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Volumn 51, Issue SUPPL. 1, 2010, Pages

Considerations in undertaking a clinical development program for Hospital-acquired bacterial pneumonia and/or ventilator-associated bacterial pneumonia

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT;

EID: 77955696914     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/653064     Document Type: Conference Paper
Times cited : (9)

References (14)
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    • Ambrose PG, Bhavnani SM, Ellis-Grosse EJ, Drusano GL. Pharma-cokinetic-pharmacodynamic considerations in the design of hospital-acquired or ventilator-associated pneumonia studies: look before you leap! Clin Infect Dis 2010; 51(Suppl 1):S103-S110 (in this supplement).
    • (2010) Clin Infect Dis , vol.51 , Issue.SUPPL. 1
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  • 5
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    • Efficacy as an important facet of "safety" in clinical trials: How can we do our best for our patients?
    • Talbot GH. Efficacy as an important facet of "safety" in clinical trials: how can we do our best for our patients? Clin Infect Dis 2008; 47: S180-S185.
    • (2008) Clin Infect Dis , vol.47
    • Talbot, G.H.1
  • 6
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    • Center for Drug Evaluation and Research. Food and Drug Administration March Accessed 27 April 2009
    • Center for Drug Evaluation and Research. Food and Drug Administration. Guidance for industry: community-acquired bacterial pneumonia: developing drugs for treatment. March 2009. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm123686.pdf. Accessed 27 April 2009.
    • (2009) Guidance for Industry: Community-acquired Bacterial Pneumonia: Developing Drugs for Treatment
  • 7
    • 77955674884 scopus 로고    scopus 로고
    • In-vivo pharmacodynamic activity of PPI-0903, a new cephalosporin prodrugs against multiple bacteria in murine thigh and lung infection models
    • (Washington, DC). 30 October-2 November
    • Andes DR, Craig WA. In-vivo pharmacodynamic activity of PPI-0903, a new cephalosporin prodrugs against multiple bacteria in murine thigh and lung infection models. In: Program and abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (Washington, DC). 30 October-2 November 2004. Paper A-1870.
    • (2004) Program and Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy
    • Andes, D.R.1    Craig, W.A.2
  • 8
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    • Inhibition of daptomycin by pulmonary surfactant in vitro modeling and clinical impact
    • Silverman JA, Mortia LI, VanPrangh ADG, Li T, Alder J. Inhibition of daptomycin by pulmonary surfactant In vitro modeling and clinical impact. J Infect Dis 2005; 191:2149-2152.
    • (2005) J Infect Dis , vol.191 , pp. 2149-2152
    • Silverman, J.A.1    Mortia, L.I.2    Adg, V.3    Li, T.4    Alder, J.5
  • 9
    • 37849002056 scopus 로고    scopus 로고
    • Intrapulmonary distribution of intravenous telavancin in healthy subjects and effect of pulmonary surfactant on in vitro activities of telavancin and other antibiotics
    • Gotfried MH, Shaw J-P, Benton BM, et al. Intrapulmonary distribution of intravenous telavancin in healthy subjects and effect of pulmonary surfactant on in vitro activities of telavancin and other antibiotics. Antimicrob Agents Chemother 2008; 52(1):92-97.
    • (2008) Antimicrob Agents Chemother , vol.52 , Issue.1 , pp. 92-97
    • Gotfried, M.H.1    Shaw, J.-P.2    Benton, B.M.3
  • 10
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    • Use of population pharmacokinetic modeling and Monte Carlo simulation to describe the pharmacodynamic profile of cefditoren in plasma and epithelial lining fluid
    • Lodise TP, Kinzig-Schippers M, Drusano GL, et al. Use of population pharmacokinetic modeling and Monte Carlo simulation to describe the pharmacodynamic profile of cefditoren in plasma and epithelial lining fluid. Antimicrob Agents Chemother 2008; 52:1945-1951.
    • (2008) Antimicrob Agents Chemother , vol.52 , pp. 1945-1951
    • Lodise, T.P.1    Kinzig-Schippers, M.2    Drusano, G.L.3
  • 11
    • 67650000576 scopus 로고    scopus 로고
    • Comparison of the pharmacodynamics of biapenem in bronchial epithelial lining fluid in healthy volunteers given half-hour and three-hour intravenous infusions
    • Kikuchi E, Kikuchi J, Nasuhara Y, Oizumi S, Ishizaka A, Nishimura M. Comparison of the pharmacodynamics of biapenem in bronchial epithelial lining fluid in healthy volunteers given half-hour and three-hour intravenous infusions. Antimicrob Agents Chemother 2009; 53: 2799-2803.
    • (2009) Antimicrob Agents Chemother , vol.53 , pp. 2799-2803
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    • Center for Drug Evaluation and Research, US Food and Drug Administration. Nosocomial pneumonia: developing antimicrobial drugs for treatment. July 1998. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm071170.pdf. Accessed 27 April 2009.
    • (1998) Nosocomial Pneumonia: Developing Antimicrobial Drugs for Treatment
  • 14
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