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The use of toxicogenomic data in risk assessment: a regulatory perspective

Vivian S W Chan1, Mette Due Theilade

  • 1Innovative Therapeutics Group, Centre for Drug Administration, Health Sciences Authority, Singapore. Vivian_CHAN@hsa.gov.sg

Clinical Toxicology (Philadelphia, Pa.)
|April 13, 2005
PubMed

Insights

Genomic research advances toxicogenomics by linking gene expression to adverse effects. Robust toxicogenomics databases hold promise for drug safety assessment, pending validation of predictive value.

Area of Science:

  • Genomic research
  • Toxicology
  • Bioinformatics

Background:

  • Genomic research offers new insights into drug and xenobiotic toxicity mechanisms.
  • Numerous organizations are developing large toxicogenomics databases.
  • Linking gene expression patterns to specific toxicant effects is a key challenge.

Purpose of the Study:

  • To explore the potential of toxicogenomics databases in characterizing hazard.
  • To discuss the challenges and future directions in toxicogenomics research.
  • To examine the role of toxicogenomics data in regulatory decision-making for new drugs.

Main Methods:

  • Analysis of gene expression patterns.
  • Gene clustering techniques.
  • Database development and validation.

Main Results:

  • Toxicogenomics databases are expanding, offering potential for improved hazard characterization.
  • The robustness and predictive value of these databases are critical for future applications.
  • Regulatory bodies are exploring the use of toxicogenomics data, but cautiously.

Conclusions:

  • The future of toxicogenomics relies on the development of robust and reliable databases.
  • Regulatory use of toxicogenomics data in drug assessment will likely be case-by-case initially.
  • Further validation is needed to establish the predictive power of toxicogenomics databases.

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