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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: webb c. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
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. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
Probing Neurophysiological Processes Related to Self-Referential Processing to Predict Improvement for Depressed Adolescents Receiving Cognitive Behavioral Therapy.
Kim N, Bloom PA, Rosellini AJ, Webb CA, Pizzagalli DA, Auerbach RP. Kim N, et al. Among authors: webb ca. Biol Psychiatry Cogn Neurosci Neuroimaging. 2024 Nov 2:S2451-9022(24)00309-4. doi: 10.1016/j.bpsc.2024.10.010. Online ahead of print. Biol Psychiatry Cogn Neurosci Neuroimaging. 2024. PMID: 39491787
Engaging Burn Survivors, Their Families, and the Burn Community in Patient-Centered Outcomes Research: A Burn Survivor- and Burn Community Stakeholder-Generated and Prioritized Research Agenda.
Thompson CM, Acton A, Alexander W, Beyene R, Brownson EG, Carrougher GJ, Christensen B, Hoarle K, Irven J, Johnson LS, Kirkham MP, Lewis GM, Lucio JX, Matagi S, Morris L, Prazak AMB, Price-Smith E, Stuchly B, Webb C, Quinn K; Burn Survivor-Centered Outcomes Research (BSCOR) Collaborative. Thompson CM, et al. Among authors: webb c. J Burn Care Res. 2024 Oct 25:irae196. doi: 10.1093/jbcr/irae196. Online ahead of print. J Burn Care Res. 2024. PMID: 39451070
1,656 results