메뉴 건너뛰기




Volumn 63, Issue 3, 2006, Pages 301-326

Regulatory perspectives on pharmacogenomics: A review of the literature on key issues faced by the United States Food and Drug Administration

Author keywords

Genetics; Government industry relationships; Health technologies; Pharmacogenomics; Regulation

Indexed keywords

DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GENETIC ANALYSIS; HUMAN GENOME PROJECT; MEDICAL TECHNOLOGY; PHARMACOGENOMICS; PRACTICE GUIDELINE; PUBLIC HEALTH; REVIEW; RISK BENEFIT ANALYSIS; SAFETY; UNITED STATES;

EID: 33646371252     PISSN: 10775587     EISSN: 15526801     Source Type: Journal    
DOI: 10.1177/1077558706287020     Document Type: Review
Times cited : (23)

References (118)
  • 1
    • 0242363251 scopus 로고    scopus 로고
    • With your genes? Take one of these, three times a day
    • Abbott, A. 2003. With your genes? Take one of these, three times a day. Nature 425:760-62.
    • (2003) Nature , vol.425 , pp. 760-762
    • Abbott, A.1
  • 2
    • 0037238861 scopus 로고    scopus 로고
    • Adverse drug event monitoring at the Food and Drug Administration: Your report can make a difference
    • Ahmad, S. R. 2003. Adverse drug event monitoring at the Food and Drug Administration: Your report can make a difference. Journal of General Internal Medicine 18:57-60.
    • (2003) Journal of General Internal Medicine , vol.18 , pp. 57-60
    • Ahmad, S.R.1
  • 4
    • 0038415833 scopus 로고    scopus 로고
    • How pharmacogenomics will impact the federal regulation of clinical trials and the new drug approval process
    • Binzak, B. A. 2003. How pharmacogenomics will impact the federal regulation of clinical trials and the new drug approval process. Food and Drug Law Journal 58 (1): 103-27.
    • (2003) Food and Drug Law Journal , vol.58 , Issue.1 , pp. 103-127
    • Binzak, B.A.1
  • 6
    • 33646364475 scopus 로고    scopus 로고
    • Bio-IT World June 12, 2002
    • Branca, M. 2002. FDA fosters pharmacogenomics. Bio-IT World June 12, 2002. http:// www.bio-itworld.com/archive/061202/horizons_lesko.html (accessed January 7, 2004).
    • (2002) FDA Fosters Pharmacogenomics
    • Branca, M.1
  • 7
    • 0036119713 scopus 로고    scopus 로고
    • Maximizing the value of medicines by including pharmacogenetic research in drug development and surveillance
    • Brazell, C., A. Freeman, and M. Mosteller. 2002. Maximizing the value of medicines by including pharmacogenetic research in drug development and surveillance. British Journal of Clinical Pharmacology 53:224-31.
    • (2002) British Journal of Clinical Pharmacology , vol.53 , pp. 224-231
    • Brazell, C.1    Freeman, A.2    Mosteller, M.3
  • 9
    • 0036373109 scopus 로고    scopus 로고
    • A regulatory protocol for pharmacogenomics services
    • Bristol, L. A. 2002. A regulatory protocol for pharmacogenomics services. Pharmacogenomics Journal 2:83-86.
    • (2002) Pharmacogenomics Journal , vol.2 , pp. 83-86
    • Bristol, L.A.1
  • 11
    • 0042734800 scopus 로고    scopus 로고
    • The "GeneTrustee": A universal identification system that ensures privacy and confidentiality for human genetic databases
    • Burnett, L., K. Barlow-Stewart, A. L. Proos, and H. Aizenberg. 2003. The "GeneTrustee": A universal identification system that ensures privacy and confidentiality for human genetic databases. Journal of Law and Medicine 10 (4): 506-13.
    • (2003) Journal of Law and Medicine , vol.10 , Issue.4 , pp. 506-513
    • Burnett, L.1    Barlow-Stewart, K.2    Proos, A.L.3    Aizenberg, H.4
  • 12
    • 4243202808 scopus 로고    scopus 로고
    • The political economy of FDA drug review: Processing, politics, and lessons for policy
    • Carpenter, D. P. 2004. The political economy of FDA drug review: Processing, politics, and lessons for policy. Health Affairs (Millwood) 23 (1): 52-63.
