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Workgroup report: Review of genomics data based on experience with mock submissions--view of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee.

Leighton JK, Brown P, Ellis A, Harlow P, Harrouk W, Pine PS, Robison T, Rosario L, Thompson K.

Environ Health Perspect. 2006 Apr;114(4):573-8. Review.PMID: 16581548 [PubMed - indexed for MEDLINE]Related articlesFree article

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 [PubMed - indexed for MEDLINE]Related articles

The impact of FDA guidance on pharmacogenomic data submissions on drug development.

Little S.

IDrugs. 2005 Aug;8(8):648-50.PMID: 16044373 [PubMed - indexed for MEDLINE]Related articles

Development of public toxicogenomics software for microarray data management and analysis.

Tong W, Harris S, Cao X, Fang H, Shi L, Sun H, Fuscoe J, Harris A, Hong H, Xie Q, Perkins R, Casciano D.

Mutat Res. 2004 May 18;549(1-2):241-53.PMID: 15120974 [PubMed - indexed for MEDLINE]Related articles

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 [PubMed - indexed for MEDLINE]Related articles

[Development of antituberculous drugs: current status and future prospects]

Tomioka H, Namba K.

Kekkaku. 2006 Dec;81(12):753-74. Review. Japanese. PMID: 17240921 [PubMed - indexed for MEDLINE]Related articles

[Toxicogenomics--a new paradigm of toxicology and birth of reverse toxicology]

Hirabayashi Y, Inoue T.

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2002;(120):39-52. Review. Japanese. PMID: 12638183 [PubMed - indexed for MEDLINE]Related articles

Use of toxicological information in drug design.

Matthews EJ, Benz RD, Contrera JF.

J Mol Graph Model. 2000 Dec;18(6):605-15.PMID: 11155316 [PubMed - indexed for MEDLINE]Related articles

Systems toxicology and the Chemical Effects in Biological Systems (CEBS) knowledge base.

Waters M, Boorman G, Bushel P, Cunningham M, Irwin R, Merrick A, Olden K, Paules R, Selkirk J, Stasiewicz S, Weis B, Van Houten B, Walker N, Tennant R.

EHP Toxicogenomics. 2003 Jan;111(1T):15-28.PMID: 12735106 [PubMed - indexed for MEDLINE]Related articles

Applications of toxicogenomics to nonclinical drug development: regulatory science considerations.

Sistare FD, Degeorge JJ.

Methods Mol Biol. 2008;460:239-61.PMID: 18449491 [PubMed - indexed for MEDLINE]Related articles

Genomics: an in vitro toxicology point of view.

Corvi R.

Altern Lab Anim. 2002 Dec;30 Suppl 2:129-31. Review.PMID: 12513664 [PubMed - indexed for MEDLINE]Related articles

Toward a public toxicogenomics capability for supporting predictive toxicology: survey of current resources and chemical indexing of experiments in GEO and ArrayExpress.

Williams-Devane CR, Wolf MA, Richard AM.

Toxicol Sci. 2009 Jun;109(2):358-71. Epub 2009 Mar 30.PMID: 19332651 [PubMed - indexed for MEDLINE]Related articles

ArrayTrack--supporting toxicogenomic research at the U.S. Food and Drug Administration National Center for Toxicological Research.

Tong W, Cao X, Harris S, Sun H, Fang H, Fuscoe J, Harris A, Hong H, Xie Q, Perkins R, Shi L, Casciano D.

Environ Health Perspect. 2003 Nov;111(15):1819-26. Review.PMID: 14630514 [PubMed - indexed for MEDLINE]Related articlesFree article

Genomics and systems biology--how relevant are the developments to veterinary pharmacology, toxicology and therapeutics?

Witkamp RF.

J Vet Pharmacol Ther. 2005 Jun;28(3):235-45. Review.PMID: 15953196 [PubMed - indexed for MEDLINE]Related articles

Application of toxicogenomics to toxicology: basic concepts in the analysis of microarray data.

Irwin RD, Boorman GA, Cunningham ML, Heinloth AN, Malarkey DE, Paules RS.

Toxicol Pathol. 2004 Mar-Apr;32 Suppl 1:72-83. Review.PMID: 15209406 [PubMed - indexed for MEDLINE]Related articles

An overview of toxicogenomics.

Hamadeh HK, Amin RP, Paules RS, Afshari CA.

Curr Issues Mol Biol. 2002 Apr;4(2):45-56. Review.PMID: 11931569 [PubMed - indexed for MEDLINE]Related articlesFree article

The promise of toxicogenomics.

Waring JF, Halbert DN.

Curr Opin Mol Ther. 2002 Jun;4(3):229-35. Review.PMID: 12139308 [PubMed - indexed for MEDLINE]Related articles

FDA toxicity databases and real-time data entry.

Arvidson KB.

Toxicol Appl Pharmacol. 2008 Nov 15;233(1):17-9. Epub 2008 Jul 2.PMID: 18656494 [PubMed - indexed for MEDLINE]Related articles

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 [PubMed - indexed for MEDLINE]Related articles

Toxicogenomics, drug discovery, and the pathologist.

Boorman GA, Anderson SP, Casey WM, Brown RH, Crosby LM, Gottschalk K, Easton M, Ni H, Morgan KT.

Toxicol Pathol. 2002 Jan-Feb;30(1):15-27. Review.PMID: 11890469 [PubMed - indexed for MEDLINE]Related articles