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全球新型抗感染药物加速审评审批机制研究
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作者 孙权 於莲莲 +1 位作者 张宇 张方 《沈阳药科大学学报》 CAS CSCD 北大核心 2023年第2期219-232,共14页
目的新型抗感染药物在实现患者生活质量改善方面较之于现有药物多表现为非劣效性,但对于抗击微生物耐药性(anti-microbial resistance,AMR)等社会角度,其价值显得更为重要。本文作者通过梳理国外医疗体系发达国家适用于新型抗感染药物... 目的新型抗感染药物在实现患者生活质量改善方面较之于现有药物多表现为非劣效性,但对于抗击微生物耐药性(anti-microbial resistance,AMR)等社会角度,其价值显得更为重要。本文作者通过梳理国外医疗体系发达国家适用于新型抗感染药物的快速审查程序,对我国新型抗感染药物快速审查程序与各国进行对比及优劣势探析,发现我国现有模式的不足,结合国外经验为我国加快新型抗感染药物审评审批提供政策参考。方法对比国内外适用于新型抗感染药物的快速审评审批的相关政策,为国内新新型抗感染药物快速审查制度提出优化建议。结果美国、英国、日本、韩国、加拿大和欧盟地区的新药加速审查制度实施较早、覆盖全面且有多种加速审查模式助力新型抗感染药物获批。欧美地区还设有多个AMR相关的非政府组织与药品审查部门合作,助力新型抗感染药物获批。相比而言,我国现有新型抗感染药物快速审查通道适用条件存在重叠,缺乏弹性,审查总时长远超拟定周期,新药快速审查制度对新型抗感染药物的适用度不高。结论我国现有新药快速审查机制无法有效助力新型抗感染药物获批,国外新型抗感染药物审评审批程序的先进经验对于我国相关部委优化新药快速审查机制具有参考价值,特别是对新型抗感染药物专设的绿色审查通道以及非社会组织的积极参与是激励新药研发单位关注抗感染药物研发的重大举措。我国应基于国情,结合国外政策体系的思路,打造更加适用于新型抗感染药物的快速审查通道,同时调动各界力量,共同加速新型抗感染药物市场准入进程。 展开更多
关键词 新型抗感染药物 审评审批 加速审查 市场准入
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Two bacterial infection models in tree shrew for evaluating the efficacy of antimicrobial agents 被引量:15
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作者 李盛安 李文辉 张云 《Zoological Research》 CAS CSCD 北大核心 2012年第1期1-6,共6页
Animal models are essential for the development of new anti-infectious drugs.Although some bacterial infection models have been established in rodents,small primate models are rare.Here,we report on two bacterial infe... Animal models are essential for the development of new anti-infectious drugs.Although some bacterial infection models have been established in rodents,small primate models are rare.Here,we report on two bacterial infection models established in tree shrew(Tupaia belangeri chinensis).A burnt skin infection model was induced by dropping 5×106 CFU of Staphylococcus aureus on the surface of a wound after a third degree burn.This dose of S.aureus caused persistent infection for 7 days and obvious inflammatory response was observed 4 days after inoculation.A Dacron graft infection model,2×106 CFU of Pseudomonas aeruginosa also caused persistent infection for 6 days,with large amounts of pus observed 3 days after inoculation.These models were used to evaluate the efficacy of levofloxacin(LEV) and cefoperazone(CPZ),which reduced the viable bacteria in skin to 4log10 and 5log10 CFU/100 mg tissue,respectively.The number of bacteria in graft was significantly reduced by 4log10 CFU/mL treatment compared to the untreated group(P0.05).These results suggest that two bacterial infection models were successfully established in tree shrew using P.aeruginosa and S.aureus.In addition,tree shrew was susceptible to P.aeruginosa and S.aureus,thus making it an ideal bacterial infection animal model for the evaluation of new antimicrobials. 展开更多
关键词 Tree shrew Novel antimicrobials Graft infection Staphylococcus aureus Pseudomonas aeruginosa
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