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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.
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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