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Items: 1 to 20 of 240

1.

Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration.

Zineh I, Pacanowski MA.

Pharmacotherapy. 2011 Aug;31(8):729-35. doi: 10.1592/phco.31.8.729.

PMID:
21923598
2.

DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA.

Lesko LJ, Zineh I.

Pharmacogenomics. 2010 Apr;11(4):507-12. doi: 10.2217/pgs.10.16.

3.

The regulation of pharmacogenomics-based drugs and policy making.

Issa AM.

Curr Top Med Chem. 2004;4(13):1455-60.

PMID:
15379657
4.

Progress in pharmacogenomics and its promise for medicine.

Blake CA, Sobel BE.

Exp Biol Med (Maywood). 2008 Dec;233(12):1482-3. doi: 10.3181/0806-S-208. Epub 2008 Oct 10.

PMID:
18849537
5.

Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.

Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A.

J Clin Pharmacol. 2003 Apr;43(4):342-58.

PMID:
12723455
6.
7.

Regulatory approval for new pharmacogenomic tests: a comparative overview.

Joly Y, Koutrikas G, Tassé AM, Issa A, Carleton B, Hayden M, Rieder MJ, Ramos-Paque E, Avard D.

Food Drug Law J. 2011;66(1):1-24, i. Review.

PMID:
24505844
8.

Regulatory agency consideration of pharmacogenomics.

Pendergast MK.

Exp Biol Med (Maywood). 2008 Dec;233(12):1498-503. doi: 10.3181/0806-S-207. Epub 2008 Oct 10. Review.

PMID:
18849547
9.

Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.

Lesko LJ, Woodcock J.

Nat Rev Drug Discov. 2004 Sep;3(9):763-9. Review.

PMID:
15340386
10.
11.

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. doi: 10.1592/phco.28.8.992.

PMID:
18657016
13.

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. doi: 10.2217/14622416.10.1.111.

PMID:
19102720
15.

Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop.

Hinman L, Spear B, Tsuchihashi Z, Kelly J, Bross P, Goodsaid F, Kalush F.

Pharmacogenomics. 2009 Jan;10(1):127-36. doi: 10.2217/14622416.10.1.127.

16.

Pharmacogenetics: from discovery to patient care.

Shin J, Kayser SR, Langaee TY.

Am J Health Syst Pharm. 2009 Apr 1;66(7):625-37. doi: 10.2146/ajhp080170. Review.

PMID:
19299369
17.

Pharmacogenomics: translating functional genomics into rational therapeutics.

Evans WE, Relling MV.

Science. 1999 Oct 15;286(5439):487-91. Review.

PMID:
10521338
18.

Implementing the U.S. FDA guidance on pharmacogenomic data submissions.

Goodsaid F, Frueh FW.

Environ Mol Mutagen. 2007 Jun;48(5):354-8.

PMID:
17567848
19.

The history and contemporary challenges of the US Food and Drug Administration.

Borchers AT, Hagie F, Keen CL, Gershwin ME.

Clin Ther. 2007 Jan;29(1):1-16.

PMID:
17379043
20.

Enabling pharmacogenomic clinical trials through sampling.

Warner A, Nelsen A, Bhathena A, Fitzgerald K, Gilardi S, Kelso E, Knoppers B, McLeod HL, Nelson R, Uyama Y, Weisman J, Rudman A.

Pharmacogenomics. 2010 Dec;11(12):1649-54. doi: 10.2217/pgs.10.139.

PMID:
21142907

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