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Volumn 24, Issue 12, 2006, Pages 1515-1519

Moving goalposts - Regulatory oversightof antibacterial drugs: The pharma company view

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT;

EID: 33845694440     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt1206-1515     Document Type: Note
Times cited : (4)

References (30)
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    • Smolinski, M.S., Hamburg, M.A. & Lederberg, J. (eds.). Institute of Medicine, Washington, DC
    • Smolinski, M.S., Hamburg, M.A. & Lederberg, J. (eds.). Microbial Threats to Health: Emergence, Detection, and Response (Institute of Medicine, Washington, DC, 2003).
    • (2003) Microbial Threats to Health: Emergence, Detection, and Response
  • 8
    • 10444287383 scopus 로고    scopus 로고
    • Task Force on Antimicrobial Availability. Alexandria, Virginia, July
    • Task Force on Antimicrobial Availability. Bad Bugs, No Drugs: As Antibiotic R&D Stagnates, a Public Health Crisis Brews (Infectious Diseases Society of America, Alexandria, Virginia, July 2004). 〈http://www. idsociety.org/pa/IDSA_Paper4_final_web.pdf〉
    • (2004) Bad Bugs, No Drugs: As Antibiotic R&D Stagnates, a Public Health Crisis Brews
  • 14
    • 33845697105 scopus 로고    scopus 로고
    • Japan Pharmaceutical and Medicine Safety Bureau, Evaluation and Licensing Division. PMSB/ELD, Tokyo, August
    • Japan Pharmaceutical and Medicine Safety Bureau, Evaluation and Licensing Division. Guidelines for the Clinical Evaluation of Antibacterial Drugs (PMSB/ELD, Tokyo, August 1998).
    • (1998) Guidelines for the Clinical Evaluation of Antibacterial Drugs
  • 17
    • 33845714532 scopus 로고    scopus 로고
    • Letter to Acting Commissioner of Food and Drugs Administration. September 28
    • Blaser, M.J. & Bartlett, J.G. Letter to Acting Commissioner of Food and Drugs Administration. (September 28, 2006). 〈http://www.idsociety.org/ Template.cfm?Section=Home&Template=/ContentManagement/ContentDisplay. cfm&ContentID=17039〉
    • (2006)
    • Blaser, M.J.1    Bartlett, J.G.2
  • 18
    • 33845702119 scopus 로고    scopus 로고
    • A swift predominance of ex-US sites
    • December 1
    • Getz, K.A. A swift predominance of ex-US sites. Applied Clinical Trials Magazine, December 1, 2005. 〈http://www.actmagazine.com/ appliedclinicaltrials/article/articleDetail.jsp?id=261633〉
    • (2005) Applied Clinical Trials Magazine
    • Getz, K.A.1
  • 24
    • 0242389364 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. FDA, Rockville, Maryland
    • US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry. E9 Statistical Principles for Clinical Trials (FDA, Rockville, Maryland, 1998). 〈http://www.fda.gov/cder/guidance/ICH_E9-fnl.pdf〉
    • (1998) Guidance for Industry. E9 Statistical Principles for Clinical Trials
  • 26
    • 0003556719 scopus 로고    scopus 로고
    • FDA, Rockville, Maryland, February
    • US Food and Drug Administration. Guidance for Industry. Population Pharmacokinetics (FDA, Rockville, Maryland, February 1999). 〈http://www. fda.gov/cder/guidance/1852fnl.pdf〉
    • (1999) Guidance for Industry. Population Pharmacokinetics


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.