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Items: 41

1.

Molecular diagnostics clinical utility strategy: a six-part framework.

Frueh FW, Quinn B.

Expert Rev Mol Diagn. 2014 Sep;14(7):777-86. doi: 10.1586/14737159.2014.933075. Epub 2014 Aug 9. Review.

PMID:
25109921
2.

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

Parkinson DR, McCormack RT, Keating SM, Gutman SI, Hamilton SR, Mansfield EA, Piper MA, Deverka P, Frueh FW, Jessup JM, McShane LM, Tunis SR, Sigman CC, Kelloff GJ.

Clin Cancer Res. 2014 Mar 15;20(6):1428-44. doi: 10.1158/1078-0432.CCR-13-2961.

3.

Regulation, reimbursement, and the long road of implementation of personalized medicine--a perspective from the United States.

Frueh FW.

Value Health. 2013 Sep-Oct;16(6 Suppl):S27-31. doi: 10.1016/j.jval.2013.06.009.

4.

Providing patients with pharmacogenetic test results affects adherence to statin therapy: results of the Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS) trial.

Charland SL, Agatep BC, Herrera V, Schrader B, Frueh FW, Ryvkin M, Shabbeer J, Devlin JJ, Superko HR, Stanek EJ.

Pharmacogenomics J. 2014 Jun;14(3):272-80. doi: 10.1038/tpj.2013.27. Epub 2013 Aug 27.

PMID:
23979174
5.
6.

On rat poison and human medicines: personalizing warfarin therapy.

Frueh FW.

Trends Mol Med. 2012 Apr;18(4):201-5. doi: 10.1016/j.molmed.2012.01.006. Epub 2012 Feb 28.

PMID:
22382089
7.

Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey.

Stanek EJ, Sanders CL, Taber KA, Khalid M, Patel A, Verbrugge RR, Agatep BC, Aubert RE, Epstein RS, Frueh FW.

Clin Pharmacol Ther. 2012 Mar;91(3):450-8. doi: 10.1038/clpt.2011.306. Epub 2012 Jan 25.

PMID:
22278335
8.

Considerations for safety pharmacogenetics in clinical practice.

Frueh FW.

Drug Discov Today. 2011 Oct;16(19-20):898-901. doi: 10.1016/j.drudis.2011.08.009. Epub 2011 Aug 24. Review.

PMID:
21888988
9.

The future of direct-to-consumer clinical genetic tests.

Frueh FW, Greely HT, Green RC, Hogarth S, Siegel S.

Nat Rev Genet. 2011 Jun 1;12(7):511-5. doi: 10.1038/nrg3026. Review.

10.

Impact of proton pump inhibitors on the effectiveness of clopidogrel after coronary stent placement: the clopidogrel Medco outcomes study.

Kreutz RP, Stanek EJ, Aubert R, Yao J, Breall JA, Desta Z, Skaar TC, Teagarden JR, Frueh FW, Epstein RS, Flockhart DA.

Pharmacotherapy. 2010 Aug;30(8):787-96. doi: 10.1592/phco.30.8.787.

PMID:
20653354
12.

Back to the future: why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine.

Frueh FW.

Pharmacogenomics. 2009 Jul;10(7):1077-81. doi: 10.2217/pgs.09.62. Review.

PMID:
19604080
13.

Payer perspectives on pharmacogenomics testing and drug development.

Epstein RS, Frueh FW, Geren D, Hummer D, McKibbin S, O'Connor S, Randhawa G, Zelman B.

Pharmacogenomics. 2009 Jan;10(1):149-51. doi: 10.2217/14622416.10.1.149.

14.

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.

Considerations for a business model for the effective integration of novel biomarkers into drug development.

Frueh FW.

Per Med. 2008 Nov;5(6):641-649. doi: 10.2217/17410541.5.6.641.

PMID:
29788620
16.

The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies.

