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10 items by relevance
1 PhD Thesis

Benefit-Risk Assessment in Drug Development

Sarac, Sinan

Department of Physics, Technical University of Denmark — 2012

This thesis covers the development, testing and use of an eight-step structured method for data-driven benefit-risk assessment. The aim of this thesis was to create a tailored method for the assessment of clinical data. The focus has been on three major aspects: (i) A simple preliminary method

Year: 2012

Language: English

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2 Journal article

A comprehensive approach to benefit-risk assessment in drug development

Sarac, Sinan B; Rasmussen, Christian H; Rasmussen, Morten A.; Hallgreen, Christine E.; Søeborg, Tue; Colding-Jørgensen, Morten; et al. (3 more)

Basic and Clinical Pharmacology and Toxicology — 2012, Volume 111, Issue 1, pp. 65-72

Major regulatory agencies, for example, FDA and EMA, have started to request comprehensive benefit-risk analyses of pharmaceutical products prior to approval or labelling expansion. The purpose of this study is to develop a generally applicable and reliable data-driven benefit-risk assessment

Year: 2012

Language: English

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