Journal of Biopharmaceutical Statistics, Volume 21, Issue 4 (2011)

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Journal of Biopharmaceutical Statistics, Volume 21, Issue 4 (2011)

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Dealing with Multiplicity in Drug Development: Current State and New Directions

Miscellany

Special Issue for Dealing with Multiplicity in Drug Development: Current State and New Directions – Guest Editors' Note
Alex Dmitrienko & Martin Posch
Pages: 581-582
Published online: 22 Apr 2011
CitationforSpecial Issue for Dealing with Multiplicity in Drug Development: Current State and New Directions – Guest Editors' Note | Full Text | PDF (52.3 KB)
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Original Articles

Article
How Well Do Multiple Testing Methods Scale Up when Both n and k Increase?
Peter H. Westfall & Ananda Manage
Pages: 583-594
Published online: 22 Apr 2011
AbstractforHow Well Do Multiple Testing Methods Scale Up when Both n and k Increase? | Full Text | References | PDF (210 KB)
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Article
Multiple Hypotheses Testing Based on Ordered p Values—A Historical Survey with Applications to Medical Research
Gerhard Hommel, Frank Bretz & Willi Maurer
Pages: 595-609
Published online: 22 Apr 2011
AbstractforMultiple Hypotheses Testing Based on Ordered p Values—A Historical Survey with Applications to Medical Research | Full Text | References | PDF (165.1 KB)
  • 439 Views
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Article
Addressing Multiplicity Issues of a Composite Endpoint and Its Components in Clinical Trials
Mohammad F. Huque, Mohamed Alosh & Rafia Bhore
Pages: 610-634
Published online: 22 Apr 2011
AbstractforAddressing Multiplicity Issues of a Composite Endpoint and Its Components in Clinical Trials | Full Text | References | PDF (398.8 KB)
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Article
Comparison of Gatekeeping and other Testing Methods for Identifying Superior Drug Combinations in Bifactorial Designs with Isotonic Parameters
Julia N. Soulakova
Pages: 635-649
Published online: 22 Apr 2011
AbstractforComparison of Gatekeeping and other Testing Methods for Identifying Superior Drug Combinations in Bifactorial Designs with Isotonic Parameters | Full Text | References | PDF (204 KB)
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Article
Sample Size Determination in Superiority Clinical Trials with Multiple Co-Primary Correlated Endpoints
Takashi Sozu, Tomoyuki Sugimoto & Toshimitsu Hamasaki
Pages: 650-668
Published online: 22 Apr 2011
AbstractforSample Size Determination in Superiority Clinical Trials with Multiple Co-Primary Correlated Endpoints | Full Text | References | PDF (266.6 KB)
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Article
Multiple Testing Procedures in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product
Brian L. Wiens
Pages: 669-681
Published online: 22 Apr 2011
AbstractforMultiple Testing Procedures in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product | Full Text | References | PDF (164 KB)
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Article
Confidence Regions for Bonferroni-Based Closed Tests Extended to More General Closed Tests
Olivier Guilbaud & Pär Karlsson
Pages: 682-707
Published online: 22 Apr 2011
AbstractforConfidence Regions for Bonferroni-Based Closed Tests Extended to More General Closed Tests | Full Text | References | PDF (222.9 KB)
  • 177 Views
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Article
Simultaneous Confidence Bands for Nonlinear Regression Models with Application to Population Pharmacokinetic Analyses
S. Gsteiger, F. Bretz & W. Liu
Pages: 708-725
Published online: 22 Apr 2011
AbstractforSimultaneous Confidence Bands for Nonlinear Regression Models with Application to Population Pharmacokinetic Analyses | Full Text | References | PDF (495.9 KB)
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Article
Multistage and Mixture Parallel Gatekeeping Procedures in Clinical Trials
Alex Dmitrienko, George Kordzakhia & Ajit C. Tamhane
Pages: 726-747
Published online: 22 Apr 2011
AbstractforMultistage and Mixture Parallel Gatekeeping Procedures in Clinical Trials | Full Text | References | PDF (168.3 KB)
  • 357 Views
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Article
A Mixture Gatekeeping Procedure Based on the Hommel Test for Clinical Trial Applications
Thomas Brechenmacher, Jane Xu, Alex Dmitrienko & Ajit C. Tamhane
Pages: 748-767
Published online: 22 Apr 2011
AbstractforA Mixture Gatekeeping Procedure Based on the Hommel Test for Clinical Trial Applications | Full Text | References | PDF (278.9 KB)
  • 474 Views
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Article
Three Methods for Constructing Parallel Gatekeeping Procedures in Clinical Trials
Alex Dmitrienko, Julia N. Soulakova & Brian A. Millen
Pages: 768-786
Published online: 22 Apr 2011
AbstractforThree Methods for Constructing Parallel Gatekeeping Procedures in Clinical Trials | Full Text | References | PDF (345.3 KB)
  • 310 Views
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Article
Group-Sequential Methods for Adaptive Seamless Phase II/III Clinical Trials
Nigel Stallard
Pages: 787-801
Published online: 22 Apr 2011
AbstractforGroup-Sequential Methods for Adaptive Seamless Phase II/III Clinical Trials | Full Text | References | PDF (216.2 KB)
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Article
On Sample Size Determination in Multi-Armed Confirmatory Adaptive Designs
Gernot Wassmer
Pages: 802-817
Published online: 22 Apr 2011
AbstractforOn Sample Size Determination in Multi-Armed Confirmatory Adaptive Designs | Full Text | References | PDF (255 KB)
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Article
Familywise Error Control in Multi-Armed Response-Adaptive Two-Stage Designs
Georg Gutjahr, Martin Posch & Werner Brannath
Pages: 818-830
Published online: 22 Apr 2011
AbstractforFamilywise Error Control in Multi-Armed Response-Adaptive Two-Stage Designs | Full Text | References | PDF (129.3 KB)
  • 258 Views
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Article
Population Enrichment Designs: Case Study of a Large Multinational Trial
Cyrus R. Mehta & Ping Gao
Pages: 831-845
Published online: 22 Apr 2011
AbstractforPopulation Enrichment Designs: Case Study of a Large Multinational Trial | Full Text | References | PDF (609.7 KB)
  • 367 Views
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Article
Regulatory Perspectives on Multiplicity in Adaptive Design Clinical Trials throughout a Drug Development Program
Sue-Jane Wang, H. M. James Hung & Robert O'Neill
Pages: 846-859
Published online: 22 Apr 2011
AbstractforRegulatory Perspectives on Multiplicity in Adaptive Design Clinical Trials throughout a Drug Development Program | Full Text | References | PDF (110.1 KB)
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Book Reviews

