-Arm Clinical Trials with Placebo | Full Text | References | PDF (138.5 KB)

193 Views
21 CrossRef citations
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Article

An Industry Survey on Current Practices in the Design and Analysis of Active Control Studies

Christy Chuang-Stein, Corsee Sanders & Steve Snapinn#

Pages: 349-358

Published online: 02 Feb 2007

AbstractforAn Industry Survey on Current Practices in the Design and Analysis of Active Control Studies | Full Text | References | PDF (113.3 KB)

67 Views
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Article

Group Sequential Design and Analysis of Clinical Equivalence Assessment for Generic Nonsystematic Drug Products

Yi Tsong, Juan (Joanne) Zhang & Sue Jane Wang

Pages: 359-373

Published online: 02 Feb 2007

AbstractforGroup Sequential Design and Analysis of Clinical Equivalence Assessment for Generic Nonsystematic Drug Products | Full Text | References | PDF (156.2 KB)

122 Views
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Article

Separate Modeling Approaches for Survival Analysis with Inaccurate Covariate Measurements

Cong Chen & Steven M. Snapinn

Pages: 375-387

Published online: 02 Feb 2007

AbstractforSeparate Modeling Approaches for Survival Analysis with Inaccurate Covariate Measurements | Full Text | References | PDF (146.7 KB)

44 Views
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Article

Two Simulation Methods for Constructing Confidence Bands Under the Additive Risk Model

Guosheng Yin & Jianhua Hu

Pages: 389-402

Published online: 02 Feb 2007

AbstractforTwo Simulation Methods for Constructing Confidence Bands Under the Additive Risk Model | Full Text | References | PDF (171.1 KB)

58 Views
4 CrossRef citations
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Article

Observation of Time-Dependent Adverse Events and the Influence of Drop-Out Thereon in Long-Term Safety Studies—Simulation Study Under the Current Practice of Post-marketing Safety Evaluation in Japan

Mamoru Narukawa, Akifumi Yafune & Masahiro Takeuchi

Pages: 403-414

Published online: 02 Feb 2007

AbstractforObservation of Time-Dependent Adverse Events and the Influence of Drop-Out Thereon in Long-Term Safety Studies—Simulation Study Under the Current Practice of Post-marketing Safety Evaluation in Japan | Full Text | References | PDF (146.9 KB)

65 Views
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Article

Measures of Morbidity in Clinical Studies with Recurrent Skeletal Complications

Joachim Moecks, Gary G. Koch, Martin Scott#, Michael Budde, Samuel Givens, Walter Koehler & Michael Knoessl†

Pages: 415-437

Published online: 02 Feb 2007

AbstractforMeasures of Morbidity in Clinical Studies with Recurrent Skeletal Complications | Full Text | References | PDF (184.1 KB)

49 Views
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Article

The Effect of the Heterogeneity Variance Estimator on Some Tests of Treatment Efficacy

Kepher H. Makambi

Pages: 439-449

Published online: 02 Feb 2007

AbstractforThe Effect of the Heterogeneity Variance Estimator on Some Tests of Treatment Efficacy | Full Text | References | PDF (141.3 KB)

125 Views
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Article

Simulating Titration to Goal Clinical Trials with Statins

Harry Southworth

Pages: 451-467

Published online: 02 Feb 2007

AbstractforSimulating Titration to Goal Clinical Trials with Statins | Full Text | References | PDF (171.7 KB)

42 Views
1 CrossRef citations
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Article

Confidence Interval of the Difference Between Two Proportions with Overdispersion

Cong Chen, Jianjun Li & Zhigang Zhou

Pages: 469-482

Published online: 02 Feb 2007

AbstractforConfidence Interval of the Difference Between Two Proportions with Overdispersion | Full Text | References | PDF (137.3 KB)

101 Views
1 CrossRef citations
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Article

Ordinary Differential Equation PK/PD Models Using the SAS Macro NLINMIX

Andrzej T. Galecki, Russell D. Wolfinger, Oscar A. Linares, Marla J. Smith & Jeffrey B. Halter

Pages: 483-503

Published online: 02 Feb 2007

AbstractforOrdinary Differential Equation PK/PD Models Using the SAS Macro NLINMIX | Full Text | References | PDF (199.6 KB)

198 Views
6 CrossRef citations
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Article

Conditional Bias of Point Estimates Following a Group Sequential Test

Xiaoyin (Frank) Fan, David L. DeMets & K. K. Gordon Lan

Pages: 505-530

Published online: 02 Feb 2007

AbstractforConditional Bias of Point Estimates Following a Group Sequential Test | Full Text | References | PDF (246.8 KB)

436 Views
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Miscellany

Book Review

Pages: 531-533

Published online: 02 Feb 2007

First Page PreviewforBook Review | Full Text | PDF (83.3 KB)

18 Views
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