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Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.
Conrado DJ, Larkindale J, Berg A, Hill M, Burton J, Abrams KR, Abresch RT, Bronson A, Chapman D, Crowther M, Duong T, Gordish-Dressman H, Harnisch L, Henricson E, Kim S, McDonald CM, Schmidt S, Vong C, Wang X, Wong BL, Yong F, Romero K; Duchenne Muscular Dystrophy Regulatory Science Consortium (D-RSC). Conrado DJ, et al. Among authors: schmidt s. J Pharmacokinet Pharmacodyn. 2019 Oct;46(5):441-455. doi: 10.1007/s10928-019-09642-7. Epub 2019 May 24. J Pharmacokinet Pharmacodyn. 2019. PMID: 31127458
Machine Learning in Drug Discovery and Development Part 1: A Primer.
Talevi A, Morales JF, Hather G, Podichetty JT, Kim S, Bloomingdale PC, Kim S, Burton J, Brown JD, Winterstein AG, Schmidt S, White JK, Conrado DJ. Talevi A, et al. Among authors: schmidt s. CPT Pharmacometrics Syst Pharmacol. 2020 Mar;9(3):129-142. doi: 10.1002/psp4.12491. Epub 2020 Mar 11. CPT Pharmacometrics Syst Pharmacol. 2020. PMID: 31905263 Free PMC article.
Development of a model-based clinical trial simulation platform to optimize the design of clinical trials for Duchenne muscular dystrophy.
Lingineni K, Aggarwal V, Morales JF, Conrado DJ, Corey D, Vong C, Burton J, Larkindale J, Romero K, Schmidt S, Kim S; Cooperative International Neuromuscular Research Group investigators and Duchenne Regulatory Science Consortium members. Lingineni K, et al. Among authors: schmidt s. CPT Pharmacometrics Syst Pharmacol. 2022 Mar;11(3):318-332. doi: 10.1002/psp4.12753. Epub 2022 Jan 3. CPT Pharmacometrics Syst Pharmacol. 2022. PMID: 34877803 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: schmidt s. 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.
Type 1 diabetes prevention clinical trial simulator: Case reports of model-informed drug development tool.
Morales JF, Klose M, Hoffert Y, Podichetty JT, Burton J, Schmidt S, Romero K, O'Doherty I, Martin F, Campbell-Thompson M, Haller MJ, Atkinson MA, Kim S. Morales JF, et al. Among authors: schmidt s. CPT Pharmacometrics Syst Pharmacol. 2024 Aug;13(8):1309-1316. doi: 10.1002/psp4.13193. Epub 2024 Jul 3. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 38961520 Free PMC article.
5,522 results