Book Review
A Review of: “Frailty Models in Survival Analysis, by A. Wienke”
Boca Raton, FL: Chapman and Hall/CRC, 2011, ISBN 978-1-4200-7388-1, xxi + 301 pp., $99.95.
William Mietlowski
Pages: 860-862
Published online: 22 Apr 2011
First Page PreviewforA Review of: “Frailty Models in Survival Analysis, by A. Wienke” | Full Text | References | PDF (55 KB)
  • 154 Views
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Book Review
A Review of: Regression With Linear Predictors, by P. K. Andersen and L. T. Skovgaard”
New York: Springer, 2010, ISBN 978-1-4419-7169-2, xi + 494 pp., $84.95.
Dirk F. Moore
Pages: 863-864
Published online: 22 Apr 2011
CitationforA Review of: Regression With Linear Predictors, by P. K. Andersen and L. T. Skovgaard” | Full Text | References | PDF (52.2 KB)
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Book Review
A Review of: Multiple Comparisons Using R, by F. Bretz, T. Hothorn, and P. Westfall”
Boca Raton, FL: Chapman & Hall/CRC, 2011, ISBN 978-1-58488-574-0, xvii + 187 pp., $79.95.
Vera Lisovskaja
Pages: 865-867
Published online: 22 Apr 2011
First Page PreviewforA Review of: Multiple Comparisons Using R, by F. Bretz, T. Hothorn, and P. Westfall” | Full Text | References | PDF (54 KB)
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