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Recommendations for benefit-risk assessment methodologies and visual representations.
Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey GF, Hallgreen CE, Hockley KS, Juhaeri J, Lieftucht A, Metcalf MA, Noel RA, Phillips LD, Ashby D, Micaleff A; PROTECT Benefit-Risk Group. Hughes D, et al. Among authors: noel ra. Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):251-62. doi: 10.1002/pds.3958. Epub 2016 Jan 22. Pharmacoepidemiol Drug Saf. 2016. PMID: 26800458 Free article.
Balancing benefit and risk of medicines: a systematic review and classification of available methodologies.
Mt-Isa S, Hallgreen CE, Wang N, Callréus T, Genov G, Hirsch I, Hobbiger SF, Hockley KS, Luciani D, Phillips LD, Quartey G, Sarac SB, Stoeckert I, Tzoulaki I, Micaleff A, Ashby D; IMI-PROTECT benefit-risk participants. Mt-Isa S, et al. Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):667-78. doi: 10.1002/pds.3636. Epub 2014 May 13. Pharmacoepidemiol Drug Saf. 2014. PMID: 24821575 Review.
Literature review of visual representation of the results of benefit-risk assessments of medicinal products.
Hallgreen CE, Mt-Isa S, Lieftucht A, Phillips LD, Hughes D, Talbot S, Asiimwe A, Downey G, Genov G, Hermann R, Noel R, Peters R, Micaleff A, Tzoulaki I, Ashby D; PROTECT Benefit-Risk group. Hallgreen CE, et al. Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):238-50. doi: 10.1002/pds.3880. Epub 2015 Nov 2. Pharmacoepidemiol Drug Saf. 2016. PMID: 26521865 Free article. Review.
Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.
Pignatti F, Ashby D, Brass EP, Eichler HG, Frey P, Hillege HL, Hori A, Levitan B, Liberti L, Löfstedt RE, McAuslane N, Micaleff A, Noel RA, Postmus D, Renn O, Sabourin BJ, Salmonson T, Walker S. Pignatti F, et al. Among authors: noel ra. Clin Pharmacol Ther. 2015 Nov;98(5):522-33. doi: 10.1002/cpt.203. Epub 2015 Sep 11. Clin Pharmacol Ther. 2015. PMID: 26261064 Free article. Review.
Patient Engagement at a Tipping Point-The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, "Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products".
Smith MY, Hammad TA, Metcalf M, Levitan B, Noel R, Wolka AM, Michaels DL, Johnson FR. Smith MY, et al. Ther Innov Regul Sci. 2016 Sep;50(5):546-553. doi: 10.1177/2168479016662902. Ther Innov Regul Sci. 2016. PMID: 30231755
34 results