메뉴 건너뛰기




Volumn 1323, Issue 1, 2014, Pages 11-21

The evolution of the regulatory framework for antibacterial agents

Author keywords

Antibacterial drug development; Antibacterial resistance; Regulatory framework

Indexed keywords

ANTIINFECTIVE AGENT;

EID: 84907958795     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1111/nyas.12441     Document Type: Article
Times cited : (30)

References (44)
  • 1
    • 84884597711 scopus 로고    scopus 로고
    • Anonymous, US Dept HHS, Centers for Disease Control and Prevention, Accessed April 13, 2014.
    • Anonymous. 2013. Antibiotic resistance threats in the United States, 2013. US Dept HHS, Centers for Disease Control and Prevention. http://www.cdc.gov/drugresistance/threat-report-2013/. Accessed April 13, 2014.
    • (2013) Antibiotic resistance threats in the United States, 2013
  • 2
    • 77951132271 scopus 로고    scopus 로고
    • The bacterial challenge: time to reach
    • European CDC/European Medicines Agency Joint Technical Report. Accessed April 13, 2014.
    • Anonymous. 2009. The bacterial challenge: time to reach. European CDC/European Medicines Agency Joint Technical Report. http://www.ecdc.europa.eu/en/publications/_layouts/forms/Publication_DispForm.aspx?ID=199&List=4f55ad51-4aed-4d32-b960-af70113dbb90. Accessed April 13, 2014.
    • (2009)
  • 3
    • 84878278251 scopus 로고    scopus 로고
    • 10 x '20 progress-development of new drugs active against Gram-negative bacilli: an update from the Infectious Diseases Society of America
    • Boucher, H.W., G.H. Talbot, D.K. Benjamin, Jr., et al. 2013. 10 x '20 progress-development of new drugs active against Gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin. Infect. Dis. 56: 1685-1694.
    • (2013) Clin. Infect. Dis. , vol.56 , pp. 1685-1694
    • Boucher, H.W.1    Talbot, G.H.2    Benjamin Jr, D.K.3
  • 4
    • 84885102013 scopus 로고    scopus 로고
    • Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009
    • Outterson, K., J.H. Powers, E. Seoane-Vazquez, et al. 2013. Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009. J. Law Med. Ethics 41: 688-696.
    • (2013) J. Law Med. Ethics , vol.41 , pp. 688-696
    • Outterson, K.1    Powers, J.H.2    Seoane-Vazquez, E.3
  • 5
    • 77953928054 scopus 로고    scopus 로고
    • Stoking the antibiotic pipeline
    • Morel, C.M. & E. Mossialos . 2010. Stoking the antibiotic pipeline. BMJ 340: 1115-1118.
    • (2010) BMJ , vol.340 , pp. 1115-1118
    • Morel, C.M.1    Mossialos, E.2
  • 6
    • 79953871631 scopus 로고    scopus 로고
    • Combating antimicrobial resistance: policy recommendations to save lives
    • Spellberg, B., M. Blaser, R.J. Guidos, et al. 2011. Combating antimicrobial resistance: policy recommendations to save lives. Clin. Infect. Dis. 52(Suppl 5): S397-428.
    • (2011) Clin. Infect. Dis. , vol.52 , pp. S397-S428
    • Spellberg, B.1    Blaser, M.2    Guidos, R.J.3
  • 7
    • 0242291985 scopus 로고    scopus 로고
    • Why is big Pharma getting out of antibacterial drug discovery?
    • Projan, S.J. 2003. Why is big Pharma getting out of antibacterial drug discovery? Curr. Opin. Microbiol. 6: 427-430.
    • (2003) Curr. Opin. Microbiol. , vol.6 , pp. 427-430
    • Projan, S.J.1
  • 8
    • 41649099025 scopus 로고    scopus 로고
    • Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study
    • Chastre, J., R. Wunderink, P. Prokocimer, et al. 2008. Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. Crit. Care Med. 36: 1089-1096.
