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Page 1
The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement.
Stegall MD, Troy Somerville K, Everly MJ, Mannon RB, Gaber AO, First MR, Agashivala N, Perez V, Newell KA, Morris RE, Sudan D, Romero K, Eremenco S, Mattera M, Spear N, Porter AC, O'Doherty I. Stegall MD, et al. Am J Transplant. 2019 Mar;19(3):625-632. doi: 10.1111/ajt.15214. Epub 2019 Jan 23. Am J Transplant. 2019. PMID: 30549395 Free article.
Recommended Treatment for Antibody-mediated Rejection After Kidney Transplantation: The 2019 Expert Consensus From the Transplantion Society Working Group.
Schinstock CA, Mannon RB, Budde K, Chong AS, Haas M, Knechtle S, Lefaucheur C, Montgomery RA, Nickerson P, Tullius SG, Ahn C, Askar M, Crespo M, Chadban SJ, Feng S, Jordan SC, Man K, Mengel M, Morris RE, O'Doherty I, Ozdemir BH, Seron D, Tambur AR, Tanabe K, Taupin JL, O'Connell PJ. Schinstock CA, et al. Transplantation. 2020 May;104(5):911-922. doi: 10.1097/TP.0000000000003095. Transplantation. 2020. PMID: 31895348 Free PMC article. Review.
Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report.
Mannon RB, Morris RE, Abecassis M, Axelrod D, Bala S, Friedman GS, Heeger PS, Lentine KL, Loupy A, Murphy B, Nickerson P, Sarwal M, O'Doherty I, Spear N, Karpen SR. Mannon RB, et al. Among authors: o doherty i. Am J Transplant. 2020 Jun;20(6):1495-1502. doi: 10.1111/ajt.15833. Epub 2020 Mar 17. Am J Transplant. 2020. PMID: 32090461 Free article.
Effective Data Sharing as a Conduit for Advancing Medical Product Development.
Karpen SR, White JK, Mullin AP, O'Doherty I, Hudson LD, Romero K, Sivakumaran S, Stephenson D, Turner EC, Larkindale J. Karpen SR, et al. Among authors: o doherty i. Ther Innov Regul Sci. 2021 May;55(3):591-600. doi: 10.1007/s43441-020-00255-8. Epub 2021 Jan 4. Ther Innov Regul Sci. 2021. PMID: 33398663 Free PMC article. Review.
The Role of Patient-reported Outcomes and Medication Adherence Assessment in Patient-focused Drug Development for Solid Organ Transplantation.
Karpen SR, Klein A, Alloway RR, Albrecht R, Belen O, Campbell M, Kluetz P, Minasian LM, Mitchell SA, O'Doherty I, Papadopoulos E, Sapir-Pichhadze R, Spear N, van Gelder T, Velidedeoglu E, Page CA, Everly MJ. Karpen SR, et al. Among authors: o doherty i. Transplantation. 2021 May 1;105(5):941-944. doi: 10.1097/TP.0000000000003556. Transplantation. 2021. PMID: 33901129 No abstract available.
Leveraging Real-World Data for EMA Qualification of a Model-Based Biomarker Tool to Optimize Type-1 Diabetes Prevention Studies.
Podichetty JT, Lang P, O'Doherty IM, David SE, Muse RN, Karpen SR, Song LS, Romero K, Burton JK; Type-1 Diabetes Consortium (T1DC). Podichetty JT, et al. Among authors: o doherty im. Clin Pharmacol Ther. 2022 May;111(5):1133-1141. doi: 10.1002/cpt.2559. Epub 2022 Mar 11. Clin Pharmacol Ther. 2022. PMID: 35276013 Free PMC article.
Disease progression joint model predicts time to type 1 diabetes onset: Optimizing future type 1 diabetes prevention studies.
Morales JF, Muse R, Podichetty JT, Burton J, David S, Lang P, Schmidt S, Romero K, O'Doherty I, Martin F, Campbell-Thompson M, Haller MJ, Atkinson MA, Kim S. Morales JF, et al. Among authors: o doherty i. CPT Pharmacometrics Syst Pharmacol. 2023 Jul;12(7):1016-1028. doi: 10.1002/psp4.12973. Epub 2023 May 3. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 37186151 Free PMC article.
Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation.
Kosinski L, Frey E, Klein A, O'Doherty I, Romero K, Stegall M, Helanterä I, Gaber AO, Fitzsimmons WE, Aggarwal V; Transplant Therapeutics Consortium (TTC). Kosinski L, et al. Among authors: o doherty i. Clin Transl Sci. 2023 Sep;16(9):1680-1690. doi: 10.1111/cts.13579. Epub 2023 Jul 10. Clin Transl Sci. 2023. PMID: 37350196 Free PMC article.
Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes.
Klein A, Loupy A, Stegall M, Helanterä I, Kosinski L, Frey E, Aubert O, Divard G, Newell K, Meier-Kriesche HU, Mannon RB, Dumortier T, Aggarwal V, Podichetty JT, O'Doherty I, Gaber AO, Fitzsimmons WE; Transplant Therapeutics Consortium. Klein A, et al. Among authors: o doherty i. Am J Transplant. 2023 Oct;23(10):1496-1506. doi: 10.1016/j.ajt.2023.04.018. Epub 2023 Sep 18. Am J Transplant. 2023. PMID: 37735044
Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes.
Klein A, Loupy A, Stegall M, Helanterä I, Kosinski L, Frey E, Aubert O, Divard G, Newell K, Meier-Kriesche HU, Mannon R, Dumortier T, Aggarwal V, Podichetty JT, O'Doherty I, Gaber AO, Fitzsimmons WE. Klein A, et al. Among authors: o doherty i. Transpl Int. 2023 Sep 25;36:11951. doi: 10.3389/ti.2023.11951. eCollection 2023. Transpl Int. 2023. PMID: 37822449 Free PMC article.
18 results