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The future is now: model-based clinical trial design for Alzheimer's disease.
Romero K, Ito K, Rogers JA, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, Brown D, Isaac M, Vamvakas S, Hemmings R, Pani L, Bain LJ, Corrigan B; Alzheimer's Disease Neuroimaging Initiative; Coalition Against Major Diseases. Romero K, et al. Among authors: sinha v. Clin Pharmacol Ther. 2015 Mar;97(3):210-4. doi: 10.1002/cpt.16. Epub 2014 Dec 27. Clin Pharmacol Ther. 2015. PMID: 25669145 Free PMC article.
Development of a Disease Progression Model for Leucine-Rich Repeat Kinase 2 in Parkinson's Disease to Inform Clinical Trial Designs.
Ahamadi M, Conrado DJ, Macha S, Sinha V, Stone J, Burton J, Nicholas T, Gallagher J, Dexter D, Bani M, Boroojerdi B, Smit H, Weidemann J, Chen C, Yang M, Maciuca R, Lawson R, Burn D, Marek K, Venuto C, Stafford B, Akalu M, Stephenson D, Romero K; Critical Path for Parkinson's (CPP) Consortium. Ahamadi M, et al. Among authors: sinha v. Clin Pharmacol Ther. 2020 Mar;107(3):553-562. doi: 10.1002/cpt.1634. Epub 2019 Dec 5. Clin Pharmacol Ther. 2020. PMID: 31544231 Free PMC article.
Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.
Romero K, Sinha V, Allerheiligen S, Danhof M, Pinheiro J, Kruhlak N, Wang Y, Wang SJ, Sauer JM, Marier JF, Corrigan B, Rogers J, Lambers Heerspink HJ, Gumbo T, Vis P, Watkins P, Morrison T, Gillespie W, Gordon MF, Stephenson D, Hanna D, Pfister M, Lalonde R, Colatsky T. Romero K, et al. Among authors: sinha v. J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):545-52. doi: 10.1007/s10928-014-9390-0. Epub 2014 Oct 7. J Pharmacokinet Pharmacodyn. 2014. PMID: 25288257
Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease.
Romero K, Conrado D, Burton J, Nicholas T, Sinha V, Macha S, Ahamadi M, Cedarbaum J, Seibyl J, Marek K, Basseches P, Hill D, Somer E, Gallagher J, Dexter DT, Roach A, Stephenson D; Critical Path for Parkinson's (CPP) Consortium; Parkinson's Progression Markers Initiative (PPMI). Romero K, et al. Among authors: sinha v. Clin Transl Sci. 2019 May;12(3):240-246. doi: 10.1111/cts.12619. Epub 2019 Mar 18. Clin Transl Sci. 2019. PMID: 30706986 Free PMC article.
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. Among authors: sinha v. Clin Pharmacol Ther. 2021 Aug;110(2):508-518. doi: 10.1002/cpt.2277. Epub 2021 Jun 12. Clin Pharmacol Ther. 2021. PMID: 33894056
Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis.
Conrado DJ, Nicholas T, Tsai K, Macha S, Sinha V, Stone J, Corrigan B, Bani M, Muglia P, Watson IA, Kern VD, Sheveleva E, Marek K, Stephenson DT, Romero K; Critical Path for Parkinson's (CPP) Parkinson's Disease Modeling and Simulation Working Group. Conrado DJ, et al. Among authors: sinha v. Clin Transl Sci. 2018 Jan;11(1):63-70. doi: 10.1111/cts.12492. Epub 2017 Jul 27. Clin Transl Sci. 2018. PMID: 28749580 Free PMC article.
Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders.
Mulberg AE, Bucci-Rechtweg C, Giuliano J, Jacoby D, Johnson FK, Liu Q, Marsden D, McGoohan S, Nelson R, Patel N, Romero K, Sinha V, Sitaraman S, Spaltro J, Kessler V. Mulberg AE, et al. Among authors: sinha v. Orphanet J Rare Dis. 2019 Feb 8;14(1):36. doi: 10.1186/s13023-019-1017-5. Orphanet J Rare Dis. 2019. PMID: 30736861 Free PMC article.
723 results