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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
John K. Leighton, Paul Brown, Amy Ellis, Patricia Harlow, Wafa Harrouk, P. Scott Pine, Timothy Robison, Lilliam Rosario, and Karol Thompson
Environ Health Perspect. 2006 April; 114(4): 573–578. Published online 2005 November 3. doi: 10.1289/ehp.8318.
PMCID: PMC1440783
 Is Cited by the Following Articles in this Archive:
Validation of Analytical Methods for Biomarkers Employed in Drug Development
Cindy H. Chau, Olivier Rixe, Howard McLeod, and William D. Figg
Clin Cancer Res. Author manuscript; available in PMC 2009 September 15.
PMCID: PMC2744124
Published in final edited form as: Clin Cancer Res. 2008 October 1; 14(19): 5967–5976. doi: 10.1158/1078-0432.CCR-07-4535.
Manuscript: | Abstract | Full Text | PDF–521K |
Gene Expression Profiling and its Practice in Drug Development
Murty V Chengalvala, Vargheese M Chennathukuzhi, Daniel S Johnston, Panayiotis E Stevis, and Gregory S Kopf
Curr Genomics. 2007 June; 8(4): 262–270.
PMCID: PMC2430683
Importance of dosage standardization for interpreting transcriptomal signature profiles: Evidence from studies of xenoestrogens
Toshi Shioda, Jessica Chesnes, Kathryn R. Coser, Lihua Zou, Jingyung Hur, Kathleen L. Dean, Carlos Sonnenschein, Ana M. Soto, and Kurt J. Isselbacher
Proc Natl Acad Sci U S A. 2006 August 8; 103(32): 12033–12038. Published online 2006 August 1. doi: 10.1073/pnas.0605341103.
PMCID: PMC1525050