Journal of Biopharmaceutical Statistics, Volume 23, Issue 1 (2013)

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Journal of Biopharmaceutical Statistics, Volume 23, Issue 1 (2013)

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Medical Product Safety

Editorials

Editorial
Editors' Note on Special Issue on Medical Product Safety
Yi Tsong & Jie Chen
Pages: 1-2
Published online: 18 Jan 2013
CitationforEditors' Note on Special Issue on Medical Product Safety | Full Text | PDF (48.8 KB)
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Original Articles

Article
The Practice of Pre-Marketing Safety Assessment in Drug Development
Christy Chuang-Stein & H. Amy Xia
Pages: 3-25
Published online: 18 Jan 2013
AbstractforThe Practice of Pre-Marketing Safety Assessment in Drug Development | Full Text | References | PDF (224.1 KB)
  • 697 Views
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Article
Identifying Potential Adverse Events Dose-Response Relationships Via Bayesian Indirect and Mixed Treatment Comparison Models
Haoda Fu, Karen L. Price, Mary E. Nilsson & Stephen J. Ruberg
Pages: 26-42
Published online: 18 Jan 2013
AbstractforIdentifying Potential Adverse Events Dose-Response Relationships Via Bayesian Indirect and Mixed Treatment Comparison Models | Full Text | References | PDF (449.3 KB)
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Article
On the Designs of Thorough QT/QTc Clinical Trials
Yi Tsong
Pages: 43-56
Published online: 18 Jan 2013
AbstractforOn the Designs of Thorough QT/QTc Clinical Trials | Full Text | References | PDF (757.5 KB)
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Article
Sample Size of Thorough QTc Clinical Trial Adjusted for Multiple Comparisons
Yi Tsong, Anna Sun & Seung-Ho Kang
Pages: 57-72
Published online: 18 Jan 2013
AbstractforSample Size of Thorough QTc Clinical Trial Adjusted for Multiple Comparisons | Full Text | References | PDF (128.3 KB)
  • 263 Views
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Article
Bayesian Approach to Assay Sensitivity Analysis of Thorough QT Trials
Xiaoyu Dong, Xiao Ding & Yi Tsong
Pages: 73-81
Published online: 18 Jan 2013
AbstractforBayesian Approach to Assay Sensitivity Analysis of Thorough QT Trials | Full Text | References | PDF (94.6 KB)
  • 195 Views
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Article
Interdependence of Baseline Correction Method and Covariance Structure for Crossover TQT Studies
Wenqing Li, Andrea Maes, Michelle Quinlan & Suraj Anand
Pages: 82-97
Published online: 18 Jan 2013
AbstractforInterdependence of Baseline Correction Method and Covariance Structure for Crossover TQT Studies | Full Text | References | PDF (124.8 KB)
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Article
Comparing the Response Rates for Superiority, Noninferiority and Equivalence Testing with Multiple-to-One Matched Binary Data
Yi Tsong, Mengdie Yuan, Xiaoyu Dong, Yu-te Wu & Meiyu Shen
Pages: 98-109
Published online: 18 Jan 2013
AbstractforComparing the Response Rates for Superiority, Noninferiority and Equivalence Testing with Multiple-to-One Matched Binary Data | Full Text | References | PDF (114.1 KB)
  • 268 Views
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Article
Regulatory Issues of Propensity Score Methodology Application to Drug and Device Safety Studies
Mark S. Levenson & Lilly Q. Yue
Pages: 110-121
Published online: 18 Jan 2013
AbstractforRegulatory Issues of Propensity Score Methodology Application to Drug and Device Safety Studies | Full Text | References | PDF (121.4 KB)
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Article
Testing A Noninferiority Hypothesis: What to Anticipate when the Adverse Event is Rare
Bradley W. McEvoy & Eric Y. Frimpong
Pages: 122-128
Published online: 18 Jan 2013
AbstractforTesting A Noninferiority Hypothesis: What to Anticipate when the Adverse Event is Rare | Full Text | References | PDF (86.5 KB)
  • 220 Views
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Article
Comparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time to Event Data
Monica M. Bennett, Brenda J. Crowe, Karen L. Price, James D. Stamey & John W. Seaman Jr.
Pages: 129-145
Published online: 18 Jan 2013
AbstractforComparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time to Event Data | Full Text | References | PDF (442.5 KB)
  • 611 Views
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Article
Data Mining for Signal Detection of Adverse Event Safety Data
Hung-Chia Chen, Yi Tsong & James J. Chen
Pages: 146-160
Published online: 18 Jan 2013
AbstractforData Mining for Signal Detection of Adverse Event Safety Data | Full Text | References | PDF (151.6 KB)
  • 445 Views
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Article
Automated Method for Detecting Increases in Frequency of Spontaneous Adverse Event Reports over Time
William DuMouchel, Nancy Yuen, Nassrin Payvandi, Wendy Booth, Andrew Rut & David Fram
Pages: 161-177
Published online: 18 Jan 2013
AbstractforAutomated Method for Detecting Increases in Frequency of Spontaneous Adverse Event Reports over Time | Full Text | References | PDF (532.6 KB)
  • 357 Views
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Article
Likelihood Ratio Test-Based Method for Signal Detection in Drug Classes Using FDA's AERS Database
Lan Huang, Jyoti Zalkikar & Ram C. Tiwari
Pages: 178-200
Published online: 18 Jan 2013
AbstractforLikelihood Ratio Test-Based Method for Signal Detection in Drug Classes Using FDA's AERS Database | Full Text | References | PDF (245.8 KB)
  • 575 Views
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Article
Medical Records-Based Postmarketing Safety Evaluation of Rare Events with Uncertain Status
Hongyuan Cao, Lisa M. LaVange, Joseph F. Heyse, T. Christopher Mast & Michael R. Kosorok
Pages: 201-212
Published online: 18 Jan 2013
AbstractforMedical Records-Based Postmarketing Safety Evaluation of Rare Events with Uncertain Status | Full Text | References | PDF (432.6 KB)
  • 136 Views
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Article
A Bayesian Group Sequential Approach to Safety Signal Detection
Wenfeng Chen, Naiqing Zhao, Guoyou Qin & Jie Chen
Pages: 213-230
Published online: 18 Jan 2013
AbstractforA Bayesian Group Sequential Approach to Safety Signal Detection | Full Text | References | PDF (377.4 KB)
  • 437 Views
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Article
Quantitative Benefit-Risk Analysis for Evaluating Drug Therapies
Ralph L. Kodell & James J. Chen
Pages: 231-238
Published online: 18 Jan 2013
AbstractforQuantitative Benefit-Risk Analysis for Evaluating Drug Therapies | Full Text | References | PDF (171.9 KB)
  • 206 Views
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Article
Considerations for Design and Data Analysis of Noninferiority/Superiority Cardiovascular Trials
Hui Quan, Mingyu Li, Peng-Liang Zhao, Meehyung Cho, Ji Zhang & Yujun Wu
Pages: 239-260
Published online: 18 Jan 2013
AbstractforConsiderations for Design and Data Analysis of Noninferiority/Superiority Cardiovascular Trials | Full Text | References | PDF (170.5 KB)
  • 204 Views
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Article
Combining Risk Difference and Risk Ratio in Noninferiority Trials of Safety
Kristine R. Broglio, Jason T. Connor & Scott M. Berry
Pages: 261-271
Published online: 18 Jan 2013
AbstractforCombining Risk Difference and Risk Ratio in Noninferiority Trials of Safety | Full Text | References | PDF (271.1 KB)
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Book Reviews