    • (2004) Health Affairs (Millwood) , vol.23 , Issue.1 , pp. 52-63
    • Carpenter, D.P.1
  • 15
    • 0036168320 scopus 로고    scopus 로고
    • The economics of gene therapy and of pharmacogenetics
    • Danzon, P., and A. Towse. 2002. The economics of gene therapy and of pharmacogenetics. Value Health 5 (1): 5-13.
    • (2002) Value Health , vol.5 , Issue.1 , pp. 5-13
    • Danzon, P.1    Towse, A.2
  • 16
    • 0036450511 scopus 로고    scopus 로고
    • Pharmacogenetics research network and knowledge base second scientific meeting
    • Davis, A. F., and R. M. Long. 2002. Pharmacogenetics research network and knowledge base second scientific meeting. Pharmacogenomics Journal 2:293-96.
    • (2002) Pharmacogenomics Journal , vol.2 , pp. 293-296
    • Davis, A.F.1    Long, R.M.2
  • 19
    • 0036900176 scopus 로고    scopus 로고
    • What's brewing in genetic testing?
    • Editorial
    • Editorial. 2002. What's brewing in genetic testing? Nature Genetics 32 (4): 553-54.
    • (2002) Nature Genetics , vol.32 , Issue.4 , pp. 553-554
  • 20
    • 0037327533 scopus 로고    scopus 로고
    • Getting a grip on genetic testing?
    • _. 2003. Getting a grip on genetic testing? Nature Medicine 9 (2): 147.
    • (2003) Nature Medicine , vol.9 , Issue.2 , pp. 147
  • 21
    • 0036739552 scopus 로고    scopus 로고
    • Will pharmacogenomics alter the role of patents in drug development?
    • Eisenberg, R. S. 2003. Will pharmacogenomics alter the role of patents in drug development? Pharmacogenomics 3 (5): 571-74.
    • (2003) Pharmacogenomics , vol.3 , Issue.5 , pp. 571-574
    • Eisenberg, R.S.1
  • 22
    • 2642570170 scopus 로고    scopus 로고
    • Moving towards individualized medicine with pharmacogenomics
    • Evans, W. E., and M. K. Relling. 2004. Moving towards individualized medicine with pharmacogenomics. Nature 429:464-68.
    • (2004) Nature , vol.429 , pp. 464-468
    • Evans, W.E.1    Relling, M.K.2
  • 23
    • 33646350931 scopus 로고    scopus 로고
    • Science Board to the Food and Drug Administration
    • FDA Science Board. 2004. Science Board to the Food and Drug Administration. http://www.fda.gov/oc/advisory/sci.html (accessed March 30, 2004).
    • (2004)
  • 24
    • 33646352367 scopus 로고    scopus 로고
    • FDA Pharmacogenomics Advisory Committee will oversee data submission
    • March 22, 2004
    • FDC Reports. 2004. FDA Pharmacogenomics Advisory Committee will oversee data submission. The Pink Sheet, March 22, 2004.
    • (2004) The Pink Sheet
  • 25
    • 33646364215 scopus 로고    scopus 로고
    • Drug development too risky without pharmacogenomics, McClellan says
    • Special reprint for Gennaissance Pharmaceuticals, Inc. November 17, 2003
    • FDC Reports Inc. 2003. Drug development too risky without pharmacogenomics, McClellan says. Special reprint for Gennaissance Pharmaceuticals, Inc. In The Pink Sheet, November 17, 2003. http://www.genaissance.com/aboutus/news/p031117a. pdf (accessed December 3, 2003).
    • (2003) The Pink Sheet
  • 26
    • 0141711167 scopus 로고    scopus 로고
    • Drug development, regulation, and genetically guided therapy
    • edited by M. A. Rothstein. Hoboken, NJ: John Wiley
    • Feigal, D. W., and S. Gutman. 2003. Drug development, regulation, and genetically guided therapy. In Pharmacogenomics: Social, ethical, and clinical dimensions, edited by M. A. Rothstein. Hoboken, NJ: John Wiley.
