Journal of Biopharmaceutical Statistics, Volume 23, Issue 4 (2013)

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Journal of Biopharmaceutical Statistics, Volume 23, Issue 4 (2013)

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Original Articles

Article
Pure and Hybrid Causal Effects on Variables Associated with an Incident Event
Qi Jiang & Steven Snapinn
Pages: 719-729
Published online: 20 Jun 2013
AbstractforPure and Hybrid Causal Effects on Variables Associated with an Incident Event | Full Text | References | PDF (97 KB)
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Article
Establishment of an Equivalence Acceptance Criterion for Accelerated Stability Studies
Richard K. Burdick & Leslie Sidor
Pages: 730-743
Published online: 25 Jun 2013
AbstractforEstablishment of an Equivalence Acceptance Criterion for Accelerated Stability Studies | Full Text | References | PDF (770.9 KB)
  • 660 Views
  • 12 CrossRef citations
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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: 744-755
Published online: 20 Jun 2013
AbstractforMedical Records-Based Postmarketing Safety Evaluation of Rare Events with Uncertain Status | Full Text | References | PDF (445.7 KB)
  • 107 Views
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Article
Five Interval Estimators of the Risk Difference Under Stratified Randomized Clinical Trials with Noncompliance and Repeated Measurements
Kung-Jong Lui & Kuang-Chao Chang
Pages: 756-773
Published online: 20 Jun 2013
AbstractforFive Interval Estimators of the Risk Difference Under Stratified Randomized Clinical Trials with Noncompliance and Repeated Measurements | Full Text | References | PDF (146.2 KB)
  • 113 Views
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Article
Three-Arm Noninferiority Trials with a Prespecified Margin for Inference of the Difference in the Proportions of Binary Endpoints
Eisuke Hida & Toshiro Tango
Pages: 774-789
Published online: 25 Jun 2013
AbstractforThree-Arm Noninferiority Trials with a Prespecified Margin for Inference of the Difference in the Proportions of Binary Endpoints | Full Text | References | PDF (153.6 KB)
  • 291 Views
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Article
Bayesian Sample Size Determination for a Clinical Trial with Correlated Continuous and Binary Outcomes
James D. Stamey, Fanni Natanegara & John W. Seaman Jr.
Pages: 790-803
Published online: 20 Jun 2013
AbstractforBayesian Sample Size Determination for a Clinical Trial with Correlated Continuous and Binary Outcomes | Full Text | References | PDF (474.6 KB)
  • 365 Views
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Article
Crossover Versus Parallel Designs: Dose-Escalation Design Comparisons for First-In-Human Studies
Zhiwu Yan, Balakrishna Hosmane & Charles Locke
Pages: 804-817
Published online: 20 Jun 2013
AbstractforCrossover Versus Parallel Designs: Dose-Escalation Design Comparisons for First-In-Human Studies | Full Text | References | PDF (127.1 KB)
  • 353 Views
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Article
Optimal Allocation of Sample Sizes to Multicenter Clinical Trials
Dejian Lai, Kuang-Chao Chang, Mohammad H. Rahbar & Lemuel A. Moye
Pages: 818-828
Published online: 20 Jun 2013
AbstractforOptimal Allocation of Sample Sizes to Multicenter Clinical Trials | Full Text | References | PDF (422.9 KB)
  • 219 Views
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Article
Detecting Potential Safety Issues in Large Clinical or Observational Trials by Bayesian Screening When Event Counts Arise from Poisson Distributions
A. Lawrence Gould
Pages: 829-847
Published online: 20 Jun 2013
AbstractforDetecting Potential Safety Issues in Large Clinical or Observational Trials by Bayesian Screening When Event Counts Arise from Poisson Distributions | Full Text | References | PDF (191.7 KB) | Supplemental
  • 243 Views
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Article
Estimation of the Common Risk Difference in Stratified Paired Binary Data with Homogeneous Stratum Effect
Yan D. Zhao & Dewi Rahardja
Pages: 848-855
Published online: 20 Jun 2013
AbstractforEstimation of the Common Risk Difference in Stratified Paired Binary Data with Homogeneous Stratum Effect | Full Text | References | PDF (258 KB)
  • 157 Views
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Article
Fractional Dose-Finding Methods with Late-Onset Toxicity in Phase I Clinical Trials
Guosheng Yin, Shurong Zheng & Jiajing Xu
Pages: 856-870
Published online: 20 Jun 2013
AbstractforFractional Dose-Finding Methods with Late-Onset Toxicity in Phase I Clinical Trials | Full Text | References | PDF (153.6 KB)
  • 262 Views
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Article
The Joint Modeling of Drug and Positive Control Effects to Estimate Sample Size and Power in Crossover “Thorough” QT/QTc Studies
Balakrishna Hosmane, Charles Locke & Yi-Lin Chiu
Pages: 871-880
Published online: 20 Jun 2013
AbstractforThe Joint Modeling of Drug and Positive Control Effects to Estimate Sample Size and Power in Crossover “Thorough” QT/QTc Studies | Full Text | References | PDF (103.2 KB)
  • 159 Views
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Article
Evaluating the Performance of the ICH Guidelines for Shelf Life Estimation
Michelle Quinlan, Walter Stroup, James Schwenke & David Christopher
Pages: 881-896
Published online: 20 Jun 2013
AbstractforEvaluating the Performance of the ICH Guidelines for Shelf Life Estimation | Full Text | References | PDF (1.2 MB)
  • 492 Views
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Article
On the Distribution of Batch Shelf Lives
Michelle Quinlan, Walter Stroup, David Christopher & James Schwenke
Pages: 897-920
Published online: 20 Jun 2013
AbstractforOn the Distribution of Batch Shelf Lives | Full Text | References | PDF (1.4 MB)
  • 300 Views
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Article
Statistical Estimation & Inference of Cell Counts from ELISPOT Limiting Dilution Assays
Hongmei Yang, David J. Topham, Jeanne Holden-Wiltse & Hulin Wu
Pages: 921-936
Published online: 20 Jun 2013
AbstractforStatistical Estimation & Inference of Cell Counts from ELISPOT Limiting Dilution Assays | Full Text | References | PDF (1.4 MB)
  • 119 Views
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Letter to the Editor

