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Year Number of Results
2013 1
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2016 4
2017 3
2018 1
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2020 3
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2023 3
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Page 1
Paediatric extrapolation: A necessary paradigm shift.
Ollivier C, Mulugeta YL, Ruggieri L, Saint-Raymond A, Yao L. Ollivier C, et al. Among authors: mulugeta yl. Br J Clin Pharmacol. 2019 Apr;85(4):675-679. doi: 10.1111/bcp.13809. Epub 2018 Dec 18. Br J Clin Pharmacol. 2019. PMID: 30403304 Free PMC article. Review.
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.
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.
Evaluation of FDA Labeling Changes Related to PREA Safety-Waivers.
Krastein J, Pica-Branco D, Bacho MA, Mulugeta Y, Maynard JW, Alexander JJ, Yao L, Hausman ED. Krastein J, et al. Among authors: mulugeta y. Ther Innov Regul Sci. 2023 Sep;57(5):1099-1103. doi: 10.1007/s43441-023-00551-z. Epub 2023 Jun 30. Ther Innov Regul Sci. 2023. PMID: 37389793
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.
Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop.
Barrett JS, Bucci-Rechtweg C, Amy Cheung SY, Gamalo-Siebers M, Haertter S, Karres J, Marquard J, Mulugeta Y, Ollivier C, Strougo A, Yanoff L, Yao L, Zeitler P. Barrett JS, et al. Among authors: mulugeta y. Clin Pharmacol Ther. 2020 Jul;108(1):29-39. doi: 10.1002/cpt.1805. Epub 2020 Mar 16. Clin Pharmacol Ther. 2020. PMID: 32017043 Free PMC article.
17 results