Shi L, Jones WD, Jensen RV, Harris SC, Perkins RG, Goodsaid FM, Guo L, Croner LJ, Boysen C, Fang H, Qian F, Amur S, Bao W, Barbacioru CC, Bertholet V, Cao XM, Chu TM, Collins PJ, Fan XH, Frueh FW, Fuscoe JC, Guo X, Han J, Herman D, Hong H, Kawasaki ES, Li QZ, Luo Y, Ma Y, Mei N, Peterson RL, Puri RK, Shippy R, Su Z, Sun YA, Sun H, Thorn B, Turpaz Y, Wang C, Wang SJ, Warrington JA, Willey JC, Wu J, Xie Q, Zhang L, Zhang L, Zhong S, Wolfinger RD, Tong W.

BMC Bioinformatics. 2008 Aug 12;9 Suppl 9:S10. doi: 10.1186/1471-2105-9-S9-S10.

17.

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
18.

Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective.

Amur S, Frueh FW, Lesko LJ, Huang SM.

Biomark Med. 2008 Jun;2(3):305-11. doi: 10.2217/17520363.2.3.305.

PMID:
20477416
19.

Strategic paths for biomarker qualification.

Goodsaid FM, Frueh FW, Mattes W.

Toxicology. 2008 Mar 20;245(3):219-23. doi: 10.1016/j.tox.2007.12.023. Epub 2008 Jan 6. Review.

PMID:
18280028
20.

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.

21.

Questions and answers about the Pilot Process for Biomarker Qualification at the FDA.

Goodsaid FM, Frueh FW.

Drug Discov Today Technol. 2007 Autumn;4(1):9-11. doi: 10.1016/j.ddtec.2007.10.005.

PMID:
24980714
22.

An integrated bioinformatics infrastructure essential for advancing pharmacogenomics and personalized medicine in the context of the FDA's Critical Path Initiative.

Tong W, Harris SC, Fang H, Shi L, Perkins R, Goodsaid F, Frueh FW.

Drug Discov Today Technol. 2007 Autumn;4(1):3-8. doi: 10.1016/j.ddtec.2007.10.008.

PMID:
24980713
23.

The emerging role of pharmacogenomics in biologics.

LacanĂ¡ E, Amur S, Mummanneni P, Zhao H, Frueh FW.

Clin Pharmacol Ther. 2007 Oct;82(4):466-71. Epub 2007 Aug 22. Review.

PMID:
17713469
24.

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
25.

The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program.

Orr MS, Goodsaid F, Amur S, Rudman A, Frueh FW.

Clin Pharmacol Ther. 2007 Feb;81(2):294-7. Review.

PMID:
17259954
26.

The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.

Goodsaid FM, Frueh FW, Mattes W.

Drug Discov Today Technol. 2007 Winter;4(2):47-50. doi: 10.1016/j.ddtec.2007.10.010.

PMID:
24980840
27.

The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.

MAQC Consortium, Shi L, Reid LH, Jones WD, Shippy R, Warrington JA, Baker SC, Collins PJ, de Longueville F, Kawasaki ES, Lee KY, Luo Y, Sun YA, Willey JC, Setterquist RA, Fischer GM, Tong W, Dragan YP, Dix DJ, Frueh FW, Goodsaid FM, Herman D, Jensen RV, Johnson CD, Lobenhofer EK, Puri RK, Schrf U, Thierry-Mieg J, Wang C, Wilson M, Wolber PK, Zhang L, Amur S, Bao W, Barbacioru CC, Lucas AB, Bertholet V, Boysen C, Bromley B, Brown D, Brunner A, Canales R, Cao XM, Cebula TA, Chen JJ, Cheng J, Chu TM, Chudin E, Corson J, Corton JC, Croner LJ, Davies C, Davison TS, Delenstarr G, Deng X, Dorris D, Eklund AC, Fan XH, Fang H, Fulmer-Smentek S, Fuscoe JC, Gallagher K, Ge W, Guo L, Guo X, Hager J, Haje PK, Han J, Han T, Harbottle HC, Harris SC, Hatchwell E, Hauser CA, Hester S, Hong H, Hurban P, Jackson SA, Ji H, Knight CR, Kuo WP, LeClerc JE, Levy S, Li QZ, Liu C, Liu Y, Lombardi MJ, Ma Y, Magnuson SR, Maqsodi B, McDaniel T, Mei N, Myklebost O, Ning B, Novoradovskaya N, Orr MS, Osborn TW, Papallo A, Patterson TA, Perkins RG, Peters EH, Peterson R, Philips KL, Pine PS, Pusztai L, Qian F, Ren H, Rosen M, Rosenzweig BA, Samaha RR, Schena M, Schroth GP, Shchegrova S, Smith DD, Staedtler F, Su Z, Sun H, Szallasi Z, Tezak Z, Thierry-Mieg D, Thompson KL, Tikhonova I, Turpaz Y, Vallanat B, Van C, Walker SJ, Wang SJ, Wang Y, Wolfinger R, Wong A, Wu J, Xiao C, Xie Q, Xu J, Yang W, Zhang L, Zhong S, Zong Y, Slikker W Jr.

