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Review
. 2017 Mar;10(2):78-83.
doi: 10.1111/cts.12439. Epub 2017 Feb 3.

Leveraging Genomic Factors to Improve Benefit-Risk

R N Schuck  1 , R Charlab  1 , G M Blumenthal  1
Affiliations
Review

Leveraging Genomic Factors to Improve Benefit-Risk

R N Schuck et al. Clin Transl Sci. 2017 Mar.
No abstract available

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Figures

Figure 1
Figure 1
Genomic factors may be utilized to decrease risk and/or increase benefit. Decreasing arrow size represents decreasing risk and increasing arrow size represents increasing benefit. Either reducing risk or increasing benefit can result in a more favorable benefit–risk profile, and a greater likelihood of approvability.
See this image and copyright information in PMC

References

    1. Tremaine, L. et al The role of adme pharmacogenomics in early clinical trials: Perspective of the industry pharmacogenomics working group (i‐pwg). Pharmacogenomics. 18, 2055–2067 (2015). - PMC - PubMed
    1. Squassina, A. et al Realities and expectations of pharmacogenomics and personalized medicine: Impact of translating genetic knowledge into clinical practice. Pharmacogenomics. 8, 1149–1167 (2010). - PubMed
    1. FDA‐NIH Biomarker Working Group . BEST (Biomarkers, EndpointS, and other Tools) Resource (Internet). Silver Spring (MD): Food and Drug Administration (US); 2016‐. Glossary. 2016. Jan 28 (Updated 2016 Apr 28). Available from: https://www.ncbi.nlm.nih.gov/books/NBK338448/ Co‐published by National Institutes of Health (US), Bethesda (MD). - PubMed
    1. Zineh, I. & Pacanowski, M.A. Pharmacogenomics in the assessment of therapeutic risks versus benefits: Inside the United States Food and Drug Administration. Pharmacotherapy. 8, 729–735 (2011). - PubMed
    1. Pacanowski, M.A. , Leptak, C. & Zineh, I. Next‐generation medicines: Past regulatory experience and considerations for the future. Clin. Pharmacol. Ther. 3, 247–249 (2014). - PubMed

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