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Research article

First published 2017-7

Structured Benefit-Risk Assessment Across the Product Lifecycle

Meredith Y. Smith, Isma Benattia, Carmit Strauss [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-9

Structured Approaches to Benefit-Risk Assessment

Bennett Levitan, Lawrence D. Phillips, Stuart Walker

Therapeutic Innovation & Regulatory Science

Open access

Review article

First published 2020

Structured benefit–risk evaluation for medicinal products: review of quantitative benefit–risk assessment findings in the literature

Marie-Laure Kürzinger, Ludivine Douarin, Ievgeniia Uzun [...]

Therapeutic Advances in Drug Safety

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Research article

First published 2016-11

Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications

JuAn Wang, Anne Wolka, Kristin Bullok [...]

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2023

Patient-perceived benefits and risks of off-label use of SGLT2 inhibitors and GLP-1 receptor agonists in type 1 diabetes: a structured qualitative assessment

Khary Edwards, Aleksandra Uruska, Anna Duda-Sobczak [...]

Therapeutic Advances in Endocrinology and Metabolism

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Research article

First published 2017-9

On a Stepwise Quantitative Approach for Benefit-Risk Assessment

Weili He, Yaxuan Sun, Qing Li [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-1

Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications

Anne Wolka, Margaret Warner, Kristin Bullok [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-9

The Benefit-Risk Assessment of Medicines

Neil McAuslane, James Leong, Lawrence Liberti [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-5

Benefit-Risk Evaluation and Decision Making

Michael W. Colopy, C. V. Damaraju, Weili He [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-9

Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses

Laurel M. Fisher, Amy S. Martinez, Frances J. Richmond [...]

Therapeutic Innovation & Regulatory Science

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