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Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.
Mehrotra N, Bhattaram A, Earp JC, Florian J, Krudys K, Lee JE, Lee JY, Liu J, Mulugeta Y, Yu J, Zhao P, Sinha V. Mehrotra N, et al. Among authors: florian j. Drug Metab Dispos. 2016 Jul;44(7):924-33. doi: 10.1124/dmd.116.069559. Epub 2016 Apr 14. Drug Metab Dispos. 2016. PMID: 27079249 Review.
U.S. Food and drug administration approval: obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia.
Lee HZ, Miller BW, Kwitkowski VE, Ricci S, DelValle P, Saber H, Grillo J, Bullock J, Florian J, Mehrotra N, Ko CW, Nie L, Shapiro M, Tolnay M, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. Lee HZ, et al. Among authors: florian j. Clin Cancer Res. 2014 Aug 1;20(15):3902-7. doi: 10.1158/1078-0432.CCR-14-0516. Epub 2014 May 13. Clin Cancer Res. 2014. PMID: 24824310 Clinical Trial.
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: florian j. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
245 results