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Page 1
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W. Dieterle F, et al. Among authors: vamvakas s. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
Towards consensus practices to qualify safety biomarkers for use in early drug development.
Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y. Sistare FD, et al. Among authors: vamvakas s. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.
Isaac M, Vamvakas S, Abadie E, Jonsson B, Gispen C, Pani L. Isaac M, et al. Among authors: vamvakas s. Eur Neuropsychopharmacol. 2011 Nov;21(11):781-8. doi: 10.1016/j.euroneuro.2011.08.003. Epub 2011 Sep 7. Eur Neuropsychopharmacol. 2011. PMID: 21903360
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
Hill DLG, Schwarz AJ, Isaac M, Pani L, Vamvakas S, Hemmings R, Carrillo MC, Yu P, Sun J, Beckett L, Boccardi M, Brewer J, Brumfield M, Cantillon M, Cole PE, Fox N, Frisoni GB, Jack C, Kelleher T, Luo F, Novak G, Maguire P, Meibach R, Patterson P, Bain L, Sampaio C, Raunig D, Soares H, Suhy J, Wang H, Wolz R, Stephenson D. Hill DLG, et al. Among authors: vamvakas s. Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003. Alzheimers Dement. 2014. PMID: 24985687
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: vamvakas s. 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.
145 results