    • (2003) Pharmacogenomics: Social, Ethical, and Clinical Dimensions
    • Feigal, D.W.1    Gutman, S.2
  • 27
    • 0038004636 scopus 로고    scopus 로고
    • Clinical biomarkers in drug discovery and development
    • Frank, R., and R. Hargreaves. 2003. Clinical biomarkers in drug discovery and development. Nature Reviews: Drug Discovery 2:566-80.
    • (2003) Nature Reviews: Drug Discovery , vol.2 , pp. 566-580
    • Frank, R.1    Hargreaves, R.2
  • 28
    • 4444326242 scopus 로고    scopus 로고
    • Toxicogenomics data: The road to acceptance
    • Freeman, K. 2004. Toxicogenomics data: The road to acceptance. Environmental Health Perspectives 112 (12): A678-85.
    • (2004) Environmental Health Perspectives , vol.112 , Issue.12
    • Freeman, K.1
  • 29
    • 3242770351 scopus 로고    scopus 로고
    • Roche test promises to tailor drugs to patients
    • June 25
    • Fuhrmans, V. 2003. Roche test promises to tailor drugs to patients. Wall Street Journal, June 25, A3.
    • (2003) Wall Street Journal
    • Fuhrmans, V.1
  • 30
    • 0036358094 scopus 로고    scopus 로고
    • Coding for change: The power of the human genome to transfer the American health insurance system
    • Geetter, J. S. 2002. Coding for change: The power of the human genome to transfer the American health insurance system. American Journal of Law & Medicine 28: 1-76.
    • (2002) American Journal of Law & Medicine , vol.28 , pp. 1-76
    • Geetter, J.S.1
  • 32
    • 0037048668 scopus 로고    scopus 로고
    • Limitations of direct-to-consumer advertising for clinical genetic testing
    • Gollust, S. E., S. C. Hull, and B. S. Wilfond. 2002. Limitations of direct-to-consumer advertising for clinical genetic testing. Journal of the American Medical Association 288 (14): 1762-67.
    • (2002) Journal of the American Medical Association , vol.288 , Issue.14 , pp. 1762-1767
    • Gollust, S.E.1    Hull, S.C.2    Wilfond, B.S.3
  • 33
    • 0032896624 scopus 로고    scopus 로고
    • The role of Food and Drug Administration regulation of in vitro diagnostic devices - Applications to genetics testing
    • Gutman, S. 1999. The role of Food and Drug Administration regulation of in vitro diagnostic devices - Applications to genetics testing. Clinical Chemistry 45 (5): 746-49.
    • (1999) Clinical Chemistry , vol.45 , Issue.5 , pp. 746-749
    • Gutman, S.1
  • 34
    • 33646371622 scopus 로고    scopus 로고
    • FDA's oversight of labeling, advertising and marketing of genetic tests
    • Paper presented, October 22, Washington, DC
    • _. 2003. FDA's oversight of labeling, advertising and marketing of genetic tests. Paper presented at the meeting of the Secretary's Advisory Committee on Genetics Health and Society, October 22, Washington, DC.
    • (2003) Meeting of the Secretary's Advisory Committee on Genetics Health and Society
  • 36
    • 0038392396 scopus 로고    scopus 로고
    • Microarray data - The US FDA, industry and academia
    • Hackett, J. L., and L. J. Lesko. 2003. Microarray data - The US FDA, industry and academia. Nature Biotechnology 21 (7): 742-43.
    • (2003) Nature Biotechnology , vol.21 , Issue.7 , pp. 742-743
    • Hackett, J.L.1    Lesko, L.J.2
  • 38
    • 0033569415 scopus 로고    scopus 로고
    • Are genetic tests adequately regulated?
    • Holtzman, N. A. 1999. Are genetic tests adequately regulated? Science 286:409.
    • (1999) Science , vol.286 , pp. 409
    • Holtzman, N.A.1
  • 39
    • 0031682611 scopus 로고    scopus 로고
    • FDA regulation of genetic testing: Institutional reluctance and public guardianship
    • Huang, A. 1998. FDA regulation of genetic testing: Institutional reluctance and public guardianship. Food and Drug Law Journal 53 (3): 555-91.
