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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: bonapace c. Clin Pharmacol Ther. 2007 Feb;81(2):213-21. doi: 10.1038/sj.clpt.6100051. Clin Pharmacol Ther. 2007. PMID: 17259946
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Khin NA, Francis G, Mulinde J, Grandinetti C, Skeete R, Yu B, Ayalew K, Cho SJ, Fisher A, Kleppinger C, Ayala R, Bonapace C, Dasgupta A, Kronstein PD, Vinter S. Khin NA, et al. Among authors: bonapace c. Clin Pharmacol Ther. 2020 Nov;108(5):949-963. doi: 10.1002/cpt.1794. Epub 2020 Mar 28. Clin Pharmacol Ther. 2020. PMID: 31958142
Pharmacokinetics of cefepime in patients with thermal burn injury.
Bonapace CR, White RL, Friedrich LV, Norcross ED, Bosso JA. Bonapace CR, et al. Antimicrob Agents Chemother. 1999 Dec;43(12):2848-54. doi: 10.1128/AAC.43.12.2848. Antimicrob Agents Chemother. 1999. PMID: 10582870 Free PMC article. Clinical Trial.
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