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What evidence do we need for biomarker qualification?
Leptak C, Menetski JP, Wagner JA, Aubrecht J, Brady L, Brumfield M, Chin WW, Hoffmann S, Kelloff G, Lavezzari G, Ranganathan R, Sauer JM, Sistare FD, Zabka T, Wholley D. Leptak C, et al. Among authors: zabka t. Sci Transl Med. 2017 Nov 22;9(417):eaal4599. doi: 10.1126/scitranslmed.aal4599. Sci Transl Med. 2017. PMID: 29167393 Review.
Nonclinical safety biomarkers of drug-induced vascular injury: current status and blueprint for the future.
Mikaelian I, Cameron M, Dalmas DA, Enerson BE, Gonzalez RJ, Guionaud S, Hoffmann PK, King NM, Lawton MP, Scicchitano MS, Smith HW, Thomas RA, Weaver JL, Zabka TS; Vascular Injury Working Group of the Predictive Safety Consortium. Mikaelian I, et al. Toxicol Pathol. 2014 Jun;42(4):635-57. doi: 10.1177/0192623314525686. Epub 2014 Apr 28. Toxicol Pathol. 2014. PMID: 24777748
Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week.
Januzzi JL Jr, Canty JM, Das S, DeFilippi CR, Gintant GA, Gutstein DE, Jaffe A, Kaushik EP, Leptak C, Mehta C, Pina I, Povsic TJ, Rambaran C, Rhyne RF, Salas M, Shi VC, Udell JA, Unger EF, Zabka TS, Seltzer JH. Januzzi JL Jr, et al. Among authors: zabka ts. J Am Coll Cardiol. 2021 Apr 20;77(15):1922-1933. doi: 10.1016/j.jacc.2021.02.040. J Am Coll Cardiol. 2021. PMID: 33858628 Free article. Review.
The use of emerging safety biomarkers in nonclinical and clinical safety assessment - The current and future state: An IQ DruSafe industry survey.
Zabka TS, Burkhardt J, Reagan WJ, Gautier JC, Glaab WE, Guffroy M, Harding J, Brees D, McDuffie E, Ramaiah L, Schultze AE, Smith JD, Wolfreys A, Dalmas DA. Zabka TS, et al. Regul Toxicol Pharmacol. 2021 Mar;120:104857. doi: 10.1016/j.yrtph.2020.104857. Epub 2020 Dec 31. Regul Toxicol Pharmacol. 2021. PMID: 33387566 Free article.
Preclinical models of nicotinamide phosphoribosyltransferase inhibitor-mediated hematotoxicity and mitigation by co-treatment with nicotinic acid.
Tarrant JM, Dhawan P, Singh J, Zabka TS, Clarke E, DosSantos G, Dragovich PS, Sampath D, Lin T, McCray B, La N, Nguyen T, Kauss A, Dambach D, Misner DL, Diaz D, Uppal H. Tarrant JM, et al. Among authors: zabka ts. Toxicol Mech Methods. 2015 Mar;25(3):201-11. doi: 10.3109/15376516.2015.1014080. Epub 2015 Apr 20. Toxicol Mech Methods. 2015. PMID: 25894564
Establishment of baseline profiles of 50 bile acids in preclinical toxicity species: A comprehensive assessment of translational differences and study design considerations for biomarker development.
Sangaraju D, Katavolos P, Liang X, Chou C, Zabka TS, Dean B, Maher J. Sangaraju D, et al. Among authors: zabka ts. Toxicol Appl Pharmacol. 2022 May 15;443:116008. doi: 10.1016/j.taap.2022.116008. Epub 2022 Apr 1. Toxicol Appl Pharmacol. 2022. PMID: 35378153
51 results