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Items: 1 to 20 of 118

1.

Pharmacogenomics: a new clinical or regulatory paradigm? European experiences of pharmacogenomics in drug regulation and regulatory initiatives.

Prasad K, Breckenridge A.

Drug Discov Today. 2011 Oct;16(19-20):867-72. doi: 10.1016/j.drudis.2011.08.016. Review.

PMID:
21920454
2.

The regulation of pharmacogenomics-based drugs and policy making.

Issa AM.

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

PMID:
15379657
3.

The biomarker is not the end.

Nohaile M.

Drug Discov Today. 2011 Oct;16(19-20):878-83. doi: 10.1016/j.drudis.2011.08.011. Review.

PMID:
21888986
4.

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
5.

Generating and weighing evidence in drug development and regulatory decision making: 5th US FDA-DIA workshop on pharmacogenomics.

Shaw PM, Zineh I.

Pharmacogenomics. 2010 Dec;11(12):1629-35. doi: 10.2217/pgs.10.142.

PMID:
21142905
6.

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

Otsubo Y, Ishiguro A, Uyama Y.

Pharmacogenomics. 2013 Jan;14(2):195-203. doi: 10.2217/pgs.12.194. Review.

PMID:
23327579
7.

Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective.

Maliepaard M, Nofziger C, Papaluca M, Zineh I, Uyama Y, Prasad K, Grimstein C, Pacanowski M, Ehmann F, Dossena S, Paulmichl M.

Nat Rev Drug Discov. 2013 Feb;12(2):103-15. doi: 10.1038/nrd3931. Review.

PMID:
23370249
8.
9.
10.

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
11.

Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal.

Salerno RA, Lesko LJ.

Pharmacogenomics. 2004 Jan;5(1):25-30. No abstract available.

12.

Pharmacogenetics in Europe: barriers and opportunities.

Gurwitz D, Zika E, Hopkins MM, Gaisser S, Ibarreta D.

Public Health Genomics. 2009;12(3):134-41. doi: 10.1159/000189625.

13.

A regulatory protocol for pharmacogenomics services.

Bristol LA.

Pharmacogenomics J. 2002;2(2):83-6. No abstract available.

PMID:
12049179
14.

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
15.

Development and regulatory strategies for drug and diagnostic co-development.

Hinman LM, Carl KM, Spear BB, Salerno RA, Becker RL, Abbott BM, Kelly JF, Mansfield E, Katz RG, Harper C, Day SP, Pacanowski MA, Pignato W.

Pharmacogenomics. 2010 Dec;11(12):1669-75. doi: 10.2217/pgs.10.141.

PMID:
21142909
16.

Drug development in oncology: a regulatory perspective.

Augustus S.

Am J Ther. 2011 Jul;18(4):323-31. doi: 10.1097/MJT.0b013e3181d1d833.

PMID:
20335790
17.

Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine.

Zineh I, Huang SM.

Biomark Med. 2011 Dec;5(6):705-13. doi: 10.2217/bmm.11.90. Review.

PMID:
22103607
18.

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
19.

How pharmacogenomics will impact the federal regulation of clinical trials and the new drug approval process.

Binzak BA.

Food Drug Law J. 2003;58(1):103-27. No abstract available.

PMID:
12739592
20.

A review of public policy issues in promoting the development and commercialization of pharmacogenomic applications: challenges and implications.

Garrison LP Jr, Carlson RJ, Carlson JJ, Kuszler PC, Meckley LM, Veenstra DL.

Drug Metab Rev. 2008;40(2):377-401. doi: 10.1080/03602530801952500 . Review.

PMID:
18464050
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