    • (1998) Food and Drug Law Journal , vol.53 , Issue.3 , pp. 555-591
    • Huang, A.1
  • 40
    • 0036527287 scopus 로고    scopus 로고
    • Ethical perspectives on pharmacogenomic profiling in the drug development process
    • Issa, A.M. 2002. Ethical perspectives on pharmacogenomic profiling in the drug development process. Nature Reviews: Drug Discovery 1:300-308.
    • (2002) Nature Reviews: Drug Discovery , vol.1 , pp. 300-308
    • Issa, A.M.1
  • 41
    • 0141851357 scopus 로고    scopus 로고
    • Pharmacogenomic profiling in postmarketing surveillance: Prospects and challenges
    • _. 2003. Pharmacogenomic profiling in postmarketing surveillance: Prospects and challenges. Pharmacogenomics 4 (5): 647-55.
    • (2003) Pharmacogenomics , vol.4 , Issue.5 , pp. 647-655
  • 42
    • 4544253924 scopus 로고    scopus 로고
    • The regulation of pharmacogenomics-based drugs and policy making
    • _. 2004. The regulation of pharmacogenomics-based drugs and policy making. Current Topics in Medicinal Chemistry 4 (13): 1455-60.
    • (2004) Current Topics in Medicinal Chemistry , vol.4 , Issue.13 , pp. 1455-1460
  • 45
    • 33646351457 scopus 로고    scopus 로고
    • Impact of pharmacogenomics on FDA's drug review process
    • Paper presented, October 22, Washington, DC
    • _. 2003b. Impact of pharmacogenomics on FDA's drug review process. Paper presented at the meeting of the Secretary's Advisory Committee on Genetics Health and Society, October 22, Washington, DC.
    • (2003) Meeting of the Secretary's Advisory Committee on Genetics Health and Society
  • 47
    • 33646344390 scopus 로고    scopus 로고
    • Sponsored by the FDA and companies represented on the Pharmaceutical Research Manufacturers of America (PhRMA) Preclinical Safety Committee (DruSafe), and the Pharmacogenetics Working Group (PWG)
    • Lesko, L. J., and R. A. Salerno. 2002. 2002 Workshop on pharmacogenetics/ pharmacogenomics in drug development and regulalatory decision-making. Sponsored by the FDA and companies represented on the Pharmaceutical Research Manufacturers of America (PhRMA) Preclinical Safety Committee (DruSafe), and the Pharmacogenetics Working Group (PWG). http://www.fda.gov.
    • (2002) 2002 Workshop on Pharmacogenetics/ Pharmacogenomics in Drug Development and Regulalatory Decision-making
    • Lesko, L.J.1    Salerno, R.A.2
  • 48
    • 0037380651 scopus 로고    scopus 로고
    • Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PWG-PhRMA-DruSafe Workshop
    • Lesko, L. J., R. A. Salerno, B. B. Spear, D. C. Anderson, T. Anderson, C. Brazell, J. Collins, et al. 2003. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PWG-PhRMA-DruSafe Workshop. Journal of Clinical Pharmacology 43:342-58.
    • (2003) Journal of Clinical Pharmacology , vol.43 , pp. 342-358
    • Lesko, L.J.1    Salerno, R.A.2    Spear, B.B.3    Anderson, D.C.4    Anderson, T.5    Brazell, C.6    Collins, J.7
  • 49
    • 0036367324 scopus 로고    scopus 로고
    • Pharmacogenomic-guided drug development: Regulatory perspective
    • Lesko, L. J., and J. Woodcock. 2002. Pharmacogenomic-guided drug development: Regulatory perspective. Pharmacogenomics Journal 2 (1): 20-24.
    • (2002) Pharmacogenomics Journal , vol.2 , Issue.1 , pp. 20-24
    • Lesko, L.J.1    Woodcock, J.2
  • 50
    • 4544335467 scopus 로고    scopus 로고
    • Translation of pharmacogenomics and pharmacogenetics: A regulatory perspective
    • _. 2004. Translation of pharmacogenomics and pharmacogenetics: A regulatory perspective. Nature Reviews: Drug Discovery 3:763-69.