Book Review
The Essentials of Biostatistics for Physicians, Nurses, and Clinicians, by M. R. Chernick
Hoboken, NJ: Wiley, 2011, ISBN 978-0-470-64185-9, x + 214 pp., $74.95.
Steve Simon
Pages: 272-274
Published online: 18 Jan 2013
First Page PreviewforThe Essentials of Biostatistics for Physicians, Nurses, and Clinicians, by M. R. Chernick | Full Text | References | PDF (54 KB)
  • 79 Views
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Book Review
Principles of Applied Statistics, by D. R. Cox and C. A. Donnelly
New York, NY: Cambridge University Press, 2011, ISBN 978-1-107-64445-8, x + 202 pp., $39.99.
Robert W. Hayden
Pages: 275-276
Published online: 18 Jan 2013
CitationforPrinciples of Applied Statistics, by D. R. Cox and C. A. Donnelly | Full Text | PDF (47.6 KB)
  • 130 Views
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Book Review
Measurement in Medicine, by H. C. W. de Vet, C. B. Terwee, L. B. Mokkink, and D. L. Knol
New York, NY: Cambridge University Press, 2011, ISBN 978-0-521-13385-2, x + 338 pp., $45.
Valentin Rousson
Pages: 277-279
Published online: 18 Jan 2013
First Page PreviewforMeasurement in Medicine, by H. C. W. de Vet, C. B. Terwee, L. B. Mokkink, and D. L. Knol | Full Text | References | PDF (52.5 KB)
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