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Items: 1 to 20 of 132

1.

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
2.

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
3.

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.

4.

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
5.

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
6.

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
7.

Designing pharmacogenomic studies to be fit for purpose.

Burns DK, Hughes AR, Power A, Wang SJ, Patterson SD.

Pharmacogenomics. 2010 Dec;11(12):1657-67. doi: 10.2217/pgs.10.140.

PMID:
21142908
8.

Developing the evidence base for applying pharmacogenomics: proceeds from DIA Workshop IV--Breakout Session 1.

Armstrong M, Bromley C, Cohen N, Hunt CM, O'Neill R, Power A.

Pharmacogenomics. 2009 Jan;10(1):117-25. doi: 10.2217/14622416.10.1.117.

PMID:
19102721
9.

The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop.

Hinman LM, Huang SM, Hackett J, Koch WH, Love PY, Pennello G, Torres-Cabassa A, Webster C.

Pharmacogenomics J. 2006 Nov-Dec;6(6):375-80. Epub 2006 May 2. Review.

PMID:
16652120
10.

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
11.

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
12.

The regulation of pharmacogenomics-based drugs and policy making.

Issa AM.

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

PMID:
15379657
13.

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
14.

Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with 'what-ifs'.

Surh LC, Lesko LJ, Hobbs S, Gutman S, Minasian LM, Della Pasqua OE, Austin MJ, Lu K.

Pharmacogenomics. 2009 Jan;10(1):137-47. doi: 10.2217/14622416.10.1.137.

PMID:
19102723
15.

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. Epub 2011 Sep 6. Review.

PMID:
21920454
16.

Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011.

Warner AW, Bienfait KL, Bledsoe M, Burckart G, Flamion B, Knoppers B, Nelsen AJ, Rudman A, Sieffert NJ, Uyama Y.

Pharmacogenomics. 2013 Jan;14(1):103-12. doi: 10.2217/pgs.12.193. Erratum in: Pharmacogenomics. 2013 Apr;14(5):589-90.

PMID:
23252952
17.

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.

18.

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
19.

Neoliberal technocracy: explaining how and why the US Food and Drug Administration has championed pharmacogenomics.

Hogarth S.

Soc Sci Med. 2015 Apr;131:255-62. doi: 10.1016/j.socscimed.2015.01.023. Epub 2015 Jan 15.

PMID:
25661300
20.

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