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Page 1
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. 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.
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. 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
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. 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 unified clinical trial database for Alzheimer's disease.
Neville J, Kopko S, Broadbent S, Avilés E, Stafford R, Solinsky CM, Bain LJ, Cisneroz M, Romero K, Stephenson D; Coalition Against Major Diseases. Neville J, et al. Among authors: romero k. Alzheimers Dement. 2015 Oct;11(10):1212-21. doi: 10.1016/j.jalz.2014.11.005. Epub 2015 Feb 9. Alzheimers Dement. 2015. PMID: 25676387
Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease.
Stephenson D, Hu MT, Romero K, Breen K, Burn D, Ben-Shlomo Y, Bhattaram A, Isaac M, Venuto C, Kubota K, Little MA, Friend S, Lovestone S, Morris HR, Grosset D, Sutherland M, Gallacher J, Williams-Gray C, Bain LJ, Avilés E, Marek K, Toga AW, Stark Y, Forrest Gordon M, Ford S. Stephenson D, et al. Among authors: romero k. J Parkinsons Dis. 2015;5(3):581-94. doi: 10.3233/JPD-150570. J Parkinsons Dis. 2015. PMID: 26406139 Free PMC article.
Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.
Arnerić SP, Batrla-Utermann R, Beckett L, Bittner T, Blennow K, Carter L, Dean R, Engelborghs S, Genius J, Gordon MF, Hitchcock J, Kaplow J, Luthman J, Meibach R, Raunig D, Romero K, Samtani MN, Savage M, Shaw L, Stephenson D, Umek RM, Vanderstichele H, Willis B, Yule S. Arnerić SP, et al. Among authors: romero k. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
Open innovation: Towards sharing of data, models and workflows.
Conrado DJ, Karlsson MO, Romero K, Sarr C, Wilkins JJ. Conrado DJ, et al. Among authors: romero k. Eur J Pharm Sci. 2017 Nov 15;109S:S65-S71. doi: 10.1016/j.ejps.2017.06.035. Epub 2017 Jul 4. Eur J Pharm Sci. 2017. PMID: 28684136 Review.
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: romero k. 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.
Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Arnerić SP, Cedarbaum JM, Khozin S, Papapetropoulos S, Hill DL, Ropacki M, Rhodes J, Dacks PA, Hudson LD, Gordon MF, Kern VD, Romero K, Vradenburg G, Au R, Karlin DR, Facheris MF, Fitzer-Attas CJ, Vitolo OV, Wang J, Miller BM, Kaye JA. Arnerić SP, et al. Among authors: romero k. Nat Rev Drug Discov. 2017 Oct;16(10):736. doi: 10.1038/nrd.2017.153. Epub 2017 Sep 22. Nat Rev Drug Discov. 2017. PMID: 28935908 No abstract available.
236 results