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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. Among authors: noel r. Ther Innov Regul Sci. 2016 Sep;50(5):546-553. doi: 10.1177/2168479016662902. Ther Innov Regul Sci. 2016. PMID: 30231755
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. 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.
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. Among authors: noel r. 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.
302 results