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Volume 24, Issue 5

Journal of Biopharmaceutical Statistics

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Journal of Biopharmaceutical Statistics, Volume 24, Issue 5 (2014)

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Journal of Biopharmaceutical Statistics, Volume 24, Issue 5 (2014)

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Vol 34, 2024 Vol 33, 2023 Vol 32, 2022 Vol 31, 2021 Vol 30, 2020 Vol 29, 2019 Vol 28, 2018 Vol 27, 2017 Vol 26, 2016 Vol 25, 2015 Volume 24, 2014 Vol 23, 2013 Vol 22, 2012 Vol 21, 2010-2011 Vol 20, 2009-2010 Vol 19, 2009 Vol 18, 2007-2008 Vol 17, 2007 Vol 16, 2006 Vol 15, 2005 Vol 14, 2004 Vol 13, 2003 Vol 12, 2002 Vol 11, 2001 Vol 10, 2000 Vol 9, 1999 Vol 8, 1998 Vol 7, 1997 Vol 6, 1996 Vol 5, 1995 Vol 4, 1994 Vol 3, 1993 Vol 2, 1992 Vol 1, 1991

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The 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop

Guest Editorial

Guest Editors’ Note: Special Issue Associated With the 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop

Bruce Binkowitz & Lilly Q. Yue

Pages: 965-967

Published online: 11 Aug 2014

First Page PreviewforGuest Editors’ Note: Special Issue Associated With the 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop | Full Text | PDF (71.4 KB)

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Original Articles

Article

Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials

Thomas R. Fleming, Charles H. Hennekens, Marc A. Pfeffer & David L. DeMets

Pages: 968-975

Published online: 11 Aug 2014

AbstractforEnhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials | Full Text | References | PDF (98.1 KB)

305 Views
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Article

Alternative Views On Setting Clinical Trial Futility Criteria

Paul Gallo, Lu Mao & Vivian H. Shih

Pages: 976-993

Published online: 11 Aug 2014

AbstractforAlternative Views On Setting Clinical Trial Futility Criteria | Full Text | References | PDF (238 KB)

1358 Views
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Article

Designing Premarket Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities

Lilly Q. Yue, Nelson Lu & Yunling Xu

Pages: 994-1010

Published online: 11 Aug 2014

AbstractforDesigning Premarket Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities | Full Text | References | PDF (308.9 KB)

721 Views
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Article

Stratification and Partial Ascertainment of Biomarker Value in Biomarker-Driven Clinical Trials

Richard Simon

Pages: 1011-1021

Published online: 11 Aug 2014

AbstractforStratification and Partial Ascertainment of Biomarker Value in Biomarker-Driven Clinical Trials | Full Text | References | PDF (113.3 KB)

254 Views
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Article

Separate Class True Discovery Rate Degree of Association Sets for Biomarker Identification

Michael R. Crager & Murat Ahmed

Pages: 1022-1034

Published online: 11 Aug 2014

AbstractforSeparate Class True Discovery Rate Degree of Association Sets for Biomarker Identification | Full Text | References | PDF (417.5 KB)

79 Views
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Article

Adaptive Sequential Testing for Multiple Comparisons

Ping Gao, Lingyun Liu & Cyrus Mehta

Pages: 1035-1058

Published online: 11 Aug 2014

AbstractforAdaptive Sequential Testing for Multiple Comparisons | Full Text | References | PDF (236.9 KB)

325 Views
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Article

Some Challenges With Statistical Inference in Adaptive Designs

H. M. James Hung, Sue-Jane Wang & Peiling Yang

Pages: 1059-1072

Published online: 11 Aug 2014

AbstractforSome Challenges With Statistical Inference in Adaptive Designs | Full Text | References | PDF (147.2 KB)

596 Views
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Article

A Case Study of Modeling and Exposure-Response Prediction for Count Data

Hui Quan, Xuezhou Mao, Lynn Wei & Lin Wang

Pages: 1073-1090

Published online: 11 Aug 2014

AbstractforA Case Study of Modeling and Exposure-Response Prediction for Count Data | Full Text | References | PDF (369.2 KB)

154 Views
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Article

Dose Finding With the Sequential Parallel Comparison Design

Jessie J. Wang & Anastasia Ivanova

Pages: 1091-1101

Published online: 11 Aug 2014

AbstractforDose Finding With the Sequential Parallel Comparison Design | Full Text | References | PDF (166.3 KB)

329 Views
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Article

A Note on Breast Cancer Trials With pCR-Based Accelerated Approval

Yi Xia, Lu Cui & Bo Yang

Pages: 1102-1114

Published online: 11 Aug 2014

AbstractforA Note on Breast Cancer Trials With pCR-Based Accelerated Approval | Full Text | References | PDF (184.4 KB)

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Article

Truncated Outlier Filtering

Peter J. Costa

Pages: 1115-1129

Published online: 11 Aug 2014

AbstractforTruncated Outlier Filtering | Full Text | References | PDF (486.5 KB)

276 Views
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Book Reviews

Book Review

Book Review: Analysis of Mixed Data: Methods & Application, by Alexander R. de Leon and Keumhee Carrière Chough

Boca Raton, FL: Chapman and Hall/CRC, 2013, ISBN 978-1-4398-8471-3, xxvii + 234 pp., $89.95.

Zhigang Li

Pages: 1130-1131

Published online: 11 Aug 2014

CitationforBook Review: Analysis of Mixed Data: Methods & Application, by Alexander R. de Leon and Keumhee Carrière Chough | Full Text | References | PDF (65.3 KB)

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Book Review

Book Review: Biosimilars—Design and Analysis of Follow-On Biologics, by Shein-Chung Chow

Boca Raton, FL: Chapman and Hall/CRC, 2012, ISBN 9781466579699, 444 pp., $89.95.

Yi Tsong

Pages: 1132-1135

Published online: 11 Aug 2014

First Page PreviewforBook Review: Biosimilars—Design and Analysis of Follow-On Biologics, by Shein-Chung Chow | Full Text | PDF (75 KB)

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Corrigendum

Correction

Corrigendum

Page: 1136

Published online: 11 Aug 2014

CitationforCorrigendum | Full Text | PDF (58 KB)

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Journal of Biopharmaceutical Statistics (Vol.24, Iss.5, 2014)

The 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop

The 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop

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