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Navigating the challenges of initiating pediatric device trials - a case study.
Hunter RB, Willson RC, Haridas B, Luk C, Toman K, Heffernan MJ, Fischer G, Wettergreen M, Koh CJ. Hunter RB, et al. Among authors: koh cj. J Clin Transl Sci. 2024 May 13;8(1):e97. doi: 10.1017/cts.2024.539. eCollection 2024. J Clin Transl Sci. 2024. PMID: 39588484 Free PMC article.
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. 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.
Pediatric Device Clinical Trials Activity: 1999-2022.
Dienstman J, Stachelek SJ, Krieger AM, Eskandanian K, Espinoza JC, Harrison MR, Koh CJ, Peiris V, Torjusen E, Levy RJ. Dienstman J, et al. Among authors: koh cj. Pediatrics. 2024 Aug 1;154(2):e2023063466. doi: 10.1542/peds.2023-063466. Pediatrics. 2024. PMID: 38953121
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: koh cj. 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.
Editorial Comment.
Yong RT, Nguyen CT, Koh CJ. Yong RT, et al. Among authors: koh cj. J Urol. 2023 Dec;210(6):886-887. doi: 10.1097/JU.0000000000003696.01. Epub 2023 Oct 2. J Urol. 2023. PMID: 37782915 No abstract available.
Fetal lower urinary tract obstruction: international Delphi consensus on management and core outcome set.
Mustafa HJ, Khalil A, Johnson S, Gordijn SJ, Ganzevoort W, Melling C, Koh CJ, Mandy GT, Kilby MD, Johnson A, Quintero RA, Ryan G, Shamshirsaz AA, Nassr AA;  on behalf of the LUTO Working Group. Mustafa HJ, et al. Among authors: koh cj. Ultrasound Obstet Gynecol. 2024 Nov;64(5):635-650. doi: 10.1002/uog.27684. Ultrasound Obstet Gynecol. 2024. PMID: 38748971 Free PMC article.
172 results