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Volumn 28, Issue 5, 2010, Pages 441-443

Evolution of biomarker qualification at the health authorities

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

EID: 77952175271     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt0510-441     Document Type: Note
Times cited : (45)

References (19)
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    • The Food and Drug Administration FDA, Rockville, Maryland, USA, March accessed 8 September 2009
    • The Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions (FDA, Rockville, Maryland, USA, March 2005; accessed 8 September 2009). http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm079849.pdf
    • (2005) Guidance for Industry: Pharmacogenomic Data Submissions
  • 3
    • 77952130923 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medical Products EMEA, London, UK, accessed 8 September
    • European Agency for the Evaluation of Medical Products. Medicines and Emerging Science (EMEA, London, UK, accessed 8 September 2009) http://www.emea.europa.eu/htms/human/mes/emergingtechnologies.htm
    • (2009) Medicines and Emerging Science
  • 4
    • 77952152364 scopus 로고    scopus 로고
    • The Food and Drug Administration
    • The Food and Drug Administration. Fed. Reg. 69, 48876-48877 (2004). http://www.fda.gov/OHRMS/DOCKETS/98fr/04-18360.htm
    • (2004) Fed. Reg. , vol.69 , pp. 48876-48877
  • 5
    • 77952155976 scopus 로고    scopus 로고
    • The European Medicines Agency EMEA, London, UK 2004; accessed 8 September 2009
    • The European Medicines Agency. EMEA/CHMP/PGxWP/20227/04 Guideline on Pharmacognetics Briefing Meetings (EMEA, London, UK 2004; accessed 8 September 2009). http://www.ema.europa.eu/pdfs/human/pharmacogenetics/2022704en.pdf
    • EMEA/CHMP/PGxWP/20227/04 Guideline on Pharmacognetics Briefing Meetings
  • 7
    • 74549144459 scopus 로고    scopus 로고
    • The Food and Drug Administration FDA, Rockville, Maryland, USA
    • The Food and Drug Administration. Critical Path Initiative (FDA, Rockville, Maryland, USA, (2004)
    • (2004) Critical Path Initiative
  • 8
    • 77952134538 scopus 로고    scopus 로고
    • http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ default.htm
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    • 77952191647 scopus 로고    scopus 로고
    • The Food and Drug Administration accessed 8 September 2009
    • The Food and Drug Administration. Fed. Reg. 69, 42060-42061 (2004; accessed 8 September 2009). http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15935.htm
    • (2004) Fed. Reg. , vol.69 , pp. 42060-42061
  • 18
    • 77952216513 scopus 로고    scopus 로고
    • The Food and Drug Administration FDA, Rockville, Maryland, USA; accessed 8 September 2009
    • The Food and Drug Administration. Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels (FDA, Rockville, Maryland, USA; accessed 8 September 2009). http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ Pharmacogenetics/ucm083378.htm.
    • Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels
  • 19
    • 77952159432 scopus 로고    scopus 로고
    • The European Medicines Agency EMEA, London, UK, January accessed 8 September 2009
    • The European Medicines Agency. Guidance Document on the Qualification of Novel Methodologies for Drug Development (EMEA, London, UK, January 2009; accessed 8 September 2009). http://www.ema.europa. eu/pdfs/human/biomarkers/ 7289408en.pdf
    • (2009) Guidance Document on the Qualification of Novel Methodologies for Drug Development


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.