Journal of Biopharmaceutical Statistics, Volume 24, Issue 6 (2014)

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Journal of Biopharmaceutical Statistics, Volume 24, Issue 6 (2014)

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Issues in Biosimilar Drug Development

Original Articles

Article
Preface
Bin Yao & Eric Chi
Page: 1137
Published online: 31 Oct 2014
CitationforPreface | Full Text | PDF (57.5 KB)
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Article
Scientific Factors and Current Issues in Biosimilar Studies
Shein-Chung Chow, Laszlo Endrenyi, Peter A. Lachenbruch & France Mentré
Pages: 1138-1153
Published online: 31 Oct 2014
AbstractforScientific Factors and Current Issues in Biosimilar Studies | Full Text | References | PDF (145.2 KB)
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Article
Biosimilars: Where We Were and Where We Are
Rodeina Challand, Hazel Gorham & John Constant
Pages: 1154-1164
Published online: 31 Oct 2014
AbstractforBiosimilars: Where We Were and Where We Are | Full Text | References | PDF (115.6 KB)
  • 418 Views
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Article
Clinical Development and Trial Design of Biosimilar Products: A Japanese Perspective
Masayuki Nagasaki & Yuki Ando
Pages: 1165-1172
Published online: 31 Oct 2014
AbstractforClinical Development and Trial Design of Biosimilar Products: A Japanese Perspective | Full Text | References | PDF (97.4 KB)
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Article
Covariate Effect on Constancy Assumption in Noninferiority Clinical Trials
Siyan Xu, Kerry Barker, Sandeep Menon & Ralph B. D’Agostino
Pages: 1173-1189
Published online: 31 Oct 2014
AbstractforCovariate Effect on Constancy Assumption in Noninferiority Clinical Trials | Full Text | References | PDF (442.5 KB)
  • 265 Views
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Article
Sample Size Determination for a Three-Arm Equivalence Trial of Normally Distributed Responses
Yu-Wei Chang, Yi Tsong, Xiaoyu Dong & Zhigen Zhao
Pages: 1190-1202
Published online: 31 Oct 2014
AbstractforSample Size Determination for a Three-Arm Equivalence Trial of Normally Distributed Responses | Full Text | References | PDF (171.2 KB)
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Article
Sample Size Determination for Equivalence Assessment with Multiple Endpoints
Anna Sun, Xiaoyu Dong & Yi Tsong
Pages: 1203-1214
Published online: 31 Oct 2014
AbstractforSample Size Determination for Equivalence Assessment with Multiple Endpoints | Full Text | References | PDF (216.1 KB)
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Article
Sample Size Calculations for the Development of Biosimilar Products
Seung-Ho Kang & Yongjo Kim
Pages: 1215-1224
Published online: 31 Oct 2014
AbstractforSample Size Calculations for the Development of Biosimilar Products | Full Text | References | PDF (161.2 KB)
  • 414 Views
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Article
On the Lower Predictive Bound Approach for Noninferiority Clinical Trials with Binary Data
Qing Liu & Yulan Li
Pages: 1225-1238
Published online: 31 Oct 2014
AbstractforOn the Lower Predictive Bound Approach for Noninferiority Clinical Trials with Binary Data | Full Text | References | PDF (142.3 KB)
  • 204 Views
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Article
Nonparametric Tests for Evaluation of Biosimilarity in Variability of Follow-on Biologics
Nan Zhang, Jun Yang, Shein-Chung Chow & Eric Chi
Pages: 1239-1253
Published online: 31 Oct 2014
AbstractforNonparametric Tests for Evaluation of Biosimilarity in Variability of Follow-on Biologics | Full Text | References | PDF (408.6 KB)
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Article
Applications of the Bayesian Prior Information to Evaluation of Equivalence of Similar Biological Medicinal Products
Shih-Ting Chiu, Jen-Pei Liu & Shein-Chung Chow
Pages: 1254-1263
Published online: 31 Oct 2014
AbstractforApplications of the Bayesian Prior Information to Evaluation of Equivalence of Similar Biological Medicinal Products | Full Text | References | PDF (115.6 KB)
  • 251 Views
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Article
Inference of Equivalence for the Ratio of Two Normal Means with Unspecified Variances
Siyan Xu, Steven Ye Hua, Ronald Menton, Kerry Barker, Sandeep Menon & Ralph B. D’Agostino
Pages: 1264-1279
Published online: 31 Oct 2014
AbstractforInference of Equivalence for the Ratio of Two Normal Means with Unspecified Variances | Full Text | References | PDF (509.6 KB)
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Article
Frequency Estimator for Assessing of Follow-On Biologics
Ying Lu, Zhong-Zhan Zhang & Shein-Chung Chow
Pages: 1280-1297
Published online: 31 Oct 2014
AbstractforFrequency Estimator for Assessing of Follow-On Biologics | Full Text | References | PDF (227.7 KB)
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Article
Estimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability
Lan-Yan Yang & Chyong-Huey Lai
Pages: 1298-1311
Published online: 31 Oct 2014
AbstractforEstimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability | Full Text | References | PDF (273.9 KB)
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Article
Equivalence Assessment for Interchangeability Based on Two-Sided Tests
Xiaoyu Dong & Yi Tsong
Pages: 1312-1331
Published online: 31 Oct 2014
AbstractforEquivalence Assessment for Interchangeability Based on Two-Sided Tests | Full Text | References | PDF (248.9 KB)
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Article
Equivalence Tests for Interchangeability Based on Two One-Sided Probabilities
Xiaoyu Dong, Yi Tsong & Meiyu Shen
Pages: 1332-1348
Published online: 31 Oct 2014
AbstractforEquivalence Tests for Interchangeability Based on Two One-Sided Probabilities | Full Text | References | PDF (245.9 KB)
  • 341 Views
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Book Reviews