Nat Biotechnol. 2006 Sep;24(9):1151-61.

28.

Impact of microarray data quality on genomic data submissions to the FDA.

Frueh FW.

Nat Biotechnol. 2006 Sep;24(9):1105-7. No abstract available.

PMID:
16964222
29.

Experience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.

Frueh FW, Rudman A, Simon K, Gutman S, Reed C, Dorner AJ.

Pharmacogenomics J. 2006 Sep-Oct;6(5):296-300. Epub 2006 Mar 28. No abstract available.

PMID:
16568150
30.

Pharmacogenomics steps toward personalized medicine.

Xie HG, Frueh FW.

Per Med. 2005 Nov;2(4):325-337. doi: 10.2217/17410541.2.4.325.

PMID:
29788578
31.

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
32.

Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential.

Shi L, Tong W, Fang H, Scherf U, Han J, Puri RK, Frueh FW, Goodsaid FM, Guo L, Su Z, Han T, Fuscoe JC, Xu ZA, Patterson TA, Hong H, Xie Q, Perkins RG, Chen JJ, Casciano DA.

BMC Bioinformatics. 2005 Jul 15;6 Suppl 2:S12.

33.

Microarray scanner calibration curves: characteristics and implications.

Shi L, Tong W, Su Z, Han T, Han J, Puri RK, Fang H, Frueh FW, Goodsaid FM, Guo L, Branham WS, Chen JJ, Xu ZA, Harris SC, Hong H, Xie Q, Perkins RG, Fuscoe JC.

BMC Bioinformatics. 2005 Jul 15;6 Suppl 2:S11.

34.

QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies.

Shi L, Tong W, Goodsaid F, Frueh FW, Fang H, Han T, Fuscoe JC, Casciano DA.

Expert Rev Mol Diagn. 2004 Nov;4(6):761-77. Review.

PMID:
15525219
35.

Regulatory acceptance of toxicogenomics data.

Frueh FW, Huang SM, Lesko LJ.

Environ Health Perspect. 2004 Aug;112(12):A663-4. No abstract available.

36.
37.

Pharmacogenetics: from bench to bedside.

Erlich H, Bonnet J, Frueh FW, Bertrand P, Schmitz G, Salvatore G, Little S, Lambert C, Baranova E, Siest G.

Clin Chem Lab Med. 2003 Apr;41(4):610-4. No abstract available.

PMID:
12747610
38.
39.

In situ synthesis of oligonucleotide arrays by using surface tension.

Butler JH, Cronin M, Anderson KM, Biddison GM, Chatelain F, Cummer M, Davi DJ, Fisher L, Frauendorf AW, Frueh FW, Gjerstad C, Harper TF, Kernahan SD, Long DQ, Pho M, Walker JA 2nd, Brennan TM.

J Am Chem Soc. 2001 Sep 19;123(37):8887-94.

PMID:
11552795
40.

Use of cDNA microarrays to analyze dioxin-induced changes in human liver gene expression.

Frueh FW, Hayashibara KC, Brown PO, Whitlock JP Jr.

Toxicol Lett. 2001 Jul 6;122(3):189-203.

PMID:
11489354
41.

Extent and character of phenobarbital-mediated changes in gene expression in the liver.

Frueh FW, Zanger UM, Meyer UA.

Mol Pharmacol. 1997 Mar;51(3):363-9.

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