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Year Number of Results
2016 3
2017 10
2018 11
2019 15
2020 13
2021 8
2022 2
2024 0

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49 results

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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. 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.
Volumetric MRI-Based Biomarkers in Huntington's Disease: An Evidentiary Review.
Kinnunen KM, Schwarz AJ, Turner EC, Pustina D, Gantman EC, Gordon MF, Joules R, Mullin AP, Scahill RI, Georgiou-Karistianis N; Huntington's Disease Regulatory Science Consortium (HD-RSC). Kinnunen KM, et al. Front Neurol. 2021 Sep 21;12:712555. doi: 10.3389/fneur.2021.712555. eCollection 2021. Front Neurol. 2021. PMID: 34621236 Free PMC article. Review.
A Disease Progression Model to Quantify the Nonmotor Symptoms of Parkinson's Disease in Participants With Leucine-Rich Repeat Kinase 2 Mutation.
Ahamadi M, Mehrotra N, Hanan N, Lai Yee K, Gheyas F, Anton J, Bani M, Boroojerdi B, Smit H, Weidemann J, Macha S, Thuillier V, Chen C, Yang M, Williams-Gray CH, Stebbins GT, Pagano G, Hang Y, Marek K, Venuto CS, Javidnia M, Dexter D, Pedata A, Stafford B, Akalu M, Stephenson D, Romero K, Sinha V; Critical Path for Parkinson’s Consortium. Ahamadi M, et al. Clin Pharmacol Ther. 2021 Aug;110(2):508-518. doi: 10.1002/cpt.2277. Epub 2021 Jun 12. Clin Pharmacol Ther. 2021. PMID: 33894056
Qualification of translational safety biomarkers.
Sauer JM, Porter AC. Sauer JM, et al. Exp Biol Med (Maywood). 2021 Nov;246(22):2391-2398. doi: 10.1177/15353702211002153. Epub 2021 Mar 23. Exp Biol Med (Maywood). 2021. PMID: 33757340 Free PMC article. Review.
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.
Stephenson D, Alexander R, Aggarwal V, Badawy R, Bain L, Bhatnagar R, Bloem BR, Boroojerdi B, Burton J, Cedarbaum JM, Cosman J, Dexter DT, Dockendorf M, Dorsey ER, Dowling AV, Evers LJW, Fisher K, Frasier M, Garcia-Gancedo L, Goldsack JC, Hill D, Hitchcock J, Hu MT, Lawton MP, Lee SJ, Lindemann M, Marek K, Mehrotra N, Meinders MJ, Minchik M, Oliva L, Romero K, Roussos G, Rubens R, Sadar S, Scheeren J, Sengoku E, Simuni T, Stebbins G, Taylor KI, Yang B, Zach N. Stephenson D, et al. Digit Biomark. 2020 Nov 26;4(Suppl 1):28-49. doi: 10.1159/000512500. eCollection 2020 Winter. Digit Biomark. 2020. PMID: 33442579 Free PMC article. Review.
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. 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.
49 results