Lesko L - Search Results

1

Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label.

Menon-Andersen D, Yu B, Madabushi R, Bhattaram V, Hao W, Uppoor RS, Mehta M, Lesko L, Temple R, Stockbridge N, Laughren T, Gobburu JV. Menon-Andersen D, et al. Among authors: lesko l. Clin Pharmacol Ther. 2011 Sep;90(3):471-4. doi: 10.1038/clpt.2011.149. Epub 2011 Jul 27. Clin Pharmacol Ther. 2011. PMID: 21796114 No abstract available.

2

Quantitative disease, drug, and trial models.

Gobburu JV, Lesko LJ. Gobburu JV, et al. Annu Rev Pharmacol Toxicol. 2009;49:291-301. doi: 10.1146/annurev.pharmtox.011008.145613. Annu Rev Pharmacol Toxicol. 2009. PMID: 18851702 Review.

3

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: lesko lj. Clin Pharmacol Ther. 2007 Feb;81(2):213-21. doi: 10.1038/sj.clpt.6100051. Clin Pharmacol Ther. 2007. PMID: 17259946

4

Drug interaction studies: study design, data analysis, and implications for dosing and labeling.

Huang SM, Temple R, Throckmorton DC, Lesko LJ. Huang SM, et al. Among authors: lesko lj. Clin Pharmacol Ther. 2007 Feb;81(2):298-304. doi: 10.1038/sj.clpt.6100054. Clin Pharmacol Ther. 2007. PMID: 17259955 Review.

5

When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective.

Huang SM, Temple R, Xiao S, Zhang L, Lesko LJ. Huang SM, et al. Among authors: lesko lj. Clin Pharmacol Ther. 2009 Nov;86(5):475-9. doi: 10.1038/clpt.2009.190. Clin Pharmacol Ther. 2009. PMID: 19844224

6

Therapeutic protein-drug interactions and implications for drug development.

Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, Lesko LJ. Huang SM, et al. Among authors: lesko lj. Clin Pharmacol Ther. 2010 Apr;87(4):497-503. doi: 10.1038/clpt.2009.308. Epub 2010 Mar 3. Clin Pharmacol Ther. 2010. PMID: 20200513

7

In vitro metabolic interaction studies: experience of the Food and Drug Administration.

Yuan R, Parmelee T, Balian JD, Uppoor RS, Ajayi F, Burnett A, Lesko LJ, Marroum P. Yuan R, et al. Among authors: lesko lj. Clin Pharmacol Ther. 1999 Jul;66(1):9-15. doi: 10.1016/S0009-9236(99)70048-2. Clin Pharmacol Ther. 1999. PMID: 10430104

8

Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.

Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV. Wang Y, et al. J Clin Pharmacol. 2008 Feb;48(2):146-56. doi: 10.1177/0091270007311111. J Clin Pharmacol. 2008. PMID: 18199891

9

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. Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000. Clin Pharmacokinet. 2011. PMID: 21895036

10

Pharmacokinetic-pharmacodynamic modeling of rivastigmine, a cholinesterase inhibitor, in patients with Alzheimer's disease.

Gobburu JV, Tammara V, Lesko L, Jhee SS, Sramek JJ, Cutler NR, Yuan R. Gobburu JV, et al. Among authors: lesko l. J Clin Pharmacol. 2001 Oct;41(10):1082-90. doi: 10.1177/00912700122012689. J Clin Pharmacol. 2001. PMID: 11583476 Clinical Trial.

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