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179 results

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U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.
Deisseroth A, Kaminskas E, Grillo J, Chen W, Saber H, Lu HL, Rothmann MD, Brar S, Wang J, Garnett C, Bullock J, Burke LB, Rahman A, Sridhara R, Farrell A, Pazdur R. Deisseroth A, et al. Among authors: garnett c. Clin Cancer Res. 2012 Jun 15;18(12):3212-7. doi: 10.1158/1078-0432.CCR-12-0653. Epub 2012 Apr 27. Clin Cancer Res. 2012. PMID: 22544377
Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.
Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y, Zheng JJ. Bhattaram VA, et al. Among authors: garnett c. Clin Pharmacol Ther. 2007 Feb;81(2):213-21. doi: 10.1038/sj.clpt.6100051. Clin Pharmacol Ther. 2007. PMID: 17259946
Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.
Hazarika M, Jiang X, Liu Q, Lee SL, Ramchandani R, Garnett C, Orr MS, Sridhara R, Booth B, Leighton JK, Timmer W, Harapanhalli R, Dagher R, Justice R, Pazdur R. Hazarika M, et al. Among authors: garnett c. Clin Cancer Res. 2008 Sep 1;14(17):5325-31. doi: 10.1158/1078-0432.CCR-08-0308. Clin Cancer Res. 2008. PMID: 18765523
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: garnett ce. Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000. Clin Pharmacokinet. 2011. PMID: 21895036
Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.
Thornton K, Kim G, Maher VE, Chattopadhyay S, Tang S, Moon YJ, Song P, Marathe A, Balakrishnan S, Zhu H, Garnett C, Liu Q, Booth B, Gehrke B, Dorsam R, Verbois L, Ghosh D, Wilson W, Duan J, Sarker H, Miksinski SP, Skarupa L, Ibrahim A, Justice R, Murgo A, Pazdur R. Thornton K, et al. Among authors: garnett c. Clin Cancer Res. 2012 Jul 15;18(14):3722-30. doi: 10.1158/1078-0432.CCR-12-0411. Epub 2012 Jun 4. Clin Cancer Res. 2012. PMID: 22665903 Clinical Trial.
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.
Fleming TR, Garnett CE, Conklin LS, Corriol-Rohou S, Hariharan S, Hsu D, Mueller-Velten G, Mulugeta Y, Portman R, Rothmann MD, Stockbridge NL, Wandel S, Zhang J, Yao L. Fleming TR, et al. Ther Innov Regul Sci. 2023 Jan;57(1):109-120. doi: 10.1007/s43441-022-00445-6. Epub 2022 Sep 3. Ther Innov Regul Sci. 2023. PMID: 36057747 Free PMC article.
Creation of a knowledge management system for QT analyses.
Tornøe CW, Garnett CE, Wang Y, Florian J, Li M, Gobburu JV. Tornøe CW, et al. J Clin Pharmacol. 2011 Jul;51(7):1035-42. doi: 10.1177/0091270010378408. Epub 2010 Oct 26. J Clin Pharmacol. 2011. PMID: 20978278 Clinical Trial.
179 results