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Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop.
Bai JP, Bell R, Buckman S, Burckart GJ, Eichler HG, Fang KC, Goodsaid FM, Jusko WJ, Lesko LL, Meibohm B, Patterson SD, Puig O, Smerage JB, Snider BJ, Wagner JA, Wang J, Walton MK, Weiner R. Bai JP, et al. Among authors: burckart gj. AAPS J. 2011 Jun;13(2):274-83. doi: 10.1208/s12248-011-9265-x. Epub 2011 Mar 30. AAPS J. 2011. PMID: 21448748 Free PMC article.
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
Mulugeta Y, Barrett JS, Nelson R, Eshete AT, Mushtaq A, Yao L, Glasgow N, Mulberg AE, Gonzalez D, Green D, Florian J, Krudys K, Seo S, Kim I, Chilukuri D, Burckart GJ. Mulugeta Y, et al. Among authors: burckart gj. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
Dosing Recommendations for Pediatric Patients With Renal Impairment.
Al-Khouja A, Park K, Anderson DJC, Young C, Wang J, Huang SM, Khurana M, Burckart GJ. Al-Khouja A, et al. Among authors: burckart gj. J Clin Pharmacol. 2020 Dec;60(12):1551-1560. doi: 10.1002/jcph.1676. Epub 2020 Jun 15. J Clin Pharmacol. 2020. PMID: 32542790 Free PMC article.
Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications.
Zhang Y, Zhang L, Abraham S, Apparaju S, Wu TC, Strong JM, Xiao S, Atkinson AJ Jr, Thummel KE, Leeder JS, Lee C, Burckart GJ, Lesko LJ, Huang SM. Zhang Y, et al. Among authors: burckart gj. Clin Pharmacol Ther. 2009 Mar;85(3):305-11. doi: 10.1038/clpt.2008.208. Epub 2008 Nov 19. Clin Pharmacol Ther. 2009. PMID: 19020495
Pediatric dose selection.
Abernethy DR, Burckart GJ. Abernethy DR, et al. Among authors: burckart gj. Clin Pharmacol Ther. 2010 Mar;87(3):270-1. doi: 10.1038/clpt.2009.292. Clin Pharmacol Ther. 2010. PMID: 20160747 Review.
285 results