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Items: 1 to 20 of 176

1.

Molecular biomarkers: a US FDA effort.

Hong H, Goodsaid F, Shi L, Tong W.

Biomark Med. 2010 Apr;4(2):215-25. doi: 10.2217/bmm.09.81. Review.

PMID:
20406066
2.

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
3.
4.

What's next after 50 years of psychiatric drug development: an FDA perspective.

Laughren TP.

J Clin Psychiatry. 2010 Sep;71(9):1196-204. doi: 10.4088/JCP.10m06262gry.

PMID:
20923624
5.

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
6.
7.

Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.

Sapsford KE, Tezak Z, Kondratovich M, Pacanowski MA, Zineh I, Mansfield E.

Ther Deliv. 2010 Nov;1(5):631-41.

PMID:
22833953
8.

A rational regulatory approach for positron emission tomography imaging probes: from "first in man" to NDA approval and reimbursement.

Barrio JR, Marcus CS, Hung JC, Keppler JS.

Mol Imaging Biol. 2004 Nov-Dec;6(6):361-7.

PMID:
15564146
9.

Executive Summary of the National Cancer Institute Workshop: Highlights and recommendations.

Lieberman R, Nelson WG, Sakr WA, Meyskens FL Jr, Klein EA, Wilding G, Partin AW, Lee JJ, Lippman SM.

Urology. 2001 Apr;57(4 Suppl 1):4-27.

PMID:
11295590
10.

A prototypical process for creating evidentiary standards for biomarkers and diagnostics.

Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K.

Clin Pharmacol Ther. 2008 Feb;83(2):368-71. Epub 2007 Dec 19.

PMID:
18091762
11.

Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).

Weaver J, Grenade LL, Kwon H, Avigan M.

Dermatol Ther. 2009 May-Jun;22(3):204-15. doi: 10.1111/j.1529-8019.2009.01233.x. Review.

PMID:
19453344
12.

U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

Wing DA, Powers B, Hickok D.

Obstet Gynecol. 2010 Apr;115(4):825-33. doi: 10.1097/AOG.0b013e3181d53843.

PMID:
20308845
13.

Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs.

Surh LC, Pacanowski MA, Haga SB, Hobbs S, Lesko LJ, Gottlieb S, Papaluca-Amati M, Patterson SD, Hughes AR, Kim MJ, Close SL, Mosteller M, Zineh I, Dechairo B, Cohen NA.

Pharmacogenomics. 2010 Dec;11(12):1637-47. doi: 10.2217/pgs.10.138.

PMID:
21142906
14.

Translational medicine and the value of biomarker qualification.

Goodsaid FM, Mendrick DL.

Sci Transl Med. 2010 Sep 1;2(47):47ps44. doi: 10.1126/scitranslmed.3001040.

PMID:
20811041
15.

A review of patient-reported outcome labels in the United States: 2006 to 2010.

Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C.

Value Health. 2012 May;15(3):437-42. doi: 10.1016/j.jval.2011.11.032. Epub 2012 Feb 2.

16.

Vascular biomarkers and surrogates in cardiovascular disease.

Tardif JC, Heinonen T, Orloff D, Libby P.

Circulation. 2006 Jun 27;113(25):2936-42.

18.

Canadian and US drug approval times and safety considerations.

Rawson NS, Kaitin KI.

Ann Pharmacother. 2003 Oct;37(10):1403-8.

PMID:
14519031
19.

Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.

Cross J, Lee H, Westelinck A, Nelson J, Grudzinskas C, Peck C.

Pharmacoepidemiol Drug Saf. 2002 Sep;11(6):439-46.

PMID:
12426927
20.

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