Journal of Biopharmaceutical Statistics, Volume 22, Issue 5 (2012)

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Journal of Biopharmaceutical Statistics, Volume 22, Issue 5 (2012)

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Bridging and Multiregional Clinical Trials

Editorials

Editorial
Guest Editors' Note for the Special Issue on the Statistical Considerations for the Design and Analysis of Bridging and Multiregional Clinical Trials
Yi Tsong & William Wang
Pages: 875-878
Published online: 04 Sep 2012
First Page PreviewforGuest Editors' Note for the Special Issue on the Statistical Considerations for the Design and Analysis of Bridging and Multiregional Clinical Trials | Full Text | References | PDF (62 KB)
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Original Articles

Article
Ethnic Sensitive or Molecular Sensitive Beyond All Regions Being Equal in Multiregional Clinical Trials
Sue-Jane Wang & H. M. James Hung
Pages: 879-893
Published online: 04 Sep 2012
AbstractforEthnic Sensitive or Molecular Sensitive Beyond All Regions Being Equal in Multiregional Clinical Trials | Full Text | References | PDF (231.3 KB)
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Article
Assessing Dose–Region Profile of Drug Efficacy: A Multiregional Trial Strategy
Yi-Hau Chen & Mey Wang
Pages: 894-902
Published online: 04 Sep 2012
AbstractforAssessing Dose–Region Profile of Drug Efficacy: A Multiregional Trial Strategy | Full Text | References | PDF (270.2 KB)
  • 205 Views
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Article
Statistical Methods for Bridging Studies
Shein-Chung Chow, Chieh Chiang, Jen-pei Liu & Chin-Fu Hsiao
Pages: 903-915
Published online: 04 Sep 2012
AbstractforStatistical Methods for Bridging Studies | Full Text | References | PDF (136.6 KB)
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Article
A Predictive Bayesian Approach to the Design and Analysis of Bridging Studies
A. Lawrence Gould, Tian Jin, Li Xin Zhang & William W. B. Wang
Pages: 916-934
Published online: 04 Sep 2012
AbstractforA Predictive Bayesian Approach to the Design and Analysis of Bridging Studies | Full Text | References | PDF (622 KB) | Supplemental
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Article
A Bayesian Approach for Inference from a Bridging Study with Binary Outcomes
Mihir Gandhi, Bhaswati Mukherjee & Debjit Biswas
Pages: 935-951
Published online: 04 Sep 2012
AbstractforA Bayesian Approach for Inference from a Bridging Study with Binary Outcomes | Full Text | References | PDF (844.6 KB)
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Article
Weighted Evidence Approach of Bridging Study
Hsiao-Hui Tsou, Yi Tsong, Jung-Tzu Liu, Xiaoyu Dong & Yute Wu
Pages: 952-965
Published online: 04 Sep 2012
AbstractforWeighted Evidence Approach of Bridging Study | Full Text | References | PDF (292.4 KB)
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Article
A Note on Two Approaches of Testing Bridging Evidence to a New Region
Xiaoyu Dong, Yu Guo & Yi Tsong
Pages: 966-976
Published online: 04 Sep 2012
AbstractforA Note on Two Approaches of Testing Bridging Evidence to a New Region | Full Text | References | PDF (108.1 KB)
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Article
Multiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects
Yuki Ando & Yoshiaki Uyama
Pages: 977-987
Published online: 04 Sep 2012
AbstractforMultiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects | Full Text | References | PDF (357.6 KB)
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Article
Qualitative Consistency of Treatment Effects in Multiregional Clinical Trials
Yoko Tanaka, Gang Li, Yining Wang & Josh Chen
Pages: 988-1000
Published online: 04 Sep 2012
AbstractforQualitative Consistency of Treatment Effects in Multiregional Clinical Trials | Full Text | References | PDF (425.3 KB)
  • 369 Views
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Article
Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials
Xiaoyuan Chen, Nelson Lu, Rajesh Nair, Yunling Xu, Cailian Kang, Qin Huang, Ning Li & Hongzhuan Chen
Pages: 1001-1018
Published online: 04 Sep 2012
AbstractforDecision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials | Full Text | References | PDF (167.7 KB)
  • 440 Views
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Article
Assessment of Regional Treatment Effect in a Multiregional Clinical Trial
Yi Tsong, Wan-Jung Chang, Xiaoyu Dong & Hsiao-Hui Tsou
Pages: 1019-1036
Published online: 04 Sep 2012
AbstractforAssessment of Regional Treatment Effect in a Multiregional Clinical Trial | Full Text | References | PDF (144.3 KB)
  • 493 Views
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Article
Design and Evaluation of Multiregional Trials with Heterogeneous Treatment Effect Across Regions
Chi-Tian Chen, H. M. James Hung & Chin-Fu Hsiao
Pages: 1037-1050
Published online: 04 Sep 2012
AbstractforDesign and Evaluation of Multiregional Trials with Heterogeneous Treatment Effect Across Regions | Full Text | References | PDF (118.1 KB)
  • 367 Views
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Article
Design and Analysis Issues of Multiregional Clinical Trials with Different Regional Primary Endpoints
Hsiao-Hui Tsou, Yi Tsong, Wan-Jung Chang, Xiaoyu Dong & Chin-Fu Hsiao
Pages: 1051-1059
Published online: 04 Sep 2012
AbstractforDesign and Analysis Issues of Multiregional Clinical Trials with Different Regional Primary Endpoints | Full Text | References | PDF (95.4 KB)
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Article
Design and Sample Size Considerations for Simultaneous Global Drug Development Program
Qin Huang, Gang Chen, Zhilong Yuan & K. K. Gordon Lan
Pages: 1060-1073
Published online: 04 Sep 2012
AbstractforDesign and Sample Size Considerations for Simultaneous Global Drug Development Program | Full Text | References | PDF (155.7 KB)
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Commentary

