Chapter 21. Toxicogenomics for Regulatory Use: The View from the Bench

  1. Saura C. Sahu
  1. P. Ancian,
  2. S. Leuillet,
  3. S. Arthaud,
  4. J. J. Legrand and
  5. R. Forster

Published Online: 14 OCT 2008

DOI: 10.1002/9780470699638.ch21

Toxicogenomics: A Powerful Tool for Toxicity Assessment

Toxicogenomics: A Powerful Tool for Toxicity Assessment

How to Cite

Ancian, P., Leuillet, S., Arthaud, S., Legrand, J. J. and Forster, R. (2008) Toxicogenomics for Regulatory Use: The View from the Bench, in Toxicogenomics: A Powerful Tool for Toxicity Assessment (ed S. C. Sahu), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470699638.ch21

Editor Information

  1. Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Laurel, MD 20708, USA

Author Information

  1. CIT, Evreux, France

Publication History

  1. Published Online: 14 OCT 2008
  2. Published Print: 10 OCT 2008

ISBN Information

Print ISBN: 9780470518236

Online ISBN: 9780470699638

SEARCH

Keywords:

  • toxicogenomics and gene expression patterns;
  • gene expression data generation;
  • standard operating procedures (SOPs) and quality control (QC) checks;
  • bioinformatics and interpretation;
  • Working group and Microarray Quality Control (MAQC) project;
  • FDA Guideline on Pharmacogenomic data submissions;
  • preclinical drug safety tenet;
  • Voluntary Genomic Data Submission (VGDS)

Summary

This chapter contains sections titled:

  • Introduction

  • Objectives of Toxicogenomics

  • Conduct of In Vivo and Traditional Study Elements

  • Generation of Gene Expression Data

  • Bioinformatics and Interpretation

  • Study Documentation

  • Regulatory Submission

  • Conclusions

  • References