    • (2004) Nature Reviews: Drug Discovery , vol.3 , pp. 763-769
  • 51
    • 0037505780 scopus 로고    scopus 로고
    • The impact of direct-to-consumer advertising
    • March-April
    • Lewis, C. 2003. The impact of direct-to-consumer advertising. FDA Consumer Magazine, March-April.
    • (2003) FDA Consumer Magazine
    • Lewis, C.1
  • 52
    • 0037362038 scopus 로고    scopus 로고
    • Pharmacogenetics and the future of medical practice
    • Lindpaintner, K. 2003. Pharmacogenetics and the future of medical practice. Journal of Molecular Medicine 81 (3): 141-53.
    • (2003) Journal of Molecular Medicine , vol.81 , Issue.3 , pp. 141-153
    • Lindpaintner, K.1
  • 56
    • 0142240380 scopus 로고    scopus 로고
    • Preventing toxicity with a gene test
    • Marshall, E. 2003. Preventing toxicity with a gene test. Science 302:588-90.
    • (2003) Science , vol.302 , pp. 588-590
    • Marshall, E.1
  • 58
    • 0242643719 scopus 로고    scopus 로고
    • Pharmacogenetics and public policy: Expert views in Europe and North America
    • Melzer, D., D. Detmer, and R. Zimmern. 2003. Pharmacogenetics and public policy: Expert views in Europe and North America. Pharmacogenomics 4 (6): 1-3.
    • (2003) Pharmacogenomics , vol.4 , Issue.6 , pp. 1-3
    • Melzer, D.1    Detmer, D.2    Zimmern, R.3
  • 60
    • 0141516711 scopus 로고    scopus 로고
    • Regulatory options for pharmacogenetics
    • Melzer, D., R. L. Zimmern, and T. Ling. 2003. Regulatory options for pharmacogenetics. Pharmacogenomics 4 (5): 527-30.
    • (2003) Pharmacogenomics , vol.4 , Issue.5 , pp. 527-530
    • Melzer, D.1    Zimmern, R.L.2    Ling, T.3
  • 62
    • 33646357655 scopus 로고    scopus 로고
    • Noted on NCCLS Web site
    • National Committee for Clinical Laboratory Standards. 2004. Determining clinical utility of genetic tests. Noted on NCCLS Web site. http://www.nccls.org/Content/ NavigationMenu/Standards_Development/NCCLS_Standards_Development/ Committees_and_Projects/Area_Committee_on_Molecular_Methods/Projects_ in_Development8/Projects_in_Development.htm.
    • (2004) Determining Clinical Utility of Genetic Tests
  • 63
    • 0345920900 scopus 로고    scopus 로고
    • Nuffield Council on Bioethics. 2003. Pharmacogenetics: Ethical issues. http://www. nuffieldbioethics.org (accessed October 25, 2003).
    • (2003) Pharmacogenetics: Ethical Issues
  • 64
    • 0034840086 scopus 로고    scopus 로고
    • 4th annual pharmacogenomics and medicine lectures
    • Oestreicher, P. 2001. 4th annual pharmacogenomics and medicine lectures. Pharmcogenomics 2 (3): 291-96.
    • (2001) Pharmcogenomics , vol.2 , Issue.3 , pp. 291-296
    • Oestreicher, P.1
  • 65
    • 0043101954 scopus 로고    scopus 로고
    • At-home DNA tests are here
    • June 25
    • Pearson, H. 2002. At-home DNA tests are here. Wall Street Journal, June 25, D6.
    • (2002) Wall Street Journal
    • Pearson, H.1
  • 67
    • 28644448646 scopus 로고    scopus 로고
    • Terminology for sample collection in clinical genetic studies
    • Pharmacogenetics Working Group. 2001. Terminology for sample collection in clinical genetic studies. Pharmacogenomics Journal 1:101-3.
    • (2001) Pharmacogenomics Journal , vol.1 , pp. 101-103
  • 69
    • 11044228905 scopus 로고    scopus 로고
    • Cost-effectiveness of pharmacogenomic interventions: A systematic review of the literature
    • Phillips, K. A., and S. L. Van Bebber. 2004. Cost-effectiveness of pharmacogenomic interventions: A systematic review of the literature. Pharmacogenomics 5 (8): 1139-49.
