메뉴 건너뛰기




Volumn 63, Issue , 2016, Pages S57-S59

Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

Author keywords

Antibiotic development; antimicrobial resistance; trial networks

Indexed keywords

ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT;

EID: 85010866375     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciw244     Document Type: Article
Times cited : (29)

References (17)
  • 3
    • 84959919724 scopus 로고    scopus 로고
    • The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance
    • Kostyanev T, Bonten MJ, O'Brien S, et al. The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance. J Antimicrob Chemother 2016; 71:290-5.
    • (2016) J Antimicrob Chemother , vol.71 , pp. 290-295
    • Kostyanev, T.1    Bonten, M.J.2    O'Brien, S.3
  • 4
    • 84874238564 scopus 로고    scopus 로고
    • A comprehensive regulatory framework to address the unmet need for new antibacterial treatments
    • Rex JH, Eisenstein BI, Alder J, et al. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis 2013; 13:269-75.
    • (2013) Lancet Infect Dis , vol.13 , pp. 269-275
    • Rex, J.H.1    Eisenstein, B.I.2    Alder, J.3
  • 6
    • 84904611888 scopus 로고    scopus 로고
    • European Medicines Agency, Committee for Medicinal Products for Human Use EMA/CHMP/351889/2013. Available at Accessed 1 May 2015
    • European Medicines Agency, Committee for Medicinal Products for Human Use. Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. EMA/CHMP/351889/2013. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2013/11/WC500153953.pdf. Accessed 1 May 2015.
    • Addendum to the Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections
  • 7
    • 84962510658 scopus 로고    scopus 로고
    • Antibiotic reimbursement in a sales-delinked model: Context and a benchmark-based global approach
    • Rex JH, Outterson K. Antibiotic reimbursement in a sales-delinked model: context and a benchmark-based global approach. Lancet Infect Dis 2016; 16:500-5.
    • (2016) Lancet Infect Dis , vol.16 , pp. 500-505
    • Rex, J.H.1    Outterson, K.2
  • 8
    • 84873803857 scopus 로고    scopus 로고
    • International rare cancers initiative
    • Keat N, Law K, Seymour M, et al. International rare cancers initiative. Lancet Oncol 2013; 14:109-10.
    • (2013) Lancet Oncol , vol.14 , pp. 109-110
    • Keat, N.1    Law, K.2    Seymour, M.3
  • 9
    • 84887907695 scopus 로고    scopus 로고
    • Managing transmission of carbapenem-resistant Enterobacteriaceae in healthcare settings: A view from the trenches
    • Palmore TN, Henderson DK. Managing transmission of carbapenem-resistant Enterobacteriaceae in healthcare settings: a view from the trenches. Clin Infect Dis 2013; 57:1593-9.
    • (2013) Clin Infect Dis , vol.57 , pp. 1593-1599
    • Palmore, T.N.1    Henderson, D.K.2
  • 10
    • 33845696211 scopus 로고    scopus 로고
    • Pharmacokinetics-pharmacodynamics of antimicrobial therapy: It's not just for mice anymore
    • Ambrose PG, Bhavnani SM, Rubino CM, et al. Pharmacokinetics-pharmacodynamics of antimicrobial therapy: it's not just for mice anymore. Clin Infect Dis 2007; 44:79-86.
    • (2007) Clin Infect Dis , vol.44 , pp. 79-86
    • Ambrose, P.G.1    Bhavnani, S.M.2    Rubino, C.M.3
  • 11
    • 84960172708 scopus 로고    scopus 로고
    • Developing outcomes assessments as endpoints for registrational clinical trials of antibacterial drugs: 2015 update from the Biomarkers Consortium of the Foundation for the National Institutes of Health
    • Talbot GH, Powers JH, Hoffmann SC. Developing outcomes assessments as endpoints for registrational clinical trials of antibacterial drugs: 2015 update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin Infect Dis 2016; 62:603-7.
    • (2016) Clin Infect Dis , vol.62 , pp. 603-607
    • Talbot, G.H.1    Powers, J.H.2    Hoffmann, S.C.3
  • 15
    • 84878279266 scopus 로고    scopus 로고
    • Food and Drug Administration Center for Drug Evaluation Available at Accessed 29 April 2016
    • Food and Drug Administration, Center for Drug Evaluation. Guidance for industry: complicated intra-abdominal infections: developing drugs for treatment. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Accessed 29 April 2016.
    • Guidance for Industry: Complicated Intra-abdominal Infections: Developing Drugs for Treatment
  • 16
    • 84878311196 scopus 로고    scopus 로고
    • Food and Drug Administration Center for Drug Evaluation Available at Accessed 29 April 2016
    • Food and Drug Administration, Center for Drug Evaluation. Guidance for industry: complicated urinary tract infections: developing drugs for treatment. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Accessed 29 April 2016.
    • Guidance for Industry: Complicated Urinary Tract Infections: Developing Drugs for Treatment
  • 17
    • 84925276177 scopus 로고    scopus 로고
    • A simulation study evaluating bio-creep risk in serial non-inferiority clinical trials for preservation of effect
    • Odem-Davis K, Fleming TR. A simulation study evaluating bio-creep risk in serial non-inferiority clinical trials for preservation of effect. Stat Biopharm Res 2015; 7:12-24.
    • (2015) Stat Biopharm Res , vol.7 , pp. 12-24
    • Odem-Davis, K.1    Fleming, T.R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.