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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: earp jc. 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.
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, Jadhav PR, Krudys K, Lesko LJ, Li F, Liu J, Madabushi R, Marathe A, Mehrotra N, Tornoe C, Wang Y, Zhu H. Lee JY, et al. Among authors: earp jc. Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000. Clin Pharmacokinet. 2011. PMID: 21895036
Model-Informed Drug Development in Pediatric Dose Selection.
Bi Y, Liu J, Li F, Yu J, Bhattaram A, Bewernitz M, Li RJ, Ahn J, Earp J, Ma L, Zhuang L, Yang Y, Zhang X, Zhu H, Wang Y. Bi Y, et al. J Clin Pharmacol. 2021 Jun;61 Suppl 1:S60-S69. doi: 10.1002/jcph.1848. J Clin Pharmacol. 2021. PMID: 34185906 Review.
Anti-SARS-CoV-2 Repurposing Drug Database: Clinical Pharmacology Considerations.
Zhang X, Yang Y, Grimstein M, Liu G, Kitabi E, Fan J, Wang YH, Earp J, Weaver JL, Zhu H, Liu J, Reynolds KS, Huang SM, Wang Y. Zhang X, et al. CPT Pharmacometrics Syst Pharmacol. 2021 Sep;10(9):973-982. doi: 10.1002/psp4.12681. Epub 2021 Aug 1. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34218521 Free PMC article. Review.
40 results