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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.

Genomic information has the potential to revolutionize pharmacologic therapies at many levels. The process of drug discovery may be transformed by this knowledge. Extensive genetic data will promote understanding of the molecular genetic contribution to many diseases. Genes and gene products suspected of being involved in disease pathogenesis will become new targets for intervention, and will stimulate new drug discovery programs. Conversely, gene expression profiling is being used currently to gain new insights into the molecular mechanism of drug actions, and the drug–disease interaction. Taken together, these techniques are expected to yield major advances in identifying drug candidates.

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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

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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

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  1. L J Lesko
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  2. J Woodcock
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Correspondence to L J Lesko.

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

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

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