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Items: 1 to 20 of 138

1.

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
2.

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.

3.

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
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.

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
6.

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
7.

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
8.
9.

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
10.

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
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.

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
13.

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
14.

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
15.
16.

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
17.

DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA.

Lesko LJ, Zineh I.

Pharmacogenomics. 2010 Apr;11(4):507-12. doi: 10.2217/pgs.10.16.

18.

The role of ADME pharmacogenomics in early clinical trials: perspective of the Industry Pharmacogenomics Working Group (I-PWG).

Tremaine L, Brian W, DelMonte T, Francke S, Groenen P, Johnson K, Li L, Pearson K, Marshall JC.

Pharmacogenomics. 2015 Dec;16(18):2055-67. doi: 10.2217/pgs.15.141. Epub 2015 Nov 30. Review.

PMID:
26616152
19.
20.

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

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