    • (2004) Pharmacogenomics , vol.5 , Issue.8 , pp. 1139-1149
    • Phillips, K.A.1    Van Bebber, S.L.2
  • 70
    • 33646352130 scopus 로고    scopus 로고
    • Where could genetic testing to individualize drug therapies have the greatest impact? the example of genetic testing for CYP2D6 variant alleles
    • _. 2005. Where could genetic testing to individualize drug therapies have the greatest impact? The example of genetic testing for CYP2D6 variant alleles. Nature Reviews: Drug Discovery 4 (6): 500-509.
    • (2005) Nature Reviews: Drug Discovery , vol.4 , Issue.6 , pp. 500-509
  • 73
    • 0038745780 scopus 로고    scopus 로고
    • An introduction to cost-effectiveness and cost-benefit analysis of pharmacogenomics
    • Phillips, K. A., D. Veenstra, S. L. Van Bebber, and J. Sakowski. 2003. An introduction to cost-effectiveness and cost-benefit analysis of pharmacogenomics. Pharmacogenomics 4 (3): 231-39.
    • (2003) Pharmacogenomics , vol.4 , Issue.3 , pp. 231-239
    • Phillips, K.A.1    Veenstra, D.2    Van Bebber, S.L.3    Sakowski, J.4
  • 75
    • 3242743707 scopus 로고    scopus 로고
    • Genetic testing and pharmacogenomics: Issues for determining the impact to health care delivery and costs
    • Phillips, K. A., D. L. Veenstra, S. D. Ramsey, S. L. Van Bebber, and J. Sakowski. 2004. Genetic testing and pharmacogenomics: Issues for determining the impact to health care delivery and costs. American Journal of Managed Care 10 (7): 425-32.
    • (2004) American Journal of Managed Care , vol.10 , Issue.7 , pp. 425-432
    • Phillips, K.A.1    Veenstra, D.L.2    Ramsey, S.D.3    Van Bebber, S.L.4    Sakowski, J.5
  • 76
    • 0011999969 scopus 로고    scopus 로고
    • Implications of the genetics revolution for health services research: Pharmacogenomics and improvements in drug therapy
    • Phillips, K. A., D. L. Veenstra, and W. Sadee. 2000. Implications of the genetics revolution for health services research: Pharmacogenomics and improvements in drug therapy. Health Services Research 35 (5): 1-12.
    • (2000) Health Services Research , vol.35 , Issue.5 , pp. 1-12
    • Phillips, K.A.1    Veenstra, D.L.2    Sadee, W.3
  • 78
    • 33646361481 scopus 로고    scopus 로고
    • Update on FDA's pediatric labeling regulations and initiatives on patient drug information
    • Paper presented, June 14
    • Raczkowski, V. F. C. 2000. Update on FDA's pediatric labeling regulations and initiatives on patient drug information. Paper presented at the annual meeting of the Drug Information Association, June 14. http://www.fda.gov/cder/present/dia-62000/ vicrac2/index.htm (accessed January 22, 2004).
    • (2000) Annual Meeting of the Drug Information Association
    • Raczkowski, V.F.C.1
  • 80
    • 0034940965 scopus 로고    scopus 로고
    • Consent and privacy in pharmacogenetic testing
    • Robertson, J. A. 2001. Consent and privacy in pharmacogenetic testing. Nature Genetics 28 (3): 207-9.
    • (2001) Nature Genetics , vol.28 , Issue.3 , pp. 207-209
    • Robertson, J.A.1
  • 83
    • 0034660560 scopus 로고    scopus 로고
    • Pharmacogenetics and the practice of medicine
    • Roses, A. D. 2000. Pharmacogenetics and the practice of medicine. Nature 405:857-65.
    • (2000) Nature , vol.405 , pp. 857-865
    • Roses, A.D.1
  • 84
    • 4344684441 scopus 로고    scopus 로고
    • Pharmacogenetics and drug development: The path to safer and more effective drugs
    • _. 2004. Pharmacogenetics and drug development: The path to safer and more effective drugs. Nature Reviews: Genetics 5 (9): 645-56.
