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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. Among authors: zabka ts. Toxicol Pathol. 2014 Jun;42(4):635-57. doi: 10.1177/0192623314525686. Epub 2014 Apr 28. Toxicol Pathol. 2014. PMID: 24777748
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.
Engelhardt JA, Fant P, Guionaud S, Henry SP, Leach MW, Louden C, Scicchitano MS, Weaver JL, Zabka TS, Frazier KS; Society of Toxicologic Pathology Vascular Injury Working Group. Engelhardt JA, et al. Among authors: zabka ts. Toxicol Pathol. 2015 Oct;43(7):935-44. doi: 10.1177/0192623315570341. Epub 2015 Feb 24. Toxicol Pathol. 2015. PMID: 25717082 Review.
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics.
Frazier KS, Engelhardt JA, Fant P, Guionaud S, Henry SP, Leach MW, Louden C, Scicchitano MS, Weaver JL, Zabka TS; Society of Toxicologic Pathology Vascular Injury Working Group. Frazier KS, et al. Among authors: zabka ts. Toxicol Pathol. 2015 Oct;43(7):915-34. doi: 10.1177/0192623315570340. Epub 2015 Feb 26. Toxicol Pathol. 2015. PMID: 25722122 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.
Evaluation of the Relative Performance of Drug-Induced Skeletal Muscle Injury Biomarkers in Rats.
Burch PM, Greg Hall D, Walker EG, Bracken W, Giovanelli R, Goldstein R, Higgs RE, King NM, Lane P, Sauer JM, Michna L, Muniappa N, Pritt ML, Vlasakova K, Watson DE, Wescott D, Zabka TS, Glaab WE. Burch PM, et al. Among authors: zabka ts. Toxicol Sci. 2016 Mar;150(1):247-56. doi: 10.1093/toxsci/kfv328. Epub 2015 Dec 31. Toxicol Sci. 2016. PMID: 26721300
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. Sci Transl Med. 2017 Nov 22;9(417):eaal4599. doi: 10.1126/scitranslmed.aal4599. Sci Transl Med. 2017. PMID: 29167393 Review.
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