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Safety differentiation: emerging competitive edge in drug development.
- Source :
-
Drug discovery today [Drug Discov Today] 2019 Jan; Vol. 24 (1), pp. 285-292. Date of Electronic Publication: 2018 Sep 19. - Publication Year :
- 2019
-
Abstract
- With increasing expectations to provide evidence of drug efficacy, safety, and cost-effectiveness, best-in-class drugs are a major value driver for the pharmaceutical industry. Superior safety is a key differentiation criterion that could be achieved through better risk:benefit profiles, safety margins, fewer contraindications, and improved patient compliance. To accomplish this, comparative safety assessments using innovative and adaptive nonclinical and clinical outcome-based approaches should be undertaken, and continuous strategic adjustments must be made as the risk:benefit profiles evolve. Key success criteria include scientific expertise and integration between all disciplines during the full extent of the drug development process.<br /> (Copyright © 2018 Elsevier Ltd. All rights reserved.)
Details
- Language :
- English
- ISSN :
- 1878-5832
- Volume :
- 24
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Drug discovery today
- Publication Type :
- Academic Journal
- Accession number :
- 30244081
- Full Text :
- https://doi.org/10.1016/j.drudis.2018.09.009