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Safety differentiation: emerging competitive edge in drug development


Uteng, Marianne; Urban, Laszlo; Brees, Dominique; Muller, Patrick Y; Kullak-Ublick, Gerd A; Bouchard, Page; Tougas, Gervais; Chibout, Salah-Dine (2019). Safety differentiation: emerging competitive edge in drug development. Drug Discovery Today, 24(1):285-292.

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.

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.

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Additional indexing

Item Type:Journal Article, refereed, further contribution
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Clinical Pharmacology and Toxicology
Dewey Decimal Classification:610 Medicine & health
Uncontrolled Keywords:Pharmacology, Drug Discovery
Language:English
Date:1 January 2019
Deposited On:30 Oct 2018 14:49
Last Modified:11 Feb 2019 02:02
Publisher:Elsevier
ISSN:1359-6446
OA Status:Closed
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1016/j.drudis.2018.09.009
PubMed ID:30244081

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Content: Accepted Version
Filetype: PDF - Registered users only until 18 September 2019
Size: 291kB
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Embargo till: 2019-09-18