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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: krudys k. 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: krudys k. Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000. Clin Pharmacokinet. 2011. PMID: 21895036
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: krudys k. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.
Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N. Darpo B, et al. Among authors: krudys k. Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60. Clin Pharmacol Ther. 2015. PMID: 25670536 Clinical Trial.
19 results