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Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop

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References

  1. Lesko LJ, Salerno RA, Spear B, Anderson DC, Anderson T, Brazell C et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. J Clin Pharmacol 2003; 43: 342–358.

    Article  CAS  Google Scholar 

  2. Salerno RA, Lesko LJ . Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) Proposal. Pharmacogenomics 2004; 5: 25–30.

    Article  Google Scholar 

  3. Guidance for Industry. Pharmacogenomics Data Submission 2005; Website: http://www.fda.gov/cder/genomics/regulatory.htm.

  4. Wang S, Cohen N, Katz D, Ruano G, Shaw P, Spear B . Retrospective validation of genomic boomarkers – what are the questions, challenges and strategies for developing useful relationships to clinical outcomes. Pharmacogenomics 2005, in press.

  5. Trepicchio WL, Essayan D, Hall ST, Schechter G, Tezak Z, Wang SJ et al. Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making. Pharmacogenomics 2005, in press.

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Authors and Affiliations

  1. Worldwide Regulatory Affairs, Pharma & Translational Medicine, Wyeth Research, Collegeville, PA, USA

    R A Salerno

  2. Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    L J Lesko

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  1. R A Salerno
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  2. L J Lesko
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Correspondence to R A Salerno or L J Lesko.

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Salerno, R., Lesko, L. Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop. Pharmacogenomics J 6, 78–81 (2006). https://doi.org/10.1038/sj.tpj.6500345

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