Statistics in Biopharmaceutical Research, Volume 8, Issue 4 (2016)

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Statistics in Biopharmaceutical Research, Volume 8, Issue 4 (2016)

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Practical Considerations and Approaches for Emerging Issues in Benefit-Risk Assessment of Medical Products

Guest Editors’ Note

Editorial
Practical Considerations and Approaches for Emerging Issues in Benefit-risk Assessment of Medical Products
Weili He, Ivan Chan & Qi Jiang
Page: 365
Published online: 06 Dec 2016
CitationforPractical Considerations and Approaches for Emerging Issues in Benefit-risk Assessment of Medical Products | Full Text | References | PDF (108.2 KB)
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Original Articles

Article
Key Changes in Benefit–Risk Assessment Guidelines and Implications for Data Analysis in Drug Development
Tarek A. Hammad & Cathy Anne Pinto
Pages: 366-372
Published online: 06 Dec 2016
AbstractforKey Changes in Benefit–Risk Assessment Guidelines and Implications for Data Analysis in Drug Development | Full Text | References | PDF (391 KB)
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Article
A Quantitative Approach for Benefit-Risk Assessment Using Stochastic Multi-Criteria Discriminatory Method
Yaping Wang, Yabing Mai & Weili He
Pages: 373-378
Published online: 06 Dec 2016
AbstractforA Quantitative Approach for Benefit-Risk Assessment Using Stochastic Multi-Criteria Discriminatory Method | Full Text | References | PDF (374.8 KB)
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Article
Benefit–Risk Assessment Using Number Needed to Treat and Number Needed to Harm for Time-to-Event Endpoints
Chunlei Ke & Qi Jiang
Pages: 379-385
Published online: 06 Dec 2016
AbstractforBenefit–Risk Assessment Using Number Needed to Treat and Number Needed to Harm for Time-to-Event Endpoints | Full Text | References | PDF (514.8 KB)
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Article
Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step Toward Pragmatism in Benefit:Risk Evaluation
Scott R. Evans & Dean Follmann
Pages: 386-393
Published online: 06 Dec 2016
AbstractforUsing Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step Toward Pragmatism in Benefit:Risk Evaluation | Full Text | References | PDF (412.6 KB)
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Article
Selecting and Integrating Data Sources in Benefit–Risk Assessment: Considerations and Future Directions
Rachael L. DiSantostefano, Jesse A. Berlin, Christy Chuang-Stein, George Quartey, Gary Eichenbaum & Bennett Levitan
Pages: 394-403
Published online: 31 Aug 2016
AbstractforSelecting and Integrating Data Sources in Benefit–Risk Assessment: Considerations and Future Directions | Full Text | References | PDF (446.8 KB)
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Article
Perspective: Multiplicity and Subgroups in the Context of Benefit–Risk Assessment
Jonathan D. Norton, Ramin Arani, Weili He, Qi Jiang, Shihua Wen & Christy Chuang-Stein
Pages: 404-408
Published online: 30 Aug 2016
AbstractforPerspective: Multiplicity and Subgroups in the Context of Benefit–Risk Assessment | Full Text | References | PDF (358.2 KB)
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Article
Practical Analysis and Visualization Tools for Benefit-Risk Assessment in Drug Development: A Review of Recent FDA Advisory Committee Meeting Packages
Shihua Wen , Weili He, Scott R. Evans, George Quartey, Jonathan D. Norton, Christy Chuang-Stein, Qi Jiang, Haijun Ma & Mondira Bhattacharya
Pages: 409-416
Published online: 13 Sep 2016
AbstractforPractical Analysis and Visualization Tools for Benefit-Risk Assessment in Drug Development: A Review of Recent FDA Advisory Committee Meeting Packages | Full Text | References | PDF (719 KB)
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Article
Considerations on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment of Medical Product
Haijun Ma, Qi Jiang, Christy Chuang-Stein, Scott R. Evans, Weili He, George Quartey, John Scott, Shihua Wen & Ramin Arani
Pages: 417-425
Published online: 21 Sep 2016
AbstractforConsiderations on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment of Medical Product | Full Text | References | PDF (702 KB)
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Comments

Discussion
Comment: Statisticians Staying Involved in Benefit-Risk Assessment
John Scott
Pages: 426-427
Published online: 06 Dec 2016
CitationforComment: Statisticians Staying Involved in Benefit-Risk Assessment | Full Text | References | PDF (222.8 KB)
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Corrigenda

Correction
Corrigendum
Page: 428
Published online: 06 Dec 2016
CitationforCorrigendum | Full Text | PDF (74.5 KB)
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Indices

Index
Editorial Board
Page: ebi
Published online: 06 Dec 2016
CitationforEditorial Board | Full Text | PDF (20 KB)
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