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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: larkindale j. 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
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: larkindale j. 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.
Duchenne Regulatory Science Consortium Meeting on Disease Progression Modeling for Duchenne Muscular Dystrophy.
Larkindale J, Abresch R, Aviles E, Bronson A, Chin J, Furlong P, Gordish-Dressman H, Habeeb-Louks E, Henricson E, Kroger H, Lynn C, Lynn S, Martin D, Nuckolls G, Rooney W, Romero K, Sweeney L, Vandenborne K, Walter G, Wolff J, Wong B, McDonald CM, Duchenne Regulatory Science Consortium Imaging-Dmd Consortium And The Cinrg Investigators MO. Larkindale J, et al. PLoS Curr. 2017 Jan 12;9:ecurrents.md.83071bbd728982f2f1073f4950e03586. doi: 10.1371/currents.md.83071bbd728982f2f1073f4950e03586. PLoS Curr. 2017. PMID: 28228973 Free PMC 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: larkindale j. 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 TREAT-NMD advisory committee for therapeutics (TACT): an innovative de-risking model to foster orphan drug development.
Heslop E, Csimma C, Straub V, McCall J, Nagaraju K, Wagner KR, Caizergues D, Korinthenberg R, Flanigan KM, Kaufmann P, McNeil E, Mendell J, Hesterlee S, Wells DJ, Bushby K; TACT. Heslop E, et al. Orphanet J Rare Dis. 2015 Apr 23;10:49. doi: 10.1186/s13023-015-0258-1. Orphanet J Rare Dis. 2015. PMID: 25902795 Free PMC article. Review.
Cost of illness for neuromuscular diseases in the United States.
Larkindale J, Yang W, Hogan PF, Simon CJ, Zhang Y, Jain A, Habeeb-Louks EM, Kennedy A, Cwik VA. Larkindale J, et al. Muscle Nerve. 2014 Mar;49(3):431-8. doi: 10.1002/mus.23942. Epub 2014 Jan 28. Muscle Nerve. 2014. PMID: 23836444
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