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Volumn 92, Issue 4, 2012, Pages 486-493

Advancing the science of medicines regulation: The role of the 21st-century medicines regulator

Author keywords

[No Author keywords available]

Indexed keywords

DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SAFETY; DRUG TOLERANCE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HUMAN; LEGAL ASPECT; MEDICINE REGULATION; PRIORITY JOURNAL; PUBLIC HEALTH; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SCIENCE;

EID: 84866623189     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2012.146     Document Type: Review
Times cited : (24)

References (27)
  • 1
    • 79959416954 scopus 로고    scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. Advancing Regulatory Science for Public Health http://www.fda.gov/downloads/ScienceResearch/Specialtopics/Regulatory Science/UcM228444.pdf (2010).
    • (2010) Advancing Regulatory Science for Public Health
  • 4
    • 84872219250 scopus 로고    scopus 로고
    • 16 March 2011
    • http://www. ema.europa.eu/ema/index.jsp?curl=pages/includes/document/ document-detail.jsp?webcontentId=Wc500103621 & mid=Wc0b01ac058009a3dc (16 March 2011).
  • 5
    • 1542333321 scopus 로고    scopus 로고
    • US Food and Drug Administration March 2005
    • US Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions http://www.fda.gov/downloads/Drugs/ GuidancecomplianceRegulatoryInformation/Guidances/UcM079849.pdf (March 2005)
    • Guidance for Industry: Pharmacogenomic Data Submissions
  • 8
    • 84872220932 scopus 로고    scopus 로고
    • US Food and Drug Administration 5 March 2012
    • US Food and Drug Administration. Biomarker Qualifcation Program http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugDevelopmenttoolsQualifcationProgram/ucm284076.htm (5 March 2012).
    • Biomarker Qualifcation Program
  • 9
    • 84872221227 scopus 로고    scopus 로고
    • US Food and Drug Administration 14 April 2008
    • US Food and Drug Administration. Letter from Janet Woodcock and John Jenkins to Frank Dieterle et al. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DrugDevelopmenttoolsQualifcationProgram/UcM285031. pdf (14 April 2008).
    • Letter from Janet Woodcock and John Jenkins to Frank Dieterle et Al
  • 11
    • 84855631700 scopus 로고    scopus 로고
    • US Food and Drug Administration 11 November 2010
    • US Food and Drug Administration. Predictive Safety testing consortium (PStc) http://www.fda.gov/AboutFDA/Partnershipscollaborations/ PublicPrivatePartnershipProgram/ucm231132.htm (11 November 2010).
    • Predictive Safety Testing Consortium (PStc)
  • 12
    • 50449104247 scopus 로고    scopus 로고
    • Developing new drugs for the treatment of drug-resistant tuberculosis: A regulatory perspective
    • Sacks, L.V. & Behrman, R.E. Developing new drugs for the treatment of drug-resistant tuberculosis: a regulatory perspective. Tuberculosis 99 (suppl. 1), S93-100 (2008).
    • (2008) Tuberculosis , vol.99 , Issue.SUPPL. 1
    • Sacks, L.V.1    Behrman, R.E.2
  • 13
    • 84872206042 scopus 로고    scopus 로고
    • Critical Path Institute. critical Path to tB Drug Regimens (cPtR)
    • Critical Path Institute. critical Path to tB Drug Regimens (cPtR) http://www.c-path.org/cPtR.cfm.
  • 17
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: Taking the next step in the evolution of drug approval
    • Eichler, H.G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426-437 (2012).
    • (2012) Clin. Pharmacol. Ther. , vol.91 , pp. 426-437
    • Eichler, H.G.1
  • 19
    • 77952819564 scopus 로고    scopus 로고
    • Validation of statistical signal detection procedures in EudraVigilance post-authorization data: A retrospective evaluation of the potential for earlier signalling
    • Alvarez, Y., Hidalgo, A., Maignen, F. & Slattery, J. Validation of statistical signal detection procedures in EudraVigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling. Drug Saf. 33, 475-487 (2010).
    • (2010) Drug Saf , vol.33 , pp. 475-487
    • Alvarez, Y.1    Hidalgo, A.2    Maignen, F.3    Slattery, J.4
  • 22
    • 84872215550 scopus 로고    scopus 로고
    • ENcePP: Where are we and where are we going?
    • 16 June 2011
    • Smeraldi, C. ENcePP: Where Are We and Where are We Going? European Medicines Agency http://www.ema.europa.eu/docs/en-GB/document-library/ Presentation/2011/11/Wc500117945.pdf (16 June 2011).
    • European Medicines Agency
    • Smeraldi, C.1
  • 25
    • 84857237851 scopus 로고    scopus 로고
    • The innovative medicines initiative: A European response to the innovation challenge
    • Goldman, M. the innovative medicines initiative: a European response to the innovation challenge. Clin. Pharmacol. Ther. 91, 418-425 (2012).
    • (2012) Clin. Pharmacol. Ther. , vol.91 , pp. 418-425
    • Goldman, M.1
  • 26
    • 39649084919 scopus 로고    scopus 로고
    • The FDA critical path initiative and its infuence on new drug development
    • Woodcock, J. & Woosley, R. the FDA critical path initiative and its infuence on new drug development. Annu. Rev. Med. 59, 1-12 (2008).
    • (2008) Annu. Rev. Med. , vol.59 , pp. 1-12
    • Woodcock, J.1    Woosley, R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.