PubMed

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.PMID: 19844224 [PubMed - indexed for MEDLINE]Related articles

Pharmacogenetics--tailoring treatment for the outliers.

Woodcock J, Lesko LJ.

N Engl J Med. 2009 Feb 19;360(8):811-3. No abstract available. PMID: 19228625 [PubMed - indexed for MEDLINE]Related articles

A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity.

Kim MJ, Huang SM, Meyer UA, Rahman A, Lesko LJ.

J Clin Pharmacol. 2009 Feb;49(2):138-46. Review.PMID: 19179293 [PubMed - indexed for MEDLINE]Related articles

Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with 'what-ifs'.

Surh LC, Lesko LJ, Hobbs S, Gutman S, Minasian LM, Della Pasqua OE, Austin MJ, Lu K.

Pharmacogenomics. 2009 Jan;10(1):137-47.PMID: 19102723 [PubMed - indexed for MEDLINE]Related articles

4th US FDA-Drug Information Association pharmacogenomics workshop, held 10-12 December, 2007.

Frueh FW, Salerno RA, Lesko LJ, Hockett RD.

Pharmacogenomics. 2009 Jan;10(1):111-5.PMID: 19102720 [PubMed - indexed for MEDLINE]Related articles

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. Epub 2008 Nov 19.PMID: 19020495 [PubMed - indexed for MEDLINE]Related articles

Quantitative disease, drug, and trial models.

Gobburu JV, Lesko LJ.

Annu Rev Pharmacol Toxicol. 2009;49:291-301. Review.PMID: 18851702 [PubMed - indexed for MEDLINE]Related articles

The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics.

Lesko LJ.

Clin Pharmacol Ther. 2008 Sep;84(3):301-3. Review. No abstract available. PMID: 18714317 [PubMed - indexed for MEDLINE]Related articles

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

Frueh FW, Amur S, Mummaneni P, Epstein RS, Aubert RE, DeLuca TM, Verbrugge RR, Burckart GJ, Lesko LJ.

Pharmacotherapy. 2008 Aug;28(8):992-8.PMID: 18657016 [PubMed - indexed for MEDLINE]Related articles

New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.

Huang SM, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, Abraham S, Habet SA, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Qiu W, Rahman A, Sobel S, Stifano T, Thummel K, Wei XX, Yasuda S, Zheng JH, Zhao H, Lesko LJ.

J Clin Pharmacol. 2008 Jun;48(6):662-70. Epub 2008 Mar 31. Review.PMID: 18378963 [PubMed - indexed for MEDLINE]Related articles

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.

J Clin Pharmacol. 2008 Feb;48(2):146-56.PMID: 18199891 [PubMed - indexed for MEDLINE]Related articles

Qualification of biomarkers for drug development in organ transplantation.

Burckart GJ, Amur S, Goodsaid FM, Lesko LJ, Frueh FW, Huang SM, Cavaille-Coll MW.

Am J Transplant. 2008 Feb;8(2):267-70. Epub 2007 Dec 18.PMID: 18093264 [PubMed - indexed for MEDLINE]Related articles

Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues.

Gage BF, Lesko LJ.

J Thromb Thrombolysis. 2008 Feb;25(1):45-51. Epub 2007 Oct 1. Review.PMID: 17906972 [PubMed - indexed for MEDLINE]Related articles

Personalized medicine: elusive dream or imminent reality?

Lesko LJ.

Clin Pharmacol Ther. 2007 Jun;81(6):807-16.PMID: 17505496 [PubMed - indexed for MEDLINE]Related articles

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 [PubMed - indexed for MEDLINE]Related articles

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.

Clin Pharmacol Ther. 2007 Feb;81(2):213-21.PMID: 17259946 [PubMed - indexed for MEDLINE]Related articles

Paving the critical path: how can clinical pharmacology help achieve the vision?

Lesko LJ.

Clin Pharmacol Ther. 2007 Feb;81(2):170-7. Review.PMID: 17259944 [PubMed - indexed for MEDLINE]Related articles

Scientific perspectives on drug transporters and their role in drug interactionst.

Zhang L, Strong JM, Qiu W, Lesko LJ, Huang SM.

Mol Pharm. 2006 Jan-Feb;3(1):62-9. Review.PMID: 16686370 [PubMed - indexed for MEDLINE]Related articles

Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.

Salerno RA, Lesko LJ.

Pharmacogenomics J. 2006 Mar-Apr;6(2):78-81. No abstract available. PMID: 16402087 [PubMed - indexed for MEDLINE]Related articles

The need for education in pharmacogenomics: a regulatory perspective.

Frueh FW, Goodsaid F, Rudman A, Huang SM, Lesko LJ.

Pharmacogenomics J. 2005;5(4):218-20. No abstract available. PMID: 16041391 [PubMed - indexed for MEDLINE]Related articles