Statistics in Biopharmaceutical Research, Volume 13, Issue 1 (2021)

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Statistics in Biopharmaceutical Research, Volume 13, Issue 1 (2021)

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Special Section on Roles of Hypothesis Testing, p-Values, and Decision-Making in Biopharmaceutical Research

Editorial
Editorial: Roles of Hypothesis Testing, p-Values and Decision Making in Biopharmaceutical Research
Toshimitsu Hamasaki, Frank Bretz, Lisa M. LaVange, Peter Müller, Gene Pennello & José C. Pinheiro
Pages: 1-5
Published online: 19 Feb 2021
AbstractforEditorial: Roles of Hypothesis Testing, p-Values and Decision Making in Biopharmaceutical Research | Full Text | References | PDF (522.2 KB) | EPUB
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Article
The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations
Eric W. Gibson
Pages: 6-18
Published online: 23 Jun 2020
AbstractforThe Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations | Full Text | References | PDF (1.6 MB) | EPUB
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Waking up to p: Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Scott R. Evans
Pages: 19-21
Published online: 19 Feb 2021
First Page PreviewforWaking up to p: Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (372.6 KB) | EPUB
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It’s the Selection’s Fault—Not the p-Values’: A Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Yoav Benjamini & Yoav Zeevi
Pages: 22-25
Published online: 23 Dec 2020
First Page PreviewforIt’s the Selection’s Fault—Not the p-Values’: A Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (845.6 KB) | EPUB
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Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Tosiya Shun Sato
Pages: 26-27
Published online: 19 Feb 2021
CitationforComment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (432.7 KB) | EPUB
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Is the p-Value a Suitable Basis for the Construction of Measures of Evidence? Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Stefan Wellek & Maria Blettner
Pages: 28-29
Published online: 05 Nov 2020
CitationforIs the p-Value a Suitable Basis for the Construction of Measures of Evidence? Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (290.4 KB) | EPUB
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p-Value, Hypothesis Testing, Strength of Evidence: Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
H. M. James Hung, John Lawrence & Sue-Jane Wang
Pages: 30-31
Published online: 19 Feb 2021
Citationforp-Value, Hypothesis Testing, Strength of Evidence: Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (293.3 KB) | EPUB
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The p-Value: Guilty by Association
Rob Hemmings
Pages: 32-35
Published online: 19 Feb 2021
First Page PreviewforThe p-Value: Guilty by Association | Full Text | References | PDF (431.3 KB) | EPUB
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p-Values and Replicability: A Commentary on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Christy Chuang-Stein & Simon Kirby
Pages: 36-39
Published online: 19 Feb 2021
First Page Previewforp-Values and Replicability: A Commentary on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (438.9 KB) | EPUB
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Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
C. Glenn Begley & Steven M. Snapinn
Pages: 40-42
Published online: 19 Feb 2021
First Page PreviewforComment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (367.8 KB) | EPUB
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Are p-values Useful to Judge the Evidence Against the Null Hypotheses in Complex Clinical Trials? A Comment on “The Role of p-values in Judging the Strength of Evidence and Realistic Replication Expectations”
Martin Posch & Franz König
Pages: 43-45
Published online: 23 Dec 2020
First Page PreviewforAre p-values Useful to Judge the Evidence Against the Null Hypotheses in Complex Clinical Trials? A Comment on “The Role of p-values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (366.6 KB) | EPUB
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Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Leonhard Held & Samuel Pawel
Pages: 46-48
Published online: 05 Nov 2020
First Page PreviewforComment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (367.3 KB) | EPUB
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A Bayesian Posterior Probability Is the Real Replication Probability
Stephen J. Ruberg
Pages: 49-54
Published online: 05 Nov 2020
First Page PreviewforA Bayesian Posterior Probability Is the Real Replication Probability | Full Text | References | PDF (611 KB) | EPUB
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Rejoinder to Commentaries on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”
Eric W. Gibson
Pages: 55-56
Published online: 19 Feb 2021
CitationforRejoinder to Commentaries on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations” | Full Text | References | PDF (345.9 KB) | EPUB
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Open Access
Letter
Statement on P-values
Thomas Gwise, Mark D. Rothmann, H.M. James Hung, Anup Amatya, Rebecca Rothwell, Sue Jane Wang, Yute Wu, Fraser Smith, Yu-Ting Weng, Eugenio Andraca-Carrera, Stella Grosser, Somesh Chattopadhyay & Sylva H. Collins
Pages: 57-58
Published online: 19 Feb 2021
CitationforStatement on P-values | Full Text | References | PDF (298.4 KB) | EPUB
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Articles

Article
Methods for Non-Compartmental Pharmacokinetic Analysis With Observations Below the Limit of Quantification
Helen Yvette Barnett, Helena Geys, Tom Jacobs & Thomas Jaki
Pages: 59-70
Published online: 21 Jan 2020
AbstractforMethods for Non-Compartmental Pharmacokinetic Analysis With Observations Below the Limit of Quantification | Full Text | References | PDF (2.1 MB) | EPUB | Supplemental
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Article
Optimal Designs for Multi-Arm Phase II/III Drug Development Programs
Stella Preussler, Marietta Kirchner, Heiko Götte & Meinhard Kieser
Pages: 71-81
Published online: 30 Jan 2020
AbstractforOptimal Designs for Multi-Arm Phase II/III Drug Development Programs | Full Text | References | PDF (1.9 MB) | EPUB | Supplemental
  • 300 Views
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Article
Statistical Evaluation of Four Central Reading Processes
Chunpeng Fan & Lynn Wei
Pages: 82-90
Published online: 14 Feb 2020
AbstractforStatistical Evaluation of Four Central Reading Processes | Full Text | References | PDF (1.3 MB) | EPUB
  • 101 Views
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Article
Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints
Taehee Lee & Seung-Ho Kang
Pages: 91-105
Published online: 19 Feb 2020
AbstractforStatistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
  • 214 Views
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Article
Testing Procedures for Claiming Success on at Least k Out of m Hypotheses with an Application to Biosimilar Development
Johanna Mielke, Byron Jones, Martin Posch & Franz König
Pages: 106-112
Published online: 30 Mar 2020
AbstractforTesting Procedures for Claiming Success on at Least k Out of m Hypotheses with an Application to Biosimilar Development | Full Text | References | PDF (1 MB) | EPUB | Supplemental
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Article
A Simple Mantel–Haenszel Type Test for Noninferiority
Kallappa M. Koti
Pages: 113-118
Published online: 01 Apr 2020
AbstractforA Simple Mantel–Haenszel Type Test for Noninferiority | Full Text | References | PDF (611.7 KB) | EPUB
  • 269 Views
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Article
The Use of a Variable Representing Compliance Improves Accuracy of Estimation of the Effect of Treatment Allocation Regardless of Discontinuation in Trials with Incomplete Follow-up
Lorenzo Guizzaro, Frank Pétavy, Robin Ristl & Ciro Gallo
Pages: 119-127
Published online: 17 Apr 2020
AbstractforThe Use of a Variable Representing Compliance Improves Accuracy of Estimation of the Effect of Treatment Allocation Regardless of Discontinuation in Trials with Incomplete Follow-up | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
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Open Access

Editorial Collaborators

Editorial
Editorial Collaborators
Page: ebi
Published online: 19 Feb 2021
CitationforEditorial Collaborators | Full Text | PDF (212.4 KB) | EPUB
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