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Items: 1 to 20 of 115

1.

Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease.

Zhang L, Xu N, Xiao S, Arya V, Zhao P, Lesko LJ, Huang SM.

J Clin Pharmacol. 2012 Jan;52(1 Suppl):79S-90S. doi: 10.1177/0091270011415410.

PMID:
22232757
2.

Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives.

Ibrahim S, Honig P, Huang SM, Gillespie W, Lesko LJ, Williams RL.

J Clin Pharmacol. 2000 Jan;40(1):31-8. Review.

PMID:
10631619
3.

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.

Clin Pharmacol Ther. 2009 Nov;86(5):475-9. doi: 10.1038/clpt.2009.190.

PMID:
19844224
4.

A systematic comparison of cockcroft-gault and modification of diet in renal disease equations for classification of kidney dysfunction and dosage adjustment.

Park EJ, Wu K, Mi Z, Dong T, Lawrence JP, Ko CW, Huang SM, Zhang L, Crentsil V, Zhang J, Xu NN.

Ann Pharmacother. 2012 Sep;46(9):1174-87. doi: 10.1345/aph.1Q757. Epub 2012 Aug 28.

PMID:
22932303
5.

Comparison of the Modification of Diet in Renal Disease and Cockcroft-Gault equations for dosing antimicrobials.

Hermsen ED, Maiefski M, Florescu MC, Qiu F, Rupp ME.

Pharmacotherapy. 2009 Jun;29(6):649-55. doi: 10.1592/phco.29.6.649.

PMID:
19476418
6.

Pharmacokinetics and dosage adjustment in patients with renal dysfunction.

Verbeeck RK, Musuamba FT.

Eur J Clin Pharmacol. 2009 Aug;65(8):757-73. doi: 10.1007/s00228-009-0678-8. Epub 2009 Jun 20. Review.

PMID:
19543887
7.

Comparison of estimated glomerular filtration rate with estimated creatinine clearance in the dosing of drugs requiring adjustments in elderly patients with declining renal function.

Spruill WJ, Wade WE, Cobb HH 3rd.

Am J Geriatr Pharmacother. 2008 Aug;6(3):153-60. doi: 10.1016/j.amjopharm.2008.07.002.

PMID:
18775390
8.

Implications of using modification of diet in renal disease versus Cockcroft-Gault equations for renal dosing adjustments.

Moranville MP, Jennings HR.

Am J Health Syst Pharm. 2009 Jan 15;66(2):154-61. doi: 10.2146/ajhp080071.

PMID:
19139480
9.
10.

Design, conduct, analysis, and interpretation of clinical studies in patients with impaired kidney function.

Tortorici MA, Cutler D, Zhang L, Pfister M.

J Clin Pharmacol. 2012 Jan;52(1 Suppl):109S-18S. doi: 10.1177/0091270011416364.

PMID:
22232746
11.

Therapeutic protein-drug interactions and implications for drug development.

Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, Lesko LJ.

Clin Pharmacol Ther. 2010 Apr;87(4):497-503. doi: 10.1038/clpt.2009.308. Epub 2010 Mar 3.

PMID:
20200513
12.

Drug development perspective on pharmacokinetic studies of new drugs in patients with renal impairment.

Lalonde RL, Wagner JA.

Clin Pharmacol Ther. 2009 Nov;86(5):557-61. doi: 10.1038/clpt.2009.182. Epub 2009 Sep 23.

PMID:
19776736
14.

The old and new methods of assessing kidney function.

Steffl JL, Bennett W, Olyaei AJ.

J Clin Pharmacol. 2012 Jan;52(1 Suppl):63S-71S. doi: 10.1177/0091270011420260.

PMID:
22232755
15.
16.

Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications.

Zhang Y, Zhang L, Abraham S, Apparaju S, Wu TC, Strong JM, Xiao S, Atkinson AJ Jr, Thummel KE, Leeder JS, Lee C, Burckart GJ, Lesko LJ, Huang SM.

Clin Pharmacol Ther. 2009 Mar;85(3):305-11. doi: 10.1038/clpt.2008.208. Epub 2008 Nov 19.

PMID:
19020495
17.

[Comparison of methods for evaluating renal function (Data of Kaunas University of Medicine Hospital in 2006)].

Kuzminskis V, Skarupskiene I, Bumblyte IA, Kardauskaite Z, Uogintaite J.

Medicina (Kaunas). 2007;43 Suppl 1:46-51. Lithuanian.

18.

Performance of the chronic kidney disease-epidemiology study equations for estimating glomerular filtration rate before and after nephrectomy.

Lane BR, Demirjian S, Weight CJ, Larson BT, Poggio ED, Campbell SC.

J Urol. 2010 Mar;183(3):896-901. doi: 10.1016/j.juro.2009.11.023. Epub 2010 Jan 18.

PMID:
20083272
19.

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

Huang SM, Temple R, Throckmorton DC, Lesko LJ.

Clin Pharmacol Ther. 2007 Feb;81(2):298-304. Review.

PMID:
17259955
20.

Effects of varying degrees of renal impairment on the pharmacokinetics of duloxetine: analysis of a single-dose phase I study and pooled steady-state data from phase II/III trials.

Lobo ED, Heathman M, Kuan HY, Reddy S, O'Brien L, Gonzales C, Skinner M, Knadler MP.

Clin Pharmacokinet. 2010 May;49(5):311-21. doi: 10.2165/11319330-000000000-00000.

PMID:
20384393
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