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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: mulugeta y. 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.
Failed Pediatric Drug Development Trials.
Momper JD, Mulugeta Y, Burckart GJ. Momper JD, et al. Among authors: mulugeta y. Clin Pharmacol Ther. 2015 Sep;98(3):245-51. doi: 10.1002/cpt.142. Epub 2015 Jun 26. Clin Pharmacol Ther. 2015. PMID: 25963725
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. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.
Zimmerman K, Putera M, Hornik CP, Brian Smith P, Benjamin DK Jr, Mulugeta Y, Burckart GJ, Cohen-Wolkowiez M, Gonzalez D. Zimmerman K, et al. Among authors: mulugeta y. Clin Ther. 2016 Sep;38(9):1995-2005. doi: 10.1016/j.clinthera.2016.06.003. Epub 2016 Jun 28. Clin Ther. 2016. PMID: 27364807 Free PMC article. Review.
37 results