Pharmacogenomics and personalized medicine issues and methodology

Handbook of Drug Monitoring Methods: Therapeutics and Drugs of Abuse

Volumn , Issue , 2008, Pages 211-223

  Wong, Steven H Y ^a  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

Author keywords

Biomarkers; cytochrome P450; methodology; personalized medicine; pharmacogenomics

Indexed keywords

EID: 77649202019     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-59745-031-7_11     Document Type: Chapter

References (46)

1. International Human Genome Sequencing consortium. Initial sequencing and analysis of the human genome. Nature 2001;409:860-921.
2. Venter JC, Adams MD, Myers EW, et al. The sequence of human genome. Science 2001;291: 1304-1351.
3. Guttmacher AE, Collins FS, Drazen JM, eds. Genomic medicine-articles form the New England Journal of Medicine. Johns Hopkins University Press, Baltimore, MD, and New England Journal of Medicine, Boston, MA, 2004, pp. 1-179.
4. Jicinio J, Wong M-L. Pharmacogenomics. Wiley-VCH, Weinheim, Germany, 2002, pp. 1-559.
5. Linder MW, Prough RA, Valdes R, Jr. Pharmacogenetics: a laboratory tool for optimizing therapeutic efficiency (review). Clin Chem 1997;43(2):254-266.
6. Wong SHY, Linder MW, Valdes R, Jr, ed. Pharmacogenomics and Proteomics-Enabling the Practice of Personalized Medicine. AACC Press, Washington, D. C., 2006, pp. 1-386.
7. White R, Wong SHY. Pharmacogenomics and its clinical applications. MLO Med Lab Obs 2005;37:20-27.
8. Weber WW. Pharmacogenetics. Oxford University Press, Oxford, UK, 1997, pp. 1-344.
9. Weinshilboum R. Inheritance and drug response. N Engl J Med, 2003;348:529-537.
10. Evans WE, McLeod HL. Pharmacogenomics-drug disposition, drug targets and side effects. N Engl J Med, 2003;348:538-549.
11. Schmitz G, Aslanidis C, Lackner KJ. Pharmacogenomics: implications for laboratory medicine. Clin Chem Acta 2001;308:43-53.
12. Personalized Medicine e-Symposium, June 21, 2006 (http://www. e-symposium. com/pm/archive. php)
13. O'Dell L, Doyle J. Opportunities in Pharmacogenomics-Market Research Analysis. May 2004.
14. Hopkins MM, Ibarreta D, Gaisser S, et al. Putting pharmacogenetics into practice. Nat Biotechnol 2006;24:403-410.
15. Salerno RA, Lesko LJ. Pharmacogenomics in drug development and regulatory decision-making: the Genomic data submission (GDS) proposal. Pharmacogenomics 2004;5:25-30.
16. Personalized Medicine: What is it? How Will it Affect Health Care? Felix W. Frueh, presented April 26, 2005 to the FDA Science Forum, Concepts and Tools in Pharmacogenomics, Pharmacogenomics from the Ground Up: Submissions and Labels in Regulatory Pharmacogenomics (http://www. fda. gov/cder/genomics/).
17. Lesko LJ, Woodcock J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nat Rev Drug Discovery 2004;3:763-769.
18. Salerno RA. Developing the regulatory pathway for pharmacogenomics. Regulatory Affairs Focus 2004;8:12-15.
19. Lesko LJ, Salerno RA, Spear BB, 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;34:342-358.
20. Salerno RA, Lesko LJ. Pharmacogenomic data: FDA Voluntary and Required Submission Guidance. Pharmacogenomics 2004;5:503-505.
21. Leighton JK, DeGeorge J, Jacobson-Kram D, MacGregor J, Mendrick D, Worobec A. Pharmacogenomic data submissions to FDA: non-clinical case studies. Pharmacogenomics 2004;5:507-511.
22. Gualberto R, Collins J, Dorner AJ, Wang SJ, Guerciolini R, Huang SM. Pharmacogenomic data submissions to FDA: clinical pharmacology case studies. Pharmacogenomics 2004;5:513-517.
23. Trepicchio WL, Williams GA, Essayan D, Hall ST, Harty LC, Shaw PM, Spear BB, Wang SJ, Watson ML. Pharmacogenomic data submissions to FDA: clinical case studies. Pharmacogenomics 2004;5:519-524.
24. Salerno RA, Lesko LJ. 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 2006;6:1-4.
25. Wang SJ, Cohen N, Katz DA, et al. Retrospective validation of genomic biomarkers-What are the questions, challenges and strategies for developing useful relationships to clinical outcomes-workshop summary. Pharmacogenomics J. 2006;6:82-8.
26. Trepicchio WL, Essayan D, Hall ST, et al. Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making. Pharmacogenomics J. 2006;6:89-94.
