The FDA reboot of antibiotic development.
作者信息
Shlaes David M, Sahm Dan, Opiela Carol, Spellberg Brad
机构信息
Anti-infectives Consulting, LLC, Stonington, Connecticut, USA.
出版信息
Antimicrob Agents Chemother. 2013 Oct;57(10):4605-7. doi: 10.1128/AAC.01277-13. Epub 2013 Jul 29.
Abstract
摘要
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Vital signs: carbapenem-resistant Enterobacteriaceae.生命体征：耐碳青霉烯肠杆菌科。
MMWR Morb Mortal Wkly Rep. 2013 Mar 8;62(9):165-70.
2
The future of antibiotics and resistance.抗生素与耐药性的未来。
N Engl J Med. 2013 Jan 24;368(4):299-302. doi: 10.1056/NEJMp1215093.
3
A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.制定全面的监管框架，以满足新抗菌治疗方法的未满足需求。
Lancet Infect Dis. 2013 Mar;13(3):269-75. doi: 10.1016/S1473-3099(12)70293-1. Epub 2013 Jan 15.
4
A long and winding road; evolution of antimicrobial drug development - crisis management.漫漫长路；抗菌药物研发的演变——危机管理。
Expert Rev Anti Infect Ther. 2012 Nov;10(11):1311-9. doi: 10.1586/eri.12.131.
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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.白皮书：关于治疗耐药细菌病原体引起的感染的抗菌药物优越性和生物体特异性临床试验实施的建议。
Clin Infect Dis. 2012 Oct;55(8):1031-46. doi: 10.1093/cid/cis688. Epub 2012 Aug 13.
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The critical impact of time discounting on economic incentives to overcome the antibiotic market failure.时间贴现对克服抗生素市场失灵的经济激励的关键影响。
Nat Rev Drug Discov. 2012 Feb 1;11(2):168. doi: 10.1038/nrd3560-c1.
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Acute bacterial skin and skin structure infection trials: the bad is the enemy of the good.急性细菌性皮肤及皮肤结构感染试验：差的是好的敌人。
Clin Infect Dis. 2011 Dec;53(12):1308-9; author reply 1309-10. doi: 10.1093/cid/cir741. Epub 2011 Oct 25.
8
Fix the antibiotics pipeline.修复抗生素研发流程。
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9
Sulphanilamide in the Treatment of Erysipelas.磺胺治疗丹毒
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10
Prontosil in Erysipelas.百浪多息治疗丹毒。
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