    • (2008) Crit. Care Med. , vol.36 , pp. 1089-1096
    • Chastre, J.1    Wunderink, R.2    Prokocimer, P.3
  • 9
    • 0031930696 scopus 로고    scopus 로고
    • Treatment of ventilator-associated pneumonia with piperacillin-tazobactam/amikacin versus ceftazidime/amikacin: a multicenter, randomized controlled trial
    • Brun-Buisson, C., J.P. Sollet, H. Schweich, et al. 1998. Treatment of ventilator-associated pneumonia with piperacillin-tazobactam/amikacin versus ceftazidime/amikacin: a multicenter, randomized controlled trial. Clin. Infect. Dis. 26: 346-354.
    • (1998) Clin. Infect. Dis. , vol.26 , pp. 346-354
    • Brun-Buisson, C.1    Sollet, J.P.2    Schweich, H.3
  • 10
    • 44849104852 scopus 로고    scopus 로고
    • Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study
    • Lucasti, C., A. Jasovich, O. Umeh, et al. 2008. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study. Clin. Ther. 30: 868-883.
    • (2008) Clin. Ther. , vol.30 , pp. 868-883
    • Lucasti, C.1    Jasovich, A.2    Umeh, O.3
  • 11
    • 70349134718 scopus 로고    scopus 로고
    • Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis
    • Naber, K.G., L. Llorens, K. Kaniga, et al. 2009. Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis. Antimicrob. Agents Chemother. 53: 3782-3792.
    • (2009) Antimicrob. Agents Chemother. , vol.53 , pp. 3782-3792
    • Naber, K.G.1    Llorens, L.2    Kaniga, K.3
  • 12
    • 84856937734 scopus 로고    scopus 로고
    • Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study
    • Wunderink, R.G., M.S. Niederman, M.H. Kollef, et al. 2012. Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study. Clin. Infect. Dis. 54: 621-629.
    • (2012) Clin. Infect. Dis. , vol.54 , pp. 621-629
    • Wunderink, R.G.1    Niederman, M.S.2    Kollef, M.H.3
  • 13
    • 84864420306 scopus 로고    scopus 로고
    • A paradigm shift in drug development for treatment of rare multidrug-resistant gram-negative pathogens
    • Alemayehu, D., J. Quinn, J. Cook, et al. 2012. A paradigm shift in drug development for treatment of rare multidrug-resistant gram-negative pathogens. Clin. Infect. Dis. 55: 562-567.
    • (2012) Clin. Infect. Dis. , vol.55 , pp. 562-567
    • Alemayehu, D.1    Quinn, J.2    Cook, J.3
  • 14
    • 84874238564 scopus 로고    scopus 로고
    • A comprehensive regulatory framework to address the unmet need for new antibacterial treatments
    • Rex, J.H., B.I. Eisenstein, J. Alder, et al. 2013. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect. Dis. 13: 269-275.
    • (2013) Lancet Infect. Dis. , vol.13 , pp. 269-275
    • Rex, J.H.1    Eisenstein, B.I.2    Alder, J.3
  • 15
    • 77955706083 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic considerations in the design of hospital-acquired or ventilator-associated bacterial pneumonia studies: look before you leap
    • Ambrose, P.G., S.M. Bhavnani, E.J. Ellis-Grosse & G.L. Drusano, 2010. Pharmacokinetic-pharmacodynamic considerations in the design of hospital-acquired or ventilator-associated bacterial pneumonia studies: look before you leap! Clin. Infect. Dis. 51: S103-S110.
    • (2010) Clin. Infect. Dis. , vol.51 , pp. S103-S110
    • Ambrose, P.G.1    Bhavnani, S.M.2    Ellis-Grosse, E.J.3    Drusano, G.L.4
  • 16
    • 58149269479 scopus 로고    scopus 로고
    • Use of pharmacokinetics and pharmacodynamics in a failure analysis of community-acquired pneumonia: implications for future clinical trial study design
    • Ambrose, P.G. 2008. Use of pharmacokinetics and pharmacodynamics in a failure analysis of community-acquired pneumonia: implications for future clinical trial study design. Clin. Infect. Dis. 47: S225-S231.
    • (2008) Clin. Infect. Dis. , vol.47 , pp. S225-S231
    • Ambrose, P.G.1
  • 17
    • 34447126309 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of antimicrobials
    • Drusano, G.L. 2007. Pharmacokinetics and pharmacodynamics of antimicrobials. Clin. Infect. Dis. 45: S89-S95.
    • (2007) Clin. Infect. Dis. , vol.45 , pp. S89-S95
    • Drusano, G.L.1
  • 18
    • 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, J.Y., C.E. Garnett, J.V. Gobburu, et al. 2011. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin. Pharmacokinet. 50: 627-635.
