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Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum.
Noel GJ, Nelson RM, Bucci-Rechtweg C, Portman R, Miller T, Green DJ, Snyder D, Moreno C, Hovinga C, Connor E. Noel GJ, et al. Among authors: portman r. Ther Innov Regul Sci. 2021 Jul;55(4):773-778. doi: 10.1007/s43441-021-00283-y. Epub 2021 Apr 2. Ther Innov Regul Sci. 2021. PMID: 33811302 Free PMC article.
Extrapolation as a Default Strategy in Pediatric Drug Development.
Gamalo M, Bucci-Rechtweg C, Nelson RM, Vanh L, Porcalla A, Thackray H, Cooner F, Cutler L, Friend D, Portman R. Gamalo M, et al. Among authors: portman r. Ther Innov Regul Sci. 2022 Nov;56(6):883-894. doi: 10.1007/s43441-021-00367-9. Epub 2022 Jan 10. Ther Innov Regul Sci. 2022. PMID: 35006587
Enrollment of Neonates in More Than One Clinical Trial.
Davis JM, Baer GR, Portman R, Nelson R, Storari L, Aranda JV, Bax R, Zajicek A, Klein A, Turner M, Baygani S, Thomson M, Allegaert K; International Neonatal Consortium. Davis JM, et al. Among authors: portman r. Clin Ther. 2017 Oct;39(10):1959-1969. doi: 10.1016/j.clinthera.2017.09.006. Epub 2017 Oct 4. Clin Ther. 2017. PMID: 28987269 Free article. Review.
Special article: 2014 Pediatric Clinical Trials Forum.
Bogue C, DiMeglio LA, Maldonado S, Portman RJ, Smith PB, Sullivan JE, Thompson C, Woo H, Flinn S. Bogue C, et al. Pediatr Res. 2016 Apr;79(4):662-9. doi: 10.1038/pr.2015.255. Epub 2015 Dec 9. Pediatr Res. 2016. PMID: 26650344
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.
Fleming TR, Garnett CE, Conklin LS, Corriol-Rohou S, Hariharan S, Hsu D, Mueller-Velten G, Mulugeta Y, Portman R, Rothmann MD, Stockbridge NL, Wandel S, Zhang J, Yao L. Fleming TR, et al. Among authors: portman r. Ther Innov Regul Sci. 2023 Jan;57(1):109-120. doi: 10.1007/s43441-022-00445-6. Epub 2022 Sep 3. Ther Innov Regul Sci. 2023. PMID: 36057747 Free PMC article.
Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank.
Torok RD, Li JS, Kannankeril PJ, Atz AM, Bishai R, Bolotin E, Breitenstein S, Chen C, Diacovo T, Feltes T, Furlong P, Hanna M, Graham EM, Hsu D, Ivy DD, Murphy D, Kammerman LA, Kearns G, Lawrence J, Lebeaut B, Li D, Male C, McCrindle B, Mugnier P, Newburger JW, Pearson GD, Peiris V, Percival L, Pina M, Portman R, Shaddy R, Stockbridge NL, Temple R, Hill KD. Torok RD, et al. Among authors: portman r. J Am Heart Assoc. 2018 Feb 10;7(4):e007283. doi: 10.1161/JAHA.117.007283. J Am Heart Assoc. 2018. PMID: 29440007 Free PMC article. No abstract available.
146 results