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Items: 1 to 20 of 155

1.

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.

2.
3.

Biomarkers of the immunomodulatory effect of immunosuppressive drugs in transplant recipients.

Millán O, Urtasun N, Brunet M.

Transplant Rev (Orlando). 2009 Apr;23(2):120-8. doi: 10.1016/j.trre.2009.01.006. Review.

PMID:
19298943
4.

Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.

Wagner JA, Williams SA, Webster CJ.

Clin Pharmacol Ther. 2007 Jan;81(1):104-7.

PMID:
17186007
5.

Can we use biomarkers and functional assays to implement personalized therapies in transplantation?

Sawitzki B, Pascher A, Babel N, Reinke P, Volk HD.

Transplantation. 2009 Jun 15;87(11):1595-601. doi: 10.1097/TP.0b013e3181a6b2cf.

PMID:
19502949
6.

Towards the identification of biomarkers of transplantation tolerance.

Turka LA, Lechler RI.

Nat Rev Immunol. 2009 Jul;9(7):521-6. doi: 10.1038/nri2568.

PMID:
19483711
7.

A cost-effectiveness approach to the qualification and acceptance of biomarkers.

Williams SA, Slavin DE, Wagner JA, Webster CJ.

Nat Rev Drug Discov. 2006 Nov;5(11):897-902. Review.

PMID:
17080026
8.

Biomarkers in solid organ transplantation.

Gieser G, Harigaya H, Colangelo PM, Burckart G.

Clin Pharmacol Ther. 2011 Aug;90(2):217-20. doi: 10.1038/clpt.2011.75.

PMID:
21772300
9.

Imaging biomarkers as surrogate endpoints for drug development.

Richter WS.

Eur J Nucl Med Mol Imaging. 2006 Jul;33 Suppl 1:6-10.

PMID:
16721568
10.

The applications of biomarkers in early clinical drug development to improve decision-making processes.

Kuhlmann J.

Ernst Schering Res Found Workshop. 2007;(59):29-45. Review.

PMID:
17117713
11.

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.

Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W.

Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625.

PMID:
20458315
12.

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
13.

How a US regulator can encourage new science.

Throckmorton DC.

Clin Pharmacol Ther. 2009 Nov;86(5):471-2. doi: 10.1038/clpt.2009.188.

PMID:
19844222
14.

Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European consensus conference.

Wallemacq P, Armstrong VW, Brunet M, Haufroid V, Holt DW, Johnston A, Kuypers D, Le Meur Y, Marquet P, Oellerich M, Thervet E, Toenshoff B, Undre N, Weber LT, Westley IS, Mourad M.

Ther Drug Monit. 2009 Apr;31(2):139-52. doi: 10.1097/FTD.0b013e318198d092.

PMID:
19177031
15.

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
16.

Report from the National Transplantation Pregnancy Registry: outcomes of pregnancy after transplantation.

Armenti VT, Daller JA, Constantinescu S, Silva P, Radomski JS, Moritz MJ, Gaughan WJ, McGrory CH, Coscia LA.

Clin Transpl. 2006:57-70.

PMID:
18368705
17.

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.

PMID:
18091762
18.

Novel biomarkers of acute kidney toxicity.

Goodsaid FM, Blank M, Dieterle F, Harlow P, Hausner E, Sistare F, Thompson A, Vonderscher J.

Clin Pharmacol Ther. 2009 Nov;86(5):490-6. doi: 10.1038/clpt.2009.149.

PMID:
19710639
19.

Association between pharmacodynamic biomarkers and clinical events in the early phase after kidney transplantation: a single-center pilot study.

Wieland E, Shipkova M, Martius Y, Hasche G, Klett C, Bolley R, Olbricht CJ.

Ther Drug Monit. 2011 Jun;33(3):341-9. doi: 10.1097/FTD.0b013e3182188675.

PMID:
21516058
20.

Promises of biomarkers in drug development--a reality check.

Marrer E, Dieterle F.

Chem Biol Drug Des. 2007 Jun;69(6):381-94. Review.

PMID:
17581232
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