    • (2011) Clin. Pharmacokinet. , vol.50 , pp. 627-635
    • Lee, J.Y.1    Garnett, C.E.2    Gobburu, J.V.3
  • 19
    • 0037534027 scopus 로고    scopus 로고
    • Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval
    • Peck, C.C., D.B. Rubin, & L.B. Sheiner, 2003. Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin. Pharmacol. Ther. 73: 481-490.
    • (2003) Clin. Pharmacol. Ther. , vol.73 , pp. 481-490
    • Peck, C.C.1    Rubin, D.B.2    Sheiner, L.B.3
  • 20
    • 79958811489 scopus 로고    scopus 로고
    • A randomized experiment comparing random and cutoff-based assignment
    • Shadish, W.R., R. Galindo, V.C. Wong, et al. 2011. A randomized experiment comparing random and cutoff-based assignment. Psychol. Methods 16: 179-191.
    • (2011) Psychol. Methods , vol.16 , pp. 179-191
    • Shadish, W.R.1    Galindo, R.2    Wong, V.C.3
  • 21
    • 84907955316 scopus 로고    scopus 로고
    • Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products
    • Gamalo, M.A., R.C. Tiwari & L.M. Lavange . 2014. Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products. Pharm Stat. 13: 25-40.
    • (2014) Pharm Stat , vol.13 , pp. 25-40
    • Gamalo, M.A.1    Tiwari, R.C.2    Lavange, L.M.3
  • 22
    • 84907953363 scopus 로고    scopus 로고
    • Use of historical control data for assessing treatment effects in clinical trials
    • Viele, K., S. Berry, B. Neuenschwander, et al. 2014. Use of historical control data for assessing treatment effects in clinical trials. Pharm Stat. 13: 41-54.
    • (2014) Pharm Stat , vol.13 , pp. 41-54
    • Viele, K.1    Berry, S.2    Neuenschwander, B.3
  • 23
    • 84884961808 scopus 로고    scopus 로고
    • Investigational antimicrobial agents of 2013
    • Pucci, M.J. & K. Bush . 2013. Investigational antimicrobial agents of 2013. Clin. Microbiol. Rev. 26: 792-821.
    • (2013) Clin. Microbiol. Rev. , vol.26 , pp. 792-821
    • Pucci, M.J.1    Bush, K.2
  • 24
    • 84894122170 scopus 로고    scopus 로고
    • Better tests, better care: improved diagnostics for infectious diseases
    • Caliendo, A.M., D.N. Gilbert, C.C. Ginocchio, et al. 2013. Better tests, better care: improved diagnostics for infectious diseases. Clin. Infect. Dis. 57(Suppl 3): S139-S170.
    • (2013) Clin. Infect. Dis. , vol.57 , pp. S139-S170
    • Caliendo, A.M.1    Gilbert, D.N.2    Ginocchio, C.C.3
  • 25
    • 84866666082 scopus 로고    scopus 로고
    • White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens
    • Infectious Diseases Society of America. 2012. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin. Infect. Dis. 55: 1031-1046.
    • (2012) Clin. Infect. Dis. , vol.55 , pp. 1031-1046
  • 26
    • 0345424863 scopus 로고    scopus 로고
    • Guidance for industry: antibacterial therapies for patients with unmet medical need for the treatment of serious bacterial diseases
    • Anonymous. US Dept HHS, FDA, CDER, CBER. Accessed April 13, 2014.
    • Anonymous. 2013. Guidance for industry: antibacterial therapies for patients with unmet medical need for the treatment of serious bacterial diseases. US Dept HHS, FDA, CDER, CBER. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Accessed April 13, 2014.
    • (2013)
  • 27
    • 84867332084 scopus 로고    scopus 로고
    • Overcoming the challenges to developing new antibiotics
    • Shlaes, D.M. & B. Spellberg . 2012. Overcoming the challenges to developing new antibiotics. Curr. Opin. Pharmacol. 12: 522-526.
    • (2012) Curr. Opin. Pharmacol. , vol.12 , pp. 522-526
    • Shlaes, D.M.1    Spellberg, B.2
  • 28
    • 84905379757 scopus 로고    scopus 로고
    • Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
    • European Medicines Agency, EMA/CHMP/351889/2013.
