Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

EELS (Ethical, Economic, Legal & Social) Article

Pharmacogenomic-guided drug development: regulatory perspective

The Pharmacogenomics Journal volume 2, pages 20–24 (2002)Cite this article

Pharmacogenetics (PGt) and now the more global term, pharmacogenomics (PGx), have come to the forefront after an evolutionary period of more than 30 years. Several transforming events in the past 5 years, not the least of which was the completion of the human genome sequence in 2001, have created an expectation that genetic and genomic information will produce sweeping changes in the practice of medicine and the prescribing of drugs. The almost daily press reports of new gene discoveries lend credence to the argument that personal genetic/genomic profiles will have a tremendous impact on health by the year 2010. This vision has not been without naysayers; however, we believe that the central issue is not whether PGt- or PGx-guided drug prescriptions will happen, but when and how.

This is a preview of subscription content, access via your institution

Access options

Buy article

Get time limited or full article access on ReadCube.

$32.00

Buy

All prices are NET prices.

References

  1. Joubert PH et al . Euro J Clin Pharmacol 1988 34: 363–368

  2. Joubert PH, Brandt HD . Euro J Clin Pharmacol 1990 39: 183–186

  3. Kuivenhoven JA et al . N Engl J Med 1998 338: 86–93

    Article  CAS  Google Scholar 

  4. Narod SA et al . Lancet 2000 356: 1876–1881

Download references

Author information

Authors and Affiliations

  1. Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA

    L J Lesko

  2. Office of the Center Director, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA

    J Woodcock

Authors
  1. L J Lesko
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. J Woodcock
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to L J Lesko.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Lesko, L., Woodcock, J. Pharmacogenomic-guided drug development: regulatory perspective. Pharmacogenomics J 2, 20–24 (2002). https://doi.org/10.1038/sj.tpj.6500046

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.tpj.6500046

This article is cited by

Search

Advanced search

Quick links