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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: ramchandani rp. Clin Pharmacol Ther. 2007 Feb;81(2):213-21. doi: 10.1038/sj.clpt.6100051. Clin Pharmacol Ther. 2007. PMID: 17259946
Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma.
Goodman VL, Rock EP, Dagher R, Ramchandani RP, Abraham S, Gobburu JV, Booth BP, Verbois SL, Morse DE, Liang CY, Chidambaram N, Jiang JX, Tang S, Mahjoob K, Justice R, Pazdur R. Goodman VL, et al. Among authors: ramchandani rp. Clin Cancer Res. 2007 Mar 1;13(5):1367-73. doi: 10.1158/1078-0432.CCR-06-2328. Clin Cancer Res. 2007. PMID: 17332278 Review.
Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate.
Brave M, Goodman V, Kaminskas E, Farrell A, Timmer W, Pope S, Harapanhalli R, Saber H, Morse D, Bullock J, Men A, Noory C, Ramchandani R, Kenna L, Booth B, Gobburu J, Jiang X, Sridhara R, Justice R, Pazdur R. Brave M, et al. Among authors: ramchandani r. Clin Cancer Res. 2008 Jan 15;14(2):352-9. doi: 10.1158/1078-0432.CCR-07-4175. Clin Cancer Res. 2008. PMID: 18223208
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: ramchandani r. Clin Cancer Res. 2008 Sep 1;14(17):5325-31. doi: 10.1158/1078-0432.CCR-08-0308. Clin Cancer Res. 2008. PMID: 18765523
56 results