    • (2004) Nature Reviews: Genetics , vol.5 , Issue.9 , pp. 645-656
  • 85
    • 0141516672 scopus 로고    scopus 로고
    • Microarray technology - An intellectual property retrospective
    • Rouse, R., and G. Hardiman. 2003. Microarray technology - An intellectual property retrospective. Pharmacogenomics 4 (5): 623-32.
    • (2003) Pharmacogenomics , vol.4 , Issue.5 , pp. 623-632
    • Rouse, R.1    Hardiman, G.2
  • 86
    • 0347136017 scopus 로고    scopus 로고
    • Pharmacogenomics in drug development and regulatory decision-making: The Genomic Data Submission (GDS) Proposal
    • Salerno, R. A., and L. J. Lesko. 2004. Pharmacogenomics in drug development and regulatory decision-making: The Genomic Data Submission (GDS) Proposal. Pharmacogenomics 5 (1): 25-30.
    • (2004) Pharmacogenomics , vol.5 , Issue.1 , pp. 25-30
    • Salerno, R.A.1    Lesko, L.J.2
  • 87
    • 0346958246 scopus 로고    scopus 로고
    • FDA guidance on pharmacogenomics data submission
    • Savage, D. R. 2003. FDA guidance on pharmacogenomics data submission. Nature Reviews Drug Discovery 2:937-38.
    • (2003) Nature Reviews Drug Discovery , vol.2 , pp. 937-938
    • Savage, D.R.1
  • 88
    • 0003445355 scopus 로고    scopus 로고
    • Bethesda: Secretary's Advisory Committee on Genetic Testing, National Institute of Health
    • Secretary's Advisory Committee on Genetic Testing. 2000a. Enhancing the oversight of genetic tests: Recommendations of the SACGT. Bethesda: Secretary's Advisory Committee on Genetic Testing, National Institute of Health.
    • (2000) Enhancing the Oversight of Genetic Tests: Recommendations of the SACGT
  • 90
    • 33646337565 scopus 로고    scopus 로고
    • Questions and answers with Wylie Burke and Nicholas Dracopoli
    • Paper presented, June 11-12, Washington, DC
    • Secretary's Advisory Committee on Genetics Health and Society. 2003a. Questions and answers with Wylie Burke and Nicholas Dracopoli. Paper presented at the inaugural SACGHS meeting, June 11-12, Washington, DC.
    • (2003) Inaugural SACGHS Meeting
  • 92
    • 0038730474 scopus 로고    scopus 로고
    • Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare
    • Shah, J. 2003. Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare. Nature Biotechnology 21 (7): 747-53.
    • (2003) Nature Biotechnology , vol.21 , Issue.7 , pp. 747-753
    • Shah, J.1
  • 96
    • 0002118734 scopus 로고    scopus 로고
    • Viewpoint - Pharmacogenomics: Today, tomorrow, and beyond
    • Spear, B. B. 1999. Viewpoint - Pharmacogenomics: Today, tomorrow, and beyond. Drug Benefit Trends 11 (2): 53-54.
    • (1999) Drug Benefit Trends , vol.11 , Issue.2 , pp. 53-54
    • Spear, B.B.1
  • 97
    • 33646367567 scopus 로고    scopus 로고
    • Paper presented to the FDA Science Board, April 9, 2003, Rockville, MD
    • _. 2003. Pharmacogenomics in drug development. Paper presented to the FDA Science Board, April 9, 2003, Rockville, MD. http://www.fda.gov/ohrms/dockets/ ac/03/slides/3944s1_08-Spear.ppt (accessed February 14, 2006).
    • (2003) Pharmacogenomics in Drug Development
  • 99
    • 0041669302 scopus 로고    scopus 로고
    • Beyond release: The equitable use of genetic information
    • Sulston, J. 2003. Beyond release: The equitable use of genetic information. The Lancet 362:400-401.
    • (2003) The Lancet , vol.362 , pp. 400-401
    • Sulston, J.1
  • 101
    • 0141739761 scopus 로고    scopus 로고
    • A reality check for molecular diagnostics in clinical practice
    • Tsongalis, G. J. 2003. A reality check for molecular diagnostics in clinical practice. Pharmacogenomics 4 (5): 667-68.
