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Climate Change vs Cultural Heritage: An Adaptation Strategy for the Archaeological Site of Ancient Messene
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作者 Vasiliki Pougkakioti Miltiades Lazoglou Eleni Maistrou 《American Journal of Climate Change》 2023年第3期456-488,共33页
This article examines the effects of climate change on archaeological sites, using as a case study the archaeological site of Ancient Messene in Greece, and proposes an integrated adaptation strategy. In order to dete... This article examines the effects of climate change on archaeological sites, using as a case study the archaeological site of Ancient Messene in Greece, and proposes an integrated adaptation strategy. In order to determine the site’s most significant risks, a climate data analysis was conducted, taking into account three different climate emission scenarios (Representative Concentration Pathways) and two future periods (2031-2060, 2071-2100). The Intergovernmental Panel on Climate Change (IPCC) vulnerability assessment methodology was adopted to assess the vulnerability of the archaeological site to the effects of climate change. This is the first time such a methodology has been followed in Greece. The analysis revealed that the site’s critical hazards are fire, desertification, and flooding. The geographical location of the site in an intensely dry microclimate and the lack of safe and functional electromechanical and road infrastructure increase its vulnerability. The materials of the monuments are indirectly and directly impacted by climate change, whereas the vegetation is negatively impacted by the frequency of extreme events, especially wildfires. Based on the analysis results, a five-axis adaptation strategy was developed. 展开更多
关键词 Climate change Cultural Heritage Archaeological site VULNERABILITY RESILIENCE Adaptive Capacity Adaptation Strategy
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Estimation of Site Effects on Stations in the Capital Circle Region Using the Generalized Inversion Method
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作者 Shi Haixia Xiu Jigang +2 位作者 Chen Zhangli Wang Qincai Hua Wei 《Earthquake Research in China》 2010年第2期198-210,共13页
Generalized Inversion Method has been used to estimate the spatial variation of site effects,using the digital data of SH-waves recorded by 63 stations in the Capital Circle Region of China from 2001 to 2006.We gained... Generalized Inversion Method has been used to estimate the spatial variation of site effects,using the digital data of SH-waves recorded by 63 stations in the Capital Circle Region of China from 2001 to 2006.We gained the site effects of all stations participating in the calculation.We found that the site effect of rock was stabile and about 1.0 from 1.0Hz to 10.0Hz,while the site effect of deposit was high in low frequencies,about 3 ~ 7 from 1.0Hz to 8.0Hz,and the site effect was protuberant at about 5.0Hz,then fell as the frequency increased.The result shows the shape and intensity of station site effects are mainly influenced by the lithology below the station,and possibly also by the local geological structure. 展开更多
关键词 首都圈地区 反演方法 广义 台站 频率范围 估计 场地效应 空间变化
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Impact of Holocene environmental change on temporal-spatial distribution of Neolithic sites in Huaihe River Basin, Anhui Province 被引量:5
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作者 HUANG Run ZHU Cheng +1 位作者 GUAN Yong ZHENG Chaogui 《Journal of Geographical Sciences》 SCIE CSCD 2006年第2期199-208,共10页
The Huaihe River basin of Anhui is not only a transitional zone of physical geography, but also a convergent area of many cultures in China. It is one of the sensitive ecotones to global changes and the birthplace of ... The Huaihe River basin of Anhui is not only a transitional zone of physical geography, but also a convergent area of many cultures in China. It is one of the sensitive ecotones to global changes and the birthplace of Chinese civilization. Using the field archaeological data and the sporo-pollens and the age data of the drilling cores, we analysed Neolithic cultural development and environmental evolution in the Huaihe River basin of Anhui. According to the combination of some research results in archaeology with environmental evolution research, this paper discusses the relationship between culture and environment in the Huaihe River basin of Anhui. The Neolithic cultural development was strongly impacted by the environmental change. The primitive culture (Shishanzi) was developed in the beginning of the Holocene Megathermal Period with distinct regional feature of the culture. From 6.5 kaBP to 5.5 kaBP, the climate changed warmer and wetter. The frequent occurrence of flood and waterlog due to such a climate regime and high sea level caused the earth's surface environment deteriorated in the Huaihe River basin of Anhui and the interruption of the Neolithic cultural development, hence a lack of archaeological sites. From 5.5 kaBP to 4.0 kaBP, the climate changed from wet to dry, the natural environment was propitious to human survival. Dawenkou Culture and Longshan Culture flourished in this period. The Neolithic cultural development, the number of the sites and their distribution characteristics of the sites in the study area differed apparently from those in Central China and Shandong Province. 展开更多
关键词 HOLOCENE environmental change Neolithic site temporal-spatial distribution Huaihe Riverbasin of Anhui
