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Volumn 57, Issue 3, 2013, Pages 903-907

Boceprevir dosing for late responders and null responders: The role of bridging data between treatment-naïve and -experienced subjects

Author keywords

[No Author keywords available]

Indexed keywords

BOCEPREVIR; PEGINTERFERON ALPHA; RIBAVIRIN; VIRUS RNA;

EID: 84874456956     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.25843     Document Type: Article
Times cited : (13)

References (11)
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  • 4
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    • Interferon responsiveness does not change in experienced hepatitis C subjects: implications for drug development and clinical decisions
    • submitted
    • Liu J, Florian J, Birnkrant D, Murray J, Jadhav PR. Interferon responsiveness does not change in experienced hepatitis C subjects: implications for drug development and clinical decisions. HEPATOLOGY [submitted].
    • HEPATOLOGY
    • Liu, J.1    Florian, J.2    Birnkrant, D.3    Murray, J.4    Jadhav, P.R.5
  • 5
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    • Topiramate label. In: Food and Drug Administration, Center for Drug Evaluation and Research: (http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028, 285s009s013s015s018s019s020s022lbl.pdf).
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    • Topiramate label. In: Food and Drug Administration, Center for Drug Evaluation and Research:
    • Topiramate label. In: Food and Drug Administration, Center for Drug Evaluation and Research: (http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042, 844s036lbl.pdf).
  • 7
    • 73849139599 scopus 로고    scopus 로고
    • Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalation anthrax in children
    • Li F, Nandy P, Chien S, Noel GJ, Tornoe CW. Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalation anthrax in children. Antimicrob Agents Chemother 2010; 54: 375-379.
    • (2010) Antimicrob Agents Chemother , vol.54 , pp. 375-379
    • Li, F.1    Nandy, P.2    Chien, S.3    Noel, G.J.4    Tornoe, C.W.5
  • 8
    • 80052495952 scopus 로고    scopus 로고
    • Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008
    • Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet 2011; 50: 627-35.
    • (2011) Clin Pharmacokinet , vol.50 , pp. 627-635
    • Lee, J.Y.1    Garnett, C.E.2    Gobburu, J.V.3    Bhattaram, V.A.4    Brar, S.5    Earp, J.C.6
  • 9
    • 84874451873 scopus 로고    scopus 로고
    • Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. In: Food and Drug Administration, Center for Drug Evaluation and Research:
    • Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. In: Food and Drug Administration, Center for Drug Evaluation and Research: (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryinformation/Guidances/ucm078749.pdf).
  • 10
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    • Antiviral Drugs Advisory Committee: FDA Briefing Information for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee. In: US Food and Drug Administration, Center for Drug Evaluation and Research: Accessed September 2
    • Antiviral Drugs Advisory Committee: FDA Briefing Information for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee. In: US Food and Drug Administration, Center for Drug Evaluation and Research: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252341.pdf. Accessed September 2, 2011.
    • (2011)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.