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Response to "Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments".
Ropacki MT, Hannesdottir K, Hendrix S, Gordon MF, Stephenson D, Coons SJ, Stern RA; Critical Path Institute’s Coalition Against Major Diseases and Patient-Reported Outcome Consortium Cognition Working Group. Ropacki MT, et al. Among authors: stephenson d. Ther Innov Regul Sci. 2018 Jul;52(4):405-406. doi: 10.1177/2168479018771309. Ther Innov Regul Sci. 2018. PMID: 29996731 No abstract available.
Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases.
Stephenson D, Aviles E, Bain LJ, Brumfield M, Carrillo M, Comery TA, Compton C, Corrigan B, Gordon MF, Jack CR Jr, Katz R, Logovinsky V, Satlin A, Marek K, Nicholas T, Polhamus D, Angersbach BS, Raghavan N, Romano G, Romero K, Shaw L, Woodcock J, Vradenburg G, Isaac M. Stephenson D, et al. Ther Innov Regul Sci. 2013 Nov;47(6):632-638. doi: 10.1177/2168479013498386. Ther Innov Regul Sci. 2013. PMID: 30235546
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: stephenson d. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
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: stephenson d. 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.
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.
Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado DJ, Dexter DT, Seibyl J, Jennings D, Nicholas T, Matthews D, Xie Z, Imam S, Maguire P, Russell D, Gordon MF, Stebbins GT, Somer E, Gallagher J, Roach A, Basseches P, Grosset D, Marek K; Critical Path for Parkinson’s Consortium. Stephenson D, et al. J Parkinsons Dis. 2019;9(3):553-563. doi: 10.3233/JPD-191648. J Parkinsons Dis. 2019. PMID: 31306141 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: stephenson d. 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
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: stephenson d. 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 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: stephenson d. 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.
553 results