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Joint processing and analysis of seismic gravity measurements in Capital Circle area
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作者 贾民育 马丽 +3 位作者 刘少明 张晶 孙少安 王武星 《Acta Seismologica Sinica(English Edition)》 EI CSCD 2006年第4期438-447,共10页
In Capital Circle area, there are three groups of repeated gravity measurements observed by different institutes using different instruments or methods. The simultaneous adjustment of absolute and relative measurement... In Capital Circle area, there are three groups of repeated gravity measurements observed by different institutes using different instruments or methods. The simultaneous adjustment of absolute and relative measurements and the elimination of systematic error among the relative measurements have been carded out in this paper. Thus an unified temporal gravity change system with absolute reference has been established. On the basis of this, the crustal subsidence effect on gravity, which belongs to non-tectonic factor, is analyzed and the station displacement corrections are carried out, so that the long-wave disturbance is eliminated. So far our following aims are realized: the advantages of the absolute and relative measurement methods are complementary to each other; the contradiction and environment disturbance are eliminated; the amounts of information are enlarged; the sampling interval of time domain is compressed. In a word, the ability of identifying the tectonic activity process is enhanced. The results show that: there are systematic errors between the two groups of relative measurements and within the data of 10 campaigns ; the uneven local crustal subsidence in the southeast of the study area results in a linear rise of gravity value at 10 stations; they can be corrected by the regression analysis. The maps of revised temporal gravity change can obviously and integrally reflect the Ms=5.0 earthquake in Guye on October 6, 1995. 展开更多
关键词 capital Circle area temporal gravity change relative measurement absolute measurement unified system
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A Study on Foreign Capital M&A of Agribusiness
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作者 Juan XU 《Asian Agricultural Research》 2016年第7期21-23,26,共4页
After joining the WTO,Chinese government has gradually fulfilled various promises,such as cancellation of restrictions on foreign capital share ratio,and opening up of foreign investment areas. There are new changes i... After joining the WTO,Chinese government has gradually fulfilled various promises,such as cancellation of restrictions on foreign capital share ratio,and opening up of foreign investment areas. There are new changes in foreign merchants' direct investment in China,and it shifts from " green investment" featured by high risk and long period of return on investment to cross-border M&A. Since Coca-Cola failed to complete M&A of Huiyuan Juice in 2009,people have paid close attention to foreign capital M&A of domestic agribusiness. New changes and features appear in both scale and industrial areas,and M&A incidents have mushroomed in the industries of meat processing,wine,dairy and beverage,and the related industries have become the hot areas of cross-border M&A. Through the study of M&A incidents in China's agriculture-related areas in recent years,this paper aims to offer an overview of current foreign capital M&A of China's agribusiness in terms of scale and industry. 展开更多
关键词 FOREIGN capital M&A Agribusiness SCALE changE INDUSTRIAL changE
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Application of 3S Technology in Dynamic Monitoring of Capital Farmland
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作者 Xiaoyan WANG Guoye REN 《Asian Agricultural Research》 2013年第6期125-128,132,共5页
Firstly,this paper introduces current situations of protection of capital farmland. According to current situations,it analyzes significance in protecting capital farmland and significance and functions of application... Firstly,this paper introduces current situations of protection of capital farmland. According to current situations,it analyzes significance in protecting capital farmland and significance and functions of application of 3S technology in dynamic monitoring of capital farmland. With the aid of examples,it discusses functions of remote sensing and GIS in dynamic monitoring of capital farmland. It is believed that 3S technology not only can provide accurate parcel data of capital farmland changes for reviewing land change survey,but also can provide data for monitoring development situations of capital farmland,as well as provide basic current information for decision-making department. 展开更多
关键词 capital FARMLAND changING INFORMATION 3S technolog
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The Principle of Authenticity and the Protection and Renewal of the Qujiang Site in Ancient Chang'an
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作者 ZHANG Xinguo ZHANG Gang +2 位作者 CHENG Yingjie YANG Meihua YANG Xue 《Journal of Landscape Research》 2018年第6期63-65,70,共4页
In order to explore the protection and renewal law of historic sites in the process of contemporary urban construction, combined with the protection and renewal practice of Qujiang garden cultural landscape heritage s... In order to explore the protection and renewal law of historic sites in the process of contemporary urban construction, combined with the protection and renewal practice of Qujiang garden cultural landscape heritage sites in ancient Chang'an, this paper analyzed the authenticity in the protection and renewal of different historic sites, and explored the possibility of flexible use of the concept of authenticity in the process of protection and renewal of historic sites. 展开更多