    • (2003) Pharmacogenomics , vol.4 , Issue.5 , pp. 667-668
    • Tsongalis, G.J.1
  • 102
    • 24844476276 scopus 로고
    • Health care technology in the United States
    • edited by U.S. Congress and Office of Health Technology Assessment. Washington, DC: Government Printing Office
    • Tunis, S. R., and H. Gelband. 1995. Health care technology in the United States. In Health care technology and its assessment in eight countries, edited by U.S. Congress and Office of Health Technology Assessment. Washington, DC: Government Printing Office.
    • (1995) Health Care Technology and Its Assessment in Eight Countries
    • Tunis, S.R.1    Gelband, H.2
  • 103
  • 106
    • 1542333321 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDER). 2005. Guidance for Industry: Pharmacogenomic data submissions. http://www. fda.gov/cder/guidance/6400fnl.pdf (accessed April 26, 2005).
    • (2005) Guidance for Industry: Pharmacogenomic Data Submissions
  • 109
    • 33646336515 scopus 로고    scopus 로고
    • FDA clears first of kind genetic lab test
    • _. 2004. FDA clears first of kind genetic lab test. FDA News. http://www.fda. gov/bbs/topics/news/2004/new01149.html (accessed December 23, 2004).
    • (2004) FDA News
  • 110
    • 0038783606 scopus 로고    scopus 로고
    • What is next in pharmacogenomics? Translating it to clinical practice
    • Valdes, R. M. W. Linder, and S. A. Jortani. 2003. What is next in pharmacogenomics? Translating it to clinical practice. Pharmacoeconomics 4 (4): 499-505.
    • (2003) Pharmacoeconomics , vol.4 , Issue.4 , pp. 499-505
    • Valdes, R.M.W.L.1    Jortani, S.A.2
  • 111
    • 0037038230 scopus 로고    scopus 로고
    • Getting ready for gene-based medicine
    • Varmus, H. 2002. Getting ready for gene-based medicine. New England Journal of Medicine 347 (19): 1526-27.
    • (2002) New England Journal of Medicine , vol.347 , Issue.19 , pp. 1526-1527
    • Varmus, H.1
  • 112
    • 18044400330 scopus 로고    scopus 로고
    • Assessing the cost-effectiveness of pharmacogenomics
    • September 14, 2 (3, article 29)
    • Veenstra, D. L., M. K. Higashi, and K. A. Phillips. 2000. Assessing the cost-effectiveness of pharmacogenomics. Pharmaceutical-Sciences, September 14, 2 (3, article 29). http:// www.aapspharmsci.org/view.asp?art=ps020329.
    • (2000) Pharmaceutical-Sciences
    • Veenstra, D.L.1    Higashi, M.K.2    Phillips, K.A.3
  • 113
    • 0141427964 scopus 로고    scopus 로고
    • From Genome Exploration to Drug Development
    • June 2003
    • Weshler, J. 2003. From Genome Exploration to Drug Development. Pharmaceutical Technology June 2003:26-34.
    • (2003) Pharmaceutical Technology , pp. 26-34
    • Weshler, J.1
  • 116
    • 33646348879 scopus 로고    scopus 로고
    • Direct to consumer advertising of prescription drugs: Exploring the consequences
    • July 22
    • Woodcock, J. 2003a. Direct to consumer advertising of prescription drugs: Exploring the consequences. Statement before the Senate Special Committee on Aging, July 22. http://www.fda.gov/ola/2003/AdvertisingofPrescriptionDrugs0722.html (accessed February 9,2004).
    • (2003) Statement before the Senate Special Committee on Aging
    • Woodcock, J.1
  • 117
    • 33646383255 scopus 로고    scopus 로고
    • Draft Guidance for Industry: Pharmacogenomic data submissions
    • Paper presented, November 13, Washington, DC
    • _. 2003b. Draft Guidance for Industry: Pharmacogenomic data submissions. Paper presented at Genomic Data Submission conference, November 13, Washington, DC.
    • (2003) Genomic Data Submission Conference
  • 118
    • 0346979306 scopus 로고    scopus 로고
    • Firms sell gene tests directly to public
    • August 11, 2002
    • Zitner, A. 2002. Firms sell gene tests directly to public. Los Angeles Times, August 11, 2002, A1.
    • (2002) Los Angeles Times
    • Zitner, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.