    • Committee for Medicinal Products for Human Use (CHMP). 2013. Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. European Medicines Agency, EMA/CHMP/351889/2013.
    • (2013)
  • 29
    • 84866648642 scopus 로고    scopus 로고
    • Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health
    • Talbot, G.H., J.H. Powers, T.R. Fleming, et al. 2012. Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin. Infect. Dis. 55: 1114-1121.
    • (2012) Clin. Infect. Dis. , vol.55 , pp. 1114-1121
    • Talbot, G.H.1    Powers, J.H.2    Fleming, T.R.3
  • 30
    • 84861503205 scopus 로고    scopus 로고
    • Editorial commentary: asking the right questions: morbidity, mortality, and measuring what's important in unbiased evaluations of antimicrobials
    • Powers, J.H. 2012. Editorial commentary: asking the right questions: morbidity, mortality, and measuring what's important in unbiased evaluations of antimicrobials. Clin. Infect. Dis. 54: 1710-1713.
    • (2012) Clin. Infect. Dis. , vol.54 , pp. 1710-1713
    • Powers, J.H.1
  • 31
    • 84857166213 scopus 로고    scopus 로고
    • Frequentist and Bayesian pharmacometric-based approaches to facilitate critically needed new antibiotic development: overcoming lies, damn lies, and statistics
    • Ambrose, P.G., J.P. Hammel, S.M. Bhavnani, et al. 2012. Frequentist and Bayesian pharmacometric-based approaches to facilitate critically needed new antibiotic development: overcoming lies, damn lies, and statistics. Antimicrob. Agents Chemother. 56: 1466-1470.
    • (2012) Antimicrob. Agents Chemother. , vol.56 , pp. 1466-1470
    • Ambrose, P.G.1    Hammel, J.P.2    Bhavnani, S.M.3
  • 32
    • 0033794265 scopus 로고    scopus 로고
    • Pharmacodynamics in the study of drug resistance and establishing in vitro susceptibility breakpoints: ready for prime time
    • Dudley, M.N. & P.G. Ambrose . 2000. Pharmacodynamics in the study of drug resistance and establishing in vitro susceptibility breakpoints: ready for prime time. Curr. Opin. Microbiol. 3: 515-521.
    • (2000) Curr. Opin. Microbiol. , vol.3 , pp. 515-521
    • Dudley, M.N.1    Ambrose, P.G.2
  • 33
    • 84907954376 scopus 로고    scopus 로고
    • Guidance for industry: microbiological data for systemic antibacterial drug products-development, analysis, and presentation
    • Anonymous. US Dept HHS, FDA, CDER and CBER, September.
    • Anonymous. 2009. Guidance for industry: microbiological data for systemic antibacterial drug products-development, analysis, and presentation. US Dept HHS, FDA, CDER and CBER, September. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064980.htm.
    • (2009)
  • 34
    • 84891598748 scopus 로고    scopus 로고
    • Commentary: revised susceptibility breakpoints: fear, loathing and good science
    • Dudley, M.N., P.G. Ambrose & R.N. Jones . 2013. Commentary: revised susceptibility breakpoints: fear, loathing and good science. Pediatr. Infect. Dis. J. 32: 970-971.
    • (2013) Pediatr. Infect. Dis. J. , vol.32 , pp. 970-971
    • Dudley, M.N.1    Ambrose, P.G.2    Jones, R.N.3
  • 35
    • 84863393482 scopus 로고    scopus 로고
    • The role of pharmacokinetics/pharmacodynamics in setting clinical MIC breakpoints: the EUCAST approach
    • Mouton, J.W., D.F. Brown, P. Apfalter, et al. 2012. The role of pharmacokinetics/pharmacodynamics in setting clinical MIC breakpoints: the EUCAST approach. Clin. Microbiol. Infect. 18: E37-45.
    • (2012) Clin. Microbiol. Infect. , vol.18 , pp. E37-E45
    • Mouton, J.W.1    Brown, D.F.2    Apfalter, P.3
  • 36
    • 79953760518 scopus 로고    scopus 로고
    • Cefazolin and enterobacteriaceae: rationale for revised susceptibility testing breakpoints
    • Turnidge, J.D. 2011. Cefazolin and enterobacteriaceae: rationale for revised susceptibility testing breakpoints. Clin. Infect. Dis. 52: 917-924.
