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Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.
Sanger T, Chang A, Feaster W, Taraman S, Afari N, Beauregard D, Dethlefs B, Ghere T, Kabeer M, Tolomiczenko G, Billig M, Brophy J, Eskandanian K, Espinoza J, Farrugia S, Harrison M, Horvat C, Hoyen C, Koh C, Komiyama A, Nelson K, Kulkarni O, Levy R, Maher K, O'Donnell M, Ponsky T, Richmond F, Richter J, Roy S, Samir S, Suresh S, Stallworth C, Thekkedath U, Toman K, Wall J, West L, Wolff D. Sanger T, et al. Among authors: west l. IEEE J Transl Eng Health Med. 2021 Jun 25;9:4800105. doi: 10.1109/JTEHM.2021.3092559. eCollection 2021. IEEE J Transl Eng Health Med. 2021. PMID: 34327067 Free PMC article.
Role of Patients and Parents in Pediatric Drug Development.
Tsang VWL, West L, Woods C, Koh CJ, McCune S, Mullin T, Smith SR, Gaillard S, Claverol J, Nafria B, Preston J, Dicks P, Thompson C. Tsang VWL, et al. Among authors: west l. Ther Innov Regul Sci. 2019 Sep;53(5):601-608. doi: 10.1177/2168479018820875. Epub 2019 Jan 20. Ther Innov Regul Sci. 2019. PMID: 30663334 Free PMC article.
Application of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population.
Maglalang PD, Sinha J, Zimmerman K, McCann S, Edginton A, Hornik CP, Hornik CD, Muller WJ, Al-Uzri A, Meyer M, Chen JY, Anand R, Perrin EM, Gonzalez D; Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee. Maglalang PD, et al. Clin Pharmacokinet. 2024 May 30. doi: 10.1007/s40262-024-01367-2. Online ahead of print. Clin Pharmacokinet. 2024. PMID: 38814425
684 results