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101 results

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Page 1
Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
Davis JM, Baer GR, McCune S, Klein A, Sato J, Fabbri L, Mangili A, Short MA, Tansey S, Mangum B, Hokuto I, Nakamura H, Salaets T, Allegaert K, Yao L, Blum M, Toerner J, Turner M, Portman R; International Neonatal Consortium. Davis JM, et al. J Pediatr. 2020 Apr;219:243-249.e1. doi: 10.1016/j.jpeds.2019.09.060. Epub 2019 Nov 8. J Pediatr. 2020. PMID: 31708158 Free PMC article. No abstract available.
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. 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
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. 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. 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.
New Horizons in Pediatric Drug Development.
Spielberg SP, Portman R. Spielberg SP, et al. Ther Innov Regul Sci. 2015 Sep;49(5):613-614. doi: 10.1177/2168479015600724. Ther Innov Regul Sci. 2015. PMID: 30227028 No abstract available.
101 results