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Volumn 10, Issue 1, 2011, Pages 3-4

Evolution of regulatory frameworks

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONTRACEPTION; DATA BASE; DRUG DEVELOPMENT; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; LAW; MEDICINE; NOTE; POLICY; PRIORITY JOURNAL; PUBLIC HEALTH; TECHNOLOGY; UNITED STATES; VENOUS THROMBOEMBOLISM;

EID: 78650819372     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3348     Document Type: Note
Times cited : (13)

References (6)
  • 1
    • 76949104143 scopus 로고    scopus 로고
    • Factors associated with success of marketing authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency
    • Regnstrom, J. et al. Factors associated with success of marketing authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur. J. Clin. Pharmacol. 66, 39-48 (2010).
    • (2010) Eur. J. Clin. Pharmacol. , vol.66 , pp. 39-48
    • Regnstrom, J.1
  • 2
    • 78249234519 scopus 로고    scopus 로고
    • US FDA FDA [online]
    • US FDA. Adaptive design clinical trials for drugs and biologics. FDA [online], http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM201790. pdf (2010).
    • (2010) Adaptive Design Clinical Trials for Drugs and Biologics
  • 3
    • 70349652456 scopus 로고    scopus 로고
    • New approaches to drug safety: A pharmacovigilance toolkit
    • Wise, L. et al. New approaches to drug safety: a pharmacovigilance toolkit. Nature Rev. Drug Discov. 8, 779-782 (2009).
    • (2009) Nature Rev. Drug Discov. , vol.8 , pp. 779-782
    • Wise, L.1
  • 4
    • 53249132632 scopus 로고    scopus 로고
    • Balancing early market access to new drugs with the need for benefit/risk data: A mounting dilemma
    • Eichler, H. G. et al. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nature Rev. Drug Discov. 7, 818-826 (2008).
    • (2008) Nature Rev. Drug Discov. , vol.7 , pp. 818-826
    • Eichler, H.G.1
  • 5
    • 77950519526 scopus 로고    scopus 로고
    • Relative efficacy of drugs: An emerging issue between regulatory agencies and third-party payers
    • Eichler, H. G. et al. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nature Rev. Drug Discov. 9, 277-291 (2010).
    • (2010) Nature Rev. Drug Discov. , vol.9 , pp. 277-291
    • Eichler, H.G.1
  • 6
    • 79959416954 scopus 로고    scopus 로고
    • US FDA FDA [online]
    • US FDA. Advancing regulatory science for public health. FDA [online], http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ ucm228131.htm (2010).
    • (2010) Advancing Regulatory Science for Public Health


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.