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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. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument.
McCarrier KP, Atkinson TM, DeBusk KP, Liepa AM, Scanlon M, Coons SJ; Patient-Reported Outcome Consortium, Non–Small Cell Lung Cancer Working Group. McCarrier KP, et al. Clin Ther. 2016 Apr;38(4):794-810. doi: 10.1016/j.clinthera.2016.03.012. Epub 2016 Apr 1. Clin Ther. 2016. PMID: 27041408 Free PMC article.
Serum Natriuretic Peptides as Differential Biomarkers Allowing for the Distinction between Physiologic and Pathologic Left Ventricular Hypertrophy.
Dunn ME, Manfredi TG, Agostinucci K, Engle SK, Powe J, King NM, Rodriguez LA, Gropp KE, Gallacher M, Vetter FJ, More V, Shimpi P, Serra D, Colton HM; Cardiac Hypertrophy Working Group of the Predictive Safety Testing Consortium. Dunn ME, et al. Toxicol Pathol. 2017 Feb;45(2):344-352. doi: 10.1177/0192623316634231. Epub 2016 Jul 11. Toxicol Pathol. 2017. PMID: 27102652
Operationalizing hippocampal volume as an enrichment biomarker for amnestic mild cognitive impairment trials: effect of algorithm, test-retest variability, and cut point on trial cost, duration, and sample size.
Yu P, Sun J, Wolz R, Stephenson D, Brewer J, Fox NC, Cole PE, Jack CR Jr, Hill DL, Schwarz AJ; Coalition Against Major Diseases and the Alzheimer's Disease Neuroimaging Initiative. Yu P, et al. Neurobiol Aging. 2014 Apr;35(4):808-18. doi: 10.1016/j.neurobiolaging.2013.09.039. Epub 2013 Oct 3. Neurobiol Aging. 2014. PMID: 24211008 Free PMC article.