Journal of Biopharmaceutical Statistics, Volume 20, Issue 1 (2009)

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Journal of Biopharmaceutical Statistics, Volume 20, Issue 1 (2009)

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Follow-on Biologics

Miscellany

Guest Editors' Note
Jen-Pei LiuEric Chi
Pages: 1-2
Published online: 12 Jan 2010
CitationforGuest Editors' Note | Full Text | PDF (27.4 KB)
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Original Articles

Article
Biosimilar Medicines—New Challenges for a New Class of Medicine
Andrew Fox
Pages: 3-9
Published online: 12 Jan 2010
AbstractforBiosimilar Medicines—New Challenges for a New Class of Medicine | Full Text | References | PDF (119.9 KB)
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Article
Statistical Assessment of Biosimilar Products
Shein-Chung Chow & Jen-pei Liu
Pages: 10-30
Published online: 12 Jan 2010
AbstractforStatistical Assessment of Biosimilar Products | Full Text | References | PDF (196.9 KB)
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Article
A Comparison of Moment-Based and Probability-Based Criteria for Assessment of Follow-On Biologics
Shein-Chung Chow, Tsung-Cheng Hsieh, Eric Chi & Jun Yang
Pages: 31-45
Published online: 12 Jan 2010
AbstractforA Comparison of Moment-Based and Probability-Based Criteria for Assessment of Follow-On Biologics | Full Text | References | PDF (587.4 KB)
  • 267 Views
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Article
Development of Biosimilars—Pharmacokinetic and Pharmacodynamic Considerations
Yow-Ming C. Wang & Andrew T. Chow
Pages: 46-61
Published online: 12 Jan 2010
AbstractforDevelopment of Biosimilars—Pharmacokinetic and Pharmacodynamic Considerations | Full Text | References | PDF (94.4 KB)
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Article
Evaluating Statistical Methods to Establish Clinical Similarity of Two Biologics
Lei Lei & Kurt Olson
Pages: 62-74
Published online: 12 Jan 2010
AbstractforEvaluating Statistical Methods to Establish Clinical Similarity of Two Biologics | Full Text | References | PDF (154.1 KB)
  • 214 Views
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Article
Statistical Test for Evaluation of Biosimilarity in Variability of Follow-On Biologics
Tsung-Cheng Hsieh, Shein-Chung Chow, Jen-pei Liu, Chin-Fu Hsiao & Eric Chi
Pages: 75-89
Published online: 12 Jan 2010
AbstractforStatistical Test for Evaluation of Biosimilarity in Variability of Follow-On Biologics | Full Text | References | PDF (134.4 KB)
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Article
Statistical Methods for Assessment of Biosimilarity Using Biomarker Data
Shein-Chung Chow, Qingshu Lu, Siu-Keung Tse & Eric Chi
Pages: 90-105
Published online: 12 Jan 2010
AbstractforStatistical Methods for Assessment of Biosimilarity Using Biomarker Data | Full Text | References | PDF (127.5 KB)
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ARTICLES

Article
Optimal Designs for Two-Arm, Phase II Clinical Trial Design with Multiple Constraints
Matthew S. Mayo, Jonathan D. Mahnken & Seng-jaw Soong
Pages: 106-124
Published online: 12 Jan 2010
AbstractforOptimal Designs for Two-Arm, Phase II Clinical Trial Design with Multiple Constraints | Full Text | References | PDF (296 KB)
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Article
Adaptive Bayesian Design for Phase I Dose-Finding Trials Using a Joint Model of Response and Toxicity
Meihua Wang & Roger Day
Pages: 125-144
Published online: 12 Jan 2010
AbstractforAdaptive Bayesian Design for Phase I Dose-Finding Trials Using a Joint Model of Response and Toxicity | Full Text | References | PDF (805.3 KB)
  • 203 Views
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Article
On Group Sequential Designs Comparing Two Binomial Proportions
James L. Kepner
Pages: 145-159
Published online: 12 Jan 2010
AbstractforOn Group Sequential Designs Comparing Two Binomial Proportions | Full Text | References | PDF (103.2 KB)
  • 234 Views
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Article
Classification of High-Dimensional Data with Ensemble of Logistic Regression Models
Noha Lim, Hongshik Ahn, Hojin Moon & James J. Chen
Pages: 160-171
Published online: 12 Jan 2010
AbstractforClassification of High-Dimensional Data with Ensemble of Logistic Regression Models | Full Text | References | PDF (211.1 KB)
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Article
Tolerance Limits for a Ratio of Normal Random Variables
Lanju Zhang, Thomas Mathew, Harry Yang, K. Krishnamoorthy & Iksung Cho
Pages: 172-184
Published online: 12 Jan 2010
AbstractforTolerance Limits for a Ratio of Normal Random Variables | Full Text | References | PDF (109.9 KB)
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BOOK REVIEWS

Book Review
A Review of: “Making Data Talk: Communicating Public Health Data to the Public, Policy Makers, and the Press, by D. E. Nelson, B. W. Hesse, and R. T. Croyle”
New York: Oxford University Press, 2009, ISBN 978-0-19-538153-5, xvii + 321 pp., $39.95.
Robert W. Hayden
Pages: 185-186
Published online: 12 Jan 2010
CitationforA Review of: “Making Data Talk: Communicating Public Health Data to the Public, Policy Makers, and the Press, by D. E. Nelson, B. W. Hesse, and R. T. Croyle” | Full Text | PDF (33.4 KB)
  • 35 Views
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Book Review
A Review of: “Cluster Randomised Trials, by R. J. Hayes and L. H. Moulton”
Boca Raton, FL: Chapman & Hall/CRC, 2009, ISBN 978-1-58488-816-1, xxii + 315 pp., $89.95.
Neil Klar
Pages: 187-189
Published online: 12 Jan 2010
First Page PreviewforA Review of: “Cluster Randomised Trials, by R. J. Hayes and L. H. Moulton” | Full Text | References | PDF (35 KB)
  • 163 Views
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Book Review
A Review of: “Common Errors in Statistics (and How to Avoid Them), Third Edition, by P. I. Good and J. W. Hardin”
New York: Wiley, 2009, ISBN 978-0-470-45798-6, xiii + 273 pp., $59.95.
Robert W. Hayden
Page: 190
Published online: 12 Jan 2010
CitationforA Review of: “Common Errors in Statistics (and How to Avoid Them), Third Edition, by P. I. Good and J. W. Hardin” | Full Text | References | PDF (29 KB)
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