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Journal of Biopharmaceutical Statistics, Volume 18 Issue 1 2008

Now Listed with IF of 0.951 ©2009 Thomson Reuters, 2008 Journal Citiation Reports®
ISSN: 1520-5711 (electronic) 1054-3406 (paper)
Publication Frequency: 6 issues per year
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Original Articles
Special Issue on Medical Device Clinical Studies – Guest Editor's Note
Lilly Q. Yue
Pages 1 – 3
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Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals
Gregory Campbell
Pages 4 – 19
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Statistical and Regulatory Issues in Nonrandomized Medical Device Clinical Studies
Heng Li; Lilly Q. Yue
Pages 20 – 30
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Design Effects for Highly Clustered Count Data with Varying Length of Follow-up – Applying to the Analysis of ICD Shocks
Zengri J. Wang
Pages 31 – 43
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Longitudinal Data Analysis in Medical Device Clinical Studies
Chang S. Lao; Harry F. Bushar
Pages 44 – 53
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Practical Bayesian Design and Analysis for Drug and Device Clinical Trials
Brian P. Hobbs; Bradley P. Carlin
Pages 54 – 80
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Experience with Reviewing Bayesian Medical Device Trials
Gene Pennello; Laura Thompson
Pages 81 – 115
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An Adaptive Approach to Designing Comparative Diagnostic Accuracy Studies
Chengqing Wu;  Aiyi Liu; Kai F. Yu
Pages 116 – 125
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Overview of Agreement Statistics for Medical Devices
Lawrence Lin
Pages 126 – 144
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Comparing Two Medical Tests When Results of Reference Standard Are Unavailable for Those Negative via Both Tests
Marina V. Kondratovich
Pages 145 – 166
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Statistical Issues on the Diagnostic Multivariate Index Assay for Targeted Clinical Trials
Jen-pei Liu; Shein-Chung Chow
Pages 167 – 182
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Challenges in DNA Microarray Studies from the Regulatory Perspective
Samir Lababidi
Pages 183 – 202
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Book Reviews
A Review of: “Adaptive Design Methods in Clinical Trials, by S.-C. Chow and Mark Chang”
Boca Raton: Chapman & Hall/CRC, 2007, ISBN 1-58488-776-1, 277 pp., $89.95.
Jeff Maca
Pages 203 – 205
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A Review of: “Presenting Medical Statistics from Proposal to Publication: A Step-by-Step Guide, by J. L. Peacock and S. M. Kerry”
New York: Oxford University Press, 2007, ISBN 0-19-859966-8, xii + 174 pp., $49.50.
Robert W. Hayden
Pages 206 – 207
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A Review of: “Bioequivalence Studies in Drug Development: Methods and Applications, by D. Hauschke, V. Steinijans and I. Pigeot”
New York: Wiley, 2007, ISBN 978-0-470-09475-4, xi + 311 pp., $100.
Scott Patterson
Pages 208 – 209
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