Bibliography
- Lesko LJ , WoodcockJ: Pharmacogenomic-guided drug development: a regulatory perspective.Pharmacogenomics J.2(1) , 20–24 (2002).
- Lesko LJ , WoodcockJ: Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.Nat. Rev. Drug Discov.9 , 763–769 (2004).
- Lesko LJ , SalernoRA, SpearBB et al.: Pharmacogenetics and pharmacogenomics in drug development and regulatory decision-making: report of the first FDA–PWG–PhRMA–DruSafe workshop.J. Clin. Pharmacol.43(4) , 342–358 (2003).
- Zineh I , LeskoLJ: Pharmacogenetics in medicine: barriers, critical factors and a framework for dialogue.Per. Med.6(4) , 359–361 (2009).
- Contopoulos-Ioannidis DG , AlexiouGA, GouviasTC et al.: Life cycle of translational research for medical interventions.Science321(5894) , 1298–1299 (2008).
▪ Websites
- Guidance for Industry: Pharmacogenomics Data Submissions (March 2005)www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126957.pdf
- Table of Valid Genomic Biomarkers in the Context of Drug Labelswww.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm
- International Serious Adverse Event Consortiumwww.saeconsortium.org