    • (2011) Clin. Infect. Dis. , vol.52 , pp. 917-924
    • Turnidge, J.D.1
  • 37
    • 84876003793 scopus 로고    scopus 로고
    • Background and rationale for revised clinical and laboratory standards institute interpretive criteria (Breakpoints) for Enterobacteriaceae and Pseudomonas aeruginosa: I. Cephalosporins and Aztreonam
    • Dudley, M.N., P.G. Ambrose, S.M. Bhavnani, et al. 2013. Background and rationale for revised clinical and laboratory standards institute interpretive criteria (Breakpoints) for Enterobacteriaceae and Pseudomonas aeruginosa: I. Cephalosporins and Aztreonam. Clin. Infect. Dis. 56: 1301-1309.
    • (2013) Clin. Infect. Dis. , vol.56 , pp. 1301-1309
    • Dudley, M.N.1    Ambrose, P.G.2    Bhavnani, S.M.3
  • 38
    • 0031052377 scopus 로고    scopus 로고
    • Development of interpretive breakpoints for antifungal susceptibility testing: conceptual framework and analysis of in vitro-in vivo correlation data for fluconazole, itraconazole, and Candida infections
    • Rex, J.H., M.A. Pfaller, J.N. Galgiani, et al. 1997. Development of interpretive breakpoints for antifungal susceptibility testing: conceptual framework and analysis of in vitro-in vivo correlation data for fluconazole, itraconazole, and Candida infections. Clin. Infect. Dis. 24: 235-247.
    • (1997) Clin. Infect. Dis. , vol.24 , pp. 235-247
    • Rex, J.H.1    Pfaller, M.A.2    Galgiani, J.N.3
  • 39
    • 84907953480 scopus 로고    scopus 로고
    • 65 Fed. Reg. 81082, 81083
    • Anonymous. US Dept HHS, FDA.
    • Anonymous. 2000. 65 Fed. Reg. 81082, 81083. US Dept HHS, FDA.
    • (2000)
  • 40
    • 77956406697 scopus 로고    scopus 로고
    • Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices
    • Anonymous. US Dept HHS, FDA, CDER, CBER. Accessed April 13, 2014.
    • Anonymous. 2009. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. US Dept HHS, FDA, CDER, CBER. http://www.fda.gov/regulatoryinformation/guidances/ucm125126.htm. Accessed April 13, 2014.
    • (2009)
  • 41
    • 84890899357 scopus 로고    scopus 로고
    • Preserving antibiotics, rationally
    • Hollis, A. & Z. Ahmed . 2013. Preserving antibiotics, rationally. N. Engl. J. Med. 369: 2474-2476.
    • (2013) N. Engl. J. Med. , vol.369 , pp. 2474-2476
    • Hollis, A.1    Ahmed, Z.2
  • 42
    • 79961142293 scopus 로고    scopus 로고
    • Office of Health Economics, London. Accessed April 13, 2014.
    • Sharma, P. & A. Towse . 2010. New drugs to tackle antimicrobial resistance. Office of Health Economics, London. http://www.ohe.org/publications/article/new-drugs-to-tackle-antimicrobial-resistance-analysis-of-eu-policy-options-21.cfm. Accessed April 13, 2014.
    • (2010) New drugs to tackle antimicrobial resistance
    • Sharma, P.1    Towse, A.2
  • 43
    • 84856461571 scopus 로고    scopus 로고
    • The critical impact of time discounting on economic incentives to overcome the antibiotic market failure
    • Spellberg, B., P. Sharma & J.H. Rex . 2012. The critical impact of time discounting on economic incentives to overcome the antibiotic market failure. Nat. Rev. Drug Discov. 11: 168.
    • (2012) Nat. Rev. Drug Discov. , vol.11 , pp. 168
    • Spellberg, B.1    Sharma, P.2    Rex, J.H.3
  • 44
    • 84889575602 scopus 로고    scopus 로고
    • The value of single-pathogen antibacterial agents
    • Spellberg, B. & J.H. Rex . 2013. The value of single-pathogen antibacterial agents. Nat. Rev. Drug Discov. 12: 963.
    • (2013) Nat. Rev. Drug Discov. , vol.12 , pp. 963
    • Spellberg, B.1    Rex, J.H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.