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Informed consent and assent guide for paediatric clinical trials in Europe.
Lepola P, Kindred M, Giannuzzi V, Glosli H, Dehlinger-Kremer M, Dalrymple H, Neubauer D, Boylan GB, Conway J, Dewhurst J, Hoffman D. Lepola P, et al. Among authors: dehlinger kremer m. Arch Dis Child. 2022 Jun;107(6):582-590. doi: 10.1136/archdischild-2021-322798. Epub 2021 Dec 1. Arch Dis Child. 2022. PMID: 34853000 Free PMC article.
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: dehlinger kremer m. 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: dehlinger kremer m. 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.
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance.
Bucci-Rechtweg C, Siapkara A, An Haack Bonnet K, Corriol Rohou S, Haf Davies E, Dehlinger Kremer M, Gamalo M, Moreno C, Nelson RM, Thomas Turner R. Bucci-Rechtweg C, et al. Among authors: dehlinger kremer m. Clin Trials. 2023 Feb;20(1):13-21. doi: 10.1177/17407745221132302. Epub 2022 Nov 5. Clin Trials. 2023. PMID: 36341541
11 results