Book Review
Book Review: Applied Meta-Analysis With R, by Ding-Geng Chen and Karl E. Peace
Boca Raton, FL: Chapman and Hall/CRC, 2013, ISBN 9781466505995, 341 pp., $89.95.
Stephanie A. Kovalchik
Pages: 1349-1351
Published online: 02 Sep 2014
First Page PreviewforBook Review: Applied Meta-Analysis With R, by Ding-Geng Chen and Karl E. Peace | Full Text | References | PDF (71.1 KB)
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Book Review
Book Review: Design and Analysis of Clinical Trials: Concepts and Methodologies, 3rd edition, by Shein-Chung Chow and Jen-Pei Liu
Hoboken, NJ: Wiley Series in Probability and Statistics, 2013, ISBN 9780470887653, 892 pp., $149.95.
Euloge Kpamegan
Pages: 1352-1354
Published online: 12 Sep 2014
First Page PreviewforBook Review: Design and Analysis of Clinical Trials: Concepts and Methodologies, 3rd edition, by Shein-Chung Chow and Jen-Pei Liu | Full Text | References | PDF (68.4 KB)
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Book Review
Book Review: Patient-Reported Outcomes—Measurement, Implementation and Interpretation, by Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Demissie Alemayehu, and Tara Symonds
Boca Raton, FL: Chapman and Hall/CRC, 2013, ISBN 9781439873670, 351 pp., $99.95.
Zhenqiu Lin
Pages: 1355-1357
Published online: 02 Sep 2014
First Page PreviewforBook Review: Patient-Reported Outcomes—Measurement, Implementation and Interpretation, by Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Demissie Alemayehu, and Tara Symonds | Full Text | References | PDF (64.9 KB)
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Short Communication

Comment on “Analysis of Longitudinal Trials With Protocol Deviations: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation,” by Carpenter, Roger, and Kenward
Shaun R. Seaman, Ian R. White & Finbarr P. Leacy
Pages: 1358-1362
Published online: 31 Oct 2014
First Page PreviewforComment on “Analysis of Longitudinal Trials With Protocol Deviations: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation,” by Carpenter, Roger, and Kenward | Full Text | References | PDF (95 KB)
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Open Access

Letter

Letter
Response to Comments by Seaman et al. on “Analysis of Longitudinal Trials With Protocol Deviation: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation,” Journal of Biopharmaceutical Statistics 23:1352–1371
J. R. Carpenter, J. H. Roger, S. Cro & M. G. Kenward
Pages: 1363-1369
Published online: 12 Sep 2014
First Page PreviewforResponse to Comments by Seaman et al. on “Analysis of Longitudinal Trials With Protocol Deviation: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation,” Journal of Biopharmaceutical Statistics 23:1352–1371 | Full Text | References | PDF (126.7 KB)
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Editorial Board

EOV Editorial Board
Page: ebi
Published online: 31 Oct 2014
CitationforEOV Editorial Board | Full Text | PDF (27.6 KB)
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