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Volumn 100, Issue 6, 2016, Pages 597-599

Regulatory Pathways for New Antimicrobial Agents: Trade-offs to Keep the Perfect From Being the Enemy of the Good

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; NEW DRUG;

EID: 84991490744     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.510     Document Type: Note
Times cited : (3)

References (10)
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  • 2
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    • Antibacterial drug development: challenges, recent developments, and future considerations
    • Nambiar, S., Laessig, K., Toerner, J., Farley, J. & Cox, E. Antibacterial drug development: challenges, recent developments, and future considerations. Clin. Pharmacol. Ther. 96, 147–149 (2014).
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    • Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI)
    • Wagenlehner, F.M., Umeh, O., Steenbergen, J., Yuan, G. & Darouiche, R.O. Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI). Lancet 385, 1949–1956 (2015).
    • (2015) Lancet , vol.385 , pp. 1949-1956
    • Wagenlehner, F.M.1    Umeh, O.2    Steenbergen, J.3    Yuan, G.4    Darouiche, R.O.5
  • 4
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    • Ceftolozane/tazobactam plus metronidazole for complicated intra-abdominal infections in an era of multidrug resistance: results from a randomized, double-blind, phase 3 trial (ASPECT-cIAI)
    • Solomkin, J. et al. Ceftolozane/tazobactam plus metronidazole for complicated intra-abdominal infections in an era of multidrug resistance: results from a randomized, double-blind, phase 3 trial (ASPECT-cIAI). Clin. Infect. Dis. 60, 1462–1471 (2015).
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    • Solomkin, J.1
  • 5
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    • Efficacy and safety of ceftazidime-avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infection: results from a randomized, controlled, double-blind, phase 3 program
    • Mazuski, J.E. et al. Efficacy and safety of ceftazidime-avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infection: results from a randomized, controlled, double-blind, phase 3 program. Clin. Infect. Dis. 62, 1380–1389 (2016).
    • (2016) Clin. Infect. Dis. , vol.62 , pp. 1380-1389
    • Mazuski, J.E.1
  • 6
    • 84995390345 scopus 로고    scopus 로고
    • Ceftazidime-avibactam versus doripenem for the treatment of complicated urinary tract infections, including acute pyelonephritis: RECAPTURE, a phase 3 randomized trial program
    • Wagenlehner, F.M. et al. Ceftazidime-avibactam versus doripenem for the treatment of complicated urinary tract infections, including acute pyelonephritis: RECAPTURE, a phase 3 randomized trial program. Clin. Infect. Dis. 63, 754–762 (2016).
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    • Wagenlehner, F.M.1
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    • Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis
    • Marty, F.M. et al. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect. Dis. 16, 828–837 (2016).
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  • 9
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