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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 2016-5

Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report

Margaret R. Warner, Anne M. Wolka, Rebecca A. Noel

Therapeutic Innovation & Regulatory Science

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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 2015-1

A Universal Framework for the Benefit-Risk Assessment of Medicines

Stuart Walker, Neil McAuslane, Lawrence Liberti [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 1993-10

Risk/Benefit Assessment: The “Greased Pig” of Drug Development

Loren L. Miller

Therapeutic Innovation & Regulatory Science

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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 2016-11

Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications

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

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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Other

First published 1993-10

Risk/Benefit Assessment of New Drugs: Perspectives of a Former FDA Advisory Committee Member

James H. Lewis

Therapeutic Innovation & Regulatory Science

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Other

First published 2008-5

Bioinformatics Modernization and the Critical Path to Improved Benefit-Risk Assessment of Drugs

Armando Oliva, Randy Levin, Rachel Behrman [...]

Therapeutic Innovation & Regulatory Science

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