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介绍美国食品与药品管理局的生物研究试验监查体系 被引量:4
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作者 杨建红 王亚敏 冯毅 《中国临床药理学杂志》 CAS CSCD 北大核心 2010年第9期711-714,共4页
在FDA的药品监管体系中,设置了生物研究试验监查体系,该体系以法规为依据,系统制定了相关监查技术指南,明确了监查的具体实施原则等。本文对其进行介绍,以期对我国的药品监管提供一些借鉴。
关键词 生物研究试验 监查体系
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美国FDA对药物临床试验的监管 被引量:10
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作者 陈永法 黄丽 《中国新药杂志》 CAS CSCD 北大核心 2012年第14期1578-1582,共5页
文中通过对FDA的生物研究试验监查体系(bioresearch monitoring program,BIMO)开展药物临床试验监查的法律法规依据、执行检查的相关机构、检查类型、检查流程和检查结果分类进行分析研究,得出FDA对药物临床试验的监管具备完善的法律法... 文中通过对FDA的生物研究试验监查体系(bioresearch monitoring program,BIMO)开展药物临床试验监查的法律法规依据、执行检查的相关机构、检查类型、检查流程和检查结果分类进行分析研究,得出FDA对药物临床试验的监管具备完善的法律法规依据、对药物临床试验的各参与方的检查全面深入、检查队伍专业、检查标准高,以期对我国药物临床试验的监管提供借鉴,从而全面提高我国药物临床试验的监管水平。 展开更多
关键词 伦理委员会 生物研究试验监查体系 临床试验
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Soil microbes alleviate allelopathy of invasive plants 被引量:12
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作者 Yang-Ping Li Yu-Long Feng +1 位作者 Ya-Jun Chen Yao-Hua Tian 《Science Bulletin》 SCIE EI CAS CSCD 2015年第12期1083-1091,I0002,共10页
Soil microbes are one of the most important determinants of allelopathic effects in the field. However, most studies testing the role of allelopathy in biological invasions did not consider the roles of soil microbes.... Soil microbes are one of the most important determinants of allelopathic effects in the field. However, most studies testing the role of allelopathy in biological invasions did not consider the roles of soil microbes. Here we tested the hypothesis that soil microbes which can degrade allelochemicals may accumulate in soils over time by adaptation and therefore increase the degradation of allelochemicals and alleviate the allelopathic effects in biological invasions. As expected, soil microbes signifi- cantly decreased the allelopathic effects of leaf leachates of eight in the nine invasive plant species studied. In addition, Ageratina adenophora showed lower allelopathic effects in soil with long or intermediately invasion history than those in soil with short invasion history. The two main allelo- chemicals of the invader were degraded more rapidly with increasing invasion history in the soil. Correspondingly,biomass and activity of the soil microbes were higher in the soils with long invasion history than in that with short invasion history. Our results indicate that soil microbes may graduaUy adapt to the allelochemicals of Ageratina and alleviate its allelopathic effects and thus support the above hypothesis. It is necessary to consider the effects of soil microbes when testing the roles of allelopathy or the novel weapons hypothesis in biological invasions. 展开更多
关键词 ADAPTATION ALLELOPATHY Degradationof allelochemicals Soil microbes Invasive plants
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