Article Commentary
Practical and Statistical Considerations on Simultaneous Global Drug Development
Ning Li & William Wang
Pages: 1074-1077
Published online: 04 Sep 2012
First Page PreviewforPractical and Statistical Considerations on Simultaneous Global Drug Development | Full Text | References | PDF (64.9 KB)
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Article Commentary
Statistical Considerations on Design and Analysis of Bridging and Multiregional Clinical Trials
Yi Tsong
Pages: 1078-1080
Published online: 04 Sep 2012
First Page PreviewforStatistical Considerations on Design and Analysis of Bridging and Multiregional Clinical Trials | Full Text | References | PDF (58.6 KB)
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Book Reviews

Book Review
A Review of: “Econometric Analysis, Seventh Edition, by W. H. Greene”
Upper Saddle River, NJ: Prentice Hall, 2012, ISBN 978-0-13-139538-1, xxxix + 1188 pp., $200.
Jeffrey S. Hoch
Pages: 1081-1083
Published online: 04 Sep 2012
First Page PreviewforA Review of: “Econometric Analysis, Seventh Edition, by W. H. Greene” | Full Text | PDF (51.4 KB)
  • 562 Views
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Book Review
A Review of: “Design and Analysis of Non-Inferiority Trials, by M. D. Rothmann, B. L. Wiens, and I. S. F. Chan”
Boca Raton, FL: Chapman & Hall/CRC, 2012, ISBN 978-1-58488-804-8, xvi + 438 pp., $89.95.
Steffen Witte
Pages: 1084-1087
Published online: 04 Sep 2012
First Page PreviewforA Review of: “Design and Analysis of Non-Inferiority Trials, by M. D. Rothmann, B. L. Wiens, and I. S. F. Chan” | Full Text | References | PDF (55 KB)
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BOOK REVIEW

Book Review
A Review of: “Controversial Statistical Issues in Clinical Trials, by S.-C. Chow”
Boca Raton, FL: Chapman & Hall/CRC, 2011, ISBN 978-1-4398-4961-3, xix + 590 pp., $99.95.
William Mietlowski
Pages: 1088-1096
Published online: 04 Sep 2012
First Page PreviewforA Review of: “Controversial Statistical Issues in Clinical Trials, by S.-C. Chow” | Full Text | References | PDF (75.4 KB)
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