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Safety biomarker applications in drug development.
Schomaker S, Ramaiah S, Khan N, Burkhardt J. Schomaker S, et al. J Toxicol Sci. 2019;44(4):225-235. doi: 10.2131/jts.44.225. J Toxicol Sci. 2019. PMID: 30944276 Free article. Review.
Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop.
Palazzi X, Burkhardt JE, Caplain H, Dellarco V, Fant P, Foster JR, Francke S, Germann P, Gröters S, Harada T, Harleman J, Inui K, Kaufmann W, Lenz B, Nagai H, Pohlmeyer-Esch G, Schulte A, Skydsgaard M, Tomlinson L, Wood CE, Yoshida M. Palazzi X, et al. Among authors: burkhardt je. Toxicol Pathol. 2016 Aug;44(6):810-24. doi: 10.1177/0192623316642527. Epub 2016 Apr 21. Toxicol Pathol. 2016. PMID: 27102650
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.
Practical aspects of discovery pathology.
Burkhardt JE, Ryan AM, Germann PG. Burkhardt JE, et al. Toxicol Pathol. 2002 Jan-Feb;30(1):8-10. doi: 10.1080/01926230252824653. Toxicol Pathol. 2002. PMID: 11890479 Review.
37 results