Benefit-Risk Analysis for Decision-Making: An Approach
| Autor: | Karthik Gurumurthi, Reuben Domike, G. K. Raju |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Multiple Sclerosis
Operations research Computer science Decision Making Antitubercular Agents 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Tuberculosis Multidrug-Resistant Humans Immunologic Factors Pharmacology (medical) 030212 general & internal medicine Diarylquinolines Drug Approval Pharmacology United States Food and Drug Administration Natalizumab Benefit risk analysis Resistant tuberculosis United States Work (electrical) Risk analysis (engineering) chemistry Explicit analysis Accelerated approval Bedaquiline 030217 neurology & neurosurgery |
| Zdroj: | Clinical Pharmacology & Therapeutics. 100:654-671 |
| ISSN: | 0009-9236 |
| Popis: | The analysis of benefit and risk is an important aspect of decision-making throughout the drug lifecycle. In this work, the use of a benefit-risk analysis approach to support decision-making was explored. The proposed approach builds on the qualitative FDA approach to include a more explicit analysis based on international standards and guidance that enables aggregation and comparison of benefit and risk on a common basis and a lifecycle focus. The approach is demonstrated on six decisions over the lifecycle (e.g. accelerated approval, withdrawal, traditional approval) using two case studies: natalizumab for multiple sclerosis and bedaquiline for multi-drug resistant tuberculosis. This article is protected by copyright. All rights reserved. |
| Databáze: | OpenAIRE |
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