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Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JVS, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y, Zheng JJ. Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions—a Survey of 31 New Drug Applications Submitted Between 2005 and 2006. Clinical Pharmacology & Therapeutics. 2006 Dec 27;81(2):213–21. doi: 10.1038/sj.clpt.6100051. |