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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.
Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms.
Guth BD, Engwall M, Eldridge S, Foley CM, Guo L, Gintant G, Koerner J, Parish ST, Pierson JB, Ribeiro AJS, Zabka T, Chaudhary KW, Kanda Y, Berridge B. Guth BD, et al. Front Pharmacol. 2019 Aug 9;10:884. doi: 10.3389/fphar.2019.00884. eCollection 2019. Front Pharmacol. 2019. PMID: 31447679 Free PMC article. 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.
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.
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
An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation.
Authier S, Abernathy MM, Correll K, Chui RW, Dalton J, Foley CM, Friedrichs GS, Koerner JE, Kallman MJ, Pannirselvam M, Redfern WS, Urmaliya V, Valentin JP, Wisialowski T, Zabka TS, Pugsley MK. Authier S, et al. Among authors: zabka ts. Int J Toxicol. 2020 Jul/Aug;39(4):274-293. doi: 10.1177/1091581820921338. Epub 2020 May 14. Int J Toxicol. 2020. PMID: 32406289
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.
50 results