Letter
Further Insights in Sample Size Calculation
Bruno Mario Cesana
Pages: 937-939
Published online: 20 Jun 2013
First Page PreviewforFurther Insights in Sample Size Calculation | Full Text | References | PDF (57.3 KB)
  • 171 Views
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Book Reviews

Book Review
Applied Longitudinal Analysis, 2nd Edition, by Garrett M. Fitzmaurice, Nan M. Laird, and James H. Ware, John Wiley & Sons, 2011
ISBN 978-0-470-38027-7, 740 pp., $125.
Amy H. Herring
Pages: 940-941
Published online: 25 Jun 2013
CitationforApplied Longitudinal Analysis, 2nd Edition, by Garrett M. Fitzmaurice, Nan M. Laird, and James H. Ware, John Wiley & Sons, 2011 | Full Text | References | PDF (51.4 KB)
  • 916 Views
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Book Review
Design and Analysis of Experiments in the Health Sciences, First Edition, by Gerald Van Belle and Kathleen F. Kerr, John Wiley & Sons, 2012
ISBN 978-0-470-12727-8, xv +229 pp., $59.95
Pallavi Chitturi
Pages: 942-943
Published online: 25 Jun 2013
CitationforDesign and Analysis of Experiments in the Health Sciences, First Edition, by Gerald Van Belle and Kathleen F. Kerr, John Wiley & Sons, 2012 | Full Text | References | PDF (54.3 KB)
  • 84 Views
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Book Review
Bayesian Biostatistics, by Emmanuel Lesaffre and Andrew B. Lawson, John Wiley & Sons, 2012
ISBN 978-0-470-01823-1, x +516 pp., $75.
Mani Lakshminarayanan
Pages: 944-947
Published online: 25 Jun 2013
First Page PreviewforBayesian Biostatistics, by Emmanuel Lesaffre and Andrew B. Lawson, John Wiley & Sons, 2012 | Full Text | References | PDF (56.9 KB)
  • 272 Views
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