27. Tezak Z, Hackett J. Biomarker-based diagnostic devices in therapeutic applications (Marketed therapeutics). In Wong SHY, Linder M, Valdes R, Jr, ed. Pharmacogenomics and Proteomics: Enabling the Practice of Personalized Medicine. AACC Press, Washington, D. C. 2006, pp. 37-40.
28. Goodsaid F, Huang S-M, Frueh F, Temple R, Lesko JJ. Regulatory guidance and application of genomic biomarkers in drug development. In Wong SHY, Linder M, Valdes R, Jr, ed. Pharmacogenomics and Proteomics: Enabling the Practice of Personalized Medicine. AACC Press, Washington, D. C. 2006, pp. 41-52.
29. Feigal EG, Cossman J, Woosley RL. Clearing road blocks on critical path. Drug Discovery and Development 2006;9:28-34.
30. Gurwitz D, Lunshof JE, Dedoussis D, Flordellis CS, Fuhr U, Kirchheiner J, Licinio J, Llerena L, Manolopoulos VG, Sheffield LJ, Siest G, Torricelli FT, Vasiliou V, Wong S. Pharmacogenomics education: International Society of Pharmacogenomics Recommendations for Medical, Pharmaceutical, and Health Schools Deans of Education. Pharmacogenomics J 2005;5:221-225.
31. Valdes R Jr, Payne D, Linder MW, et al. Guidelines and recommendations for Laboratory analysis and application of pharmacogenetics to clinical practice (National Academy of Clinical Biochemistry). http://www. nacb. org/lmpg/LMPG-Pharmacogenetics. pdf.
32. Bertillsson L, Lou YW, Du YL, et al. Pronounced differences between Chinese and Swedish populations n the polymorphic hydroxylations of debrisoquin and S-mephenytoin. Clin Pharmacol Ther 1992;51:388-397.
33. Linder MW, Valdes R, Jr. Fundamentals and applications of pharmacogenetics for the clinical laboratory. Ann Clin Lab Sci 1999;29:140-149.
34. Wong SHY, Jannetto PJ. Pharmacogenomics. In Wu A, ed. Tietz's Applied Laboratory Medicine, 4th edition. Saunders Elsevier, St. Louis, 2006, pp. 1713-1742.
35. Rieder MJ, Reiner AP, Gage BF, Nickerson DA, Eby CS, McLeod HL, Blough DK, Thummel KE, Veenstra DL, Rettie AE. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N Engl J Med 2005;352:2285-2293.
36. O'Kane DJ. Use of PG in routine medical care. 3rd FDA-DIA Worksop, Bethesda, MD, April 13, 2005.
37. Payne D. Pharmacogenetic testing: how to choose a method to analyze genetic changes. Clin Lab News 2006;7:14-16.
38. Jannetto PJ, Laleli-Sahin E, Schur BC, Wong SH. Enabling pharmacogenomics: methodologies for genotyping. In Wong SHY, Linder MW, Valdes R, Jr., ed. Pharmacogenomics and Proteomics-Enabling the Practice of Personalized Medicine. AACC Press, Washington, D. C., 2006, pp. 1-386.
39. Weber WW. Techniques for analyzing pharmacogenetic variation. In Wong SHY, Linder MW, Valdes R, Jr, ed. Pharmacogenomics and Proteomics-Enabling the Practice of Personalized Medicine. AACC Press, Washington, D. C., 2006, pp. 1-386.
40. Higashi MK, Veenstra DL, Kondo LM, Wittkowsky AK, Srinouanaprachanh SL, Farin FM, Rettie AE. Association between CYP 2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. JAMA 2002;287(13):1690-1698.
41. Sconce EA, Kahn TI, Wynne HA, et al. The impact of CYP 2D9 and VKORC1 genetic polymorphism and patient characteristics on warfarin dose requirements: proposal for a new dose regimen. Blood 2005;106:2329-2333.
42. Marsh S, McLeod HL. Pharmacogenomics: from bedside to clinical practice. Hum Mol Genet 2006;15:R89-R93.
43. Rivory LP, Bowles MR, Robert J, et al. Conversion of irinotecan (CPT-11) to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38), by human liver carboxylesterase. Biochem Pharmacol 1996;52:1103-1111.
44. Iyer L, Hall D, Das S, et al. Phenotype-genotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1) promoter polymorphism. Clin Pharmacol Ther 1999;65:576-582.
45. Araki E, Ishikawa M, Iigo M, et al. Relationship between development of diarrhea and the concentration of SN-38, an active metabolite of CPT-11, in the intestine and the blood plasma of athymic mice following intraperitoneal administration of CPT-11. Jpn J Cancer Res 1993;84: 697-702.
46. Iyer L, Das S, Janisch L, et al. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenetics J 2002;2:43-47.