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Pharmacometrics at FDA
Publications
2008
Garnett CE, Beasley N, Bhattaram VA, Jadhav PR, Madabushi R,Stockbridge N, Tornøe CW, Wang Y, Zhu H, Gobburu JV. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008 Jan; 48(1):13-8.
Gobburu J. Disease models. Clin Adv Hematol Oncol. 2008 Apr; 6(4):241-2.
Wang Y, Bhattaram AV, Jayhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA Pharmacometrics during 2004-2006. J Clin Pharmacol. 2008 Feb; 48(2):146-56
2007
Bhattaram, A.V. et al. Impact of pharmacokinetic review on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther. 81, 213-221 (2007).
Lesko LJ. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther. 2007 Feb;81(2):170-7. Review.
Powell JR, Gobburu JV. Pharmacometrics at FDA: Evolution and Impact on Decisions. Clin Pharmacol Ther. 2007 Jul;82(1):97-102.
Tornøe CW, Tworzyanski JJ, Imoisili MA, Alexander JJ, Korth-Bradley JM, Gobburu JV. Optimising piperacillin/tazobactam dosing in paediatrics. Int J Antimicrob Agents. 2007 Oct; 30(4):320-4.
2005
Bhattaram, A.V. et al. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications. AAPSJ 7, E503-E512 (2005).
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Date created: November 19, 2008 |
