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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: gordon mf. 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. Among authors: gordon mf. 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: gordon mf. 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: gordon mf. 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.
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: gordon mf. 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.
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. Among authors: gordon mf. 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: gordon mf. 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
104 results