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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.
Big data to smart data in Alzheimer's disease: The brain health modeling initiative to foster actionable knowledge.
Geerts H, Dacks PA, Devanarayan V, Haas M, Khachaturian ZS, Gordon MF, Maudsley S, Romero K, Stephenson D; Brain Health Modeling Initiative (BHMI). Geerts H, et al. Among authors: romero k. Alzheimers Dement. 2016 Sep;12(9):1014-1021. doi: 10.1016/j.jalz.2016.04.008. Epub 2016 May 26. Alzheimers Dement. 2016. PMID: 27238630 Free article. Review.
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.
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.
223 results