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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: bucci rechtweg c. 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.
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.
Wang J, Johnson T, Sahin L, Tassinari MS, Anderson PO, Baker TE, Bucci-Rechtweg C, Burckart GJ, Chambers CD, Hale TW, Johnson-Lyles D, Nelson RM, Nguyen C, Pica-Branco D, Ren Z, Sachs H, Sauberan J, Zajicek A, Ito S, Yao LP. Wang J, et al. Clin Pharmacol Ther. 2017 Jun;101(6):736-744. doi: 10.1002/cpt.676. Clin Pharmacol Ther. 2017. PMID: 28510297 Free PMC article. Review.
Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.
Offringa M, Davis JM, Turner MA, Ward R, Bax R, Maldonado S, Sinha V, McCune SK, Zajicek A, Benjamin DK Jr, Bucci-Rechtweg C, Nelson RM. Offringa M, et al. Ther Innov Regul Sci. 2015 Sep;49(5):623-631. doi: 10.1177/2168479015597730. Ther Innov Regul Sci. 2015. PMID: 30227031
Tiny and Forgotten: A Call for Focused Neonatal Policy Reform.
Bucci-Rechtweg CM, Ward RM. Bucci-Rechtweg CM, et al. Ther Innov Regul Sci. 2019 Sep;53(5):615-617. doi: 10.1177/2168479018821922. Epub 2019 Jan 8. Ther Innov Regul Sci. 2019. PMID: 30621453 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. Among authors: bucci rechtweg c. 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
How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.
Severin T, Corriol-Rohou S, Bucci-Rechtweg C, An Haack K, Fuerst-Recktenwald S, Lepola P, Norjavaara E, Dehlinger-Kremer M; EFGCP Children’s Medicines Working Party; Haertter S, Cheung SYA; IQ Pediatric Working Group. Severin T, et al. Among authors: bucci rechtweg c. Ther Innov Regul Sci. 2020 Sep;54(5):1076-1084. doi: 10.1007/s43441-020-00116-4. Epub 2020 Feb 6. Ther Innov Regul Sci. 2020. PMID: 32030690 Free PMC article.
Correction to: How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.
Severin T, Corriol-Rohou S, Bucci-Rechtweg C, An Haack K, Fuerst-Recktenwald S, Lepola P, Norjavaara E, Dehlinger-Kremer M; EFGCP Children’s Medicines Working Party; Haertter S, Cheung SYA; IQ Pediatric Working Group. Severin T, et al. Among authors: bucci rechtweg c. Ther Innov Regul Sci. 2020 Sep;54(5):1085. doi: 10.1007/s43441-020-00152-0. Ther Innov Regul Sci. 2020. PMID: 32865808 Free PMC article.
36 results