关键词 AUTHENTICITY Ancient chang’an Qujiang site PROTECTION RENEWAL
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Green Energy: Examining Their Effects on Heritage Sites and Climate Change Mitigation
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作者 Mehdi S. Kaddory Al-Zubaidy 《Open Journal of Civil Engineering》 2015年第1期39-52,共14页
The damage which is brought about by global warming and climate change to heritage sites is more or less immutable. However, further deterioration could be slowed, if not stopped, with the patronization of green energ... The damage which is brought about by global warming and climate change to heritage sites is more or less immutable. However, further deterioration could be slowed, if not stopped, with the patronization of green energy. Three sources of green energy, namely solar power, wind power, and hydropower were discussed in this research. Their indirect roles in preserving heritage sites were examined and their cumulative effects on mitigating climate change were also cited. Results showed that the climate might have been continually changing for the past thousands of years. The effects of climate change and global warming on the arctic ice, carbon dioxide concentration, sea levels, global surface temperature and land ice status were undeniable. These factors greatly contributed to the deterioration of the preservation of world heritage sites. 展开更多
关键词 Green ENERGY CLIMATE changE RENEWABLE ENERGY Sources World HERITAGE site (WHS) CLIMATE changE Mitigation Global WARMING
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Climate Change Adaptation and Historic Settlements: Evidence from the Old Town of Corfu
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作者 Eleni Maistrou Vasiliki Pougkakioti Miltiadis Lazoglou 《American Journal of Climate Change》 2023年第3期418-455,共38页
The Old Town of Corfu is an excellent example of a historic town and a World Heritage Site, distinguished by its authentic and unique character, as reflected in its Venetian-era fortifications and extensive historic b... The Old Town of Corfu is an excellent example of a historic town and a World Heritage Site, distinguished by its authentic and unique character, as reflected in its Venetian-era fortifications and extensive historic building stock. Simultaneously, the Old Town of Corfu is also a vibrant modern city vulnerable to various pressures, including climate change. This paper aims to evaluate the effects of climate change on this modern city monument, assess its vulnerability using the Intergovernmental Panel on Climate Change’s methodology, and develop a comprehensive set of adaptation proposals. The methodology of this paper is based on the analysis of climate data for the Old Town of Corfu, from which the assessment of the extreme weather events and climate changes that pose the greatest threat to the Old Town and the assessment of its vulnerability to these threats are derived. The dense geometrical characteristics of the city’s structure, the intense pathology observed in the materials and structures of the historic building stock, problems in the existing electromechanical infrastructure, and the poor management of issues such as increased tourism and heavy traffic congestion are the primary factors that make the Old Town of Corfu vulnerable to the effects of climate change. 展开更多
关键词 Historic Settlements Archaeological site VULNERABILITY Climate change Adaptation Strategy
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Compiling and Mapping an International Climate Change Database: Worlds of Gaps and Unevenness
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作者 Stanley D. Brunn 《Natural Resources》 2023年第3期27-44,共18页
Daily and weekly reporting events of climate change and impacts on populations, cultures, economies and politics at local, national, regional and international scales suggest the need to construct databases that will ... Daily and weekly reporting events of climate change and impacts on populations, cultures, economies and politics at local, national, regional and international scales suggest the need to construct databases that will be useful in future scientific inquiry and global human/environmental policies. That need is evident in constructing a geographic or locational knowledge base that examines countries, regions and cities. This study constructs a database on the impacts of climate change using Google Scholar entries for 200 countries and capital cities. A series of maps reveal the vast unevenness in the database, especially between Global North and Global South countries. The discussion explores these sharp differences and suggests future research topics for much-needed global, interdisciplinary and international research. 展开更多
关键词 Climate change Maps capital Cities Knowledge Gaps Climate Impacts Global Climate
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药物临床研究阶段申办者和生产场地变更研究六:临床研究阶段申办者和生产场地跨境变更的风险分析 被引量:1
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作者 陈震 王方敏 +4 位作者 吴正宇 于冰 陈江鹏 高丽萍 杨建红 《中国药事》 CAS 2024年第5期538-548,共11页
目的:通过对临床研究阶段申办者、生产场地发生跨境变更时的风险变化进行分析,为申办者和生产场地的跨境变更管理提供参考。方法:基于申办者和生产场地不同组合情形的初始风险评价结果和采取风险管控措施后的风险再评价结果,比较分析不... 目的:通过对临床研究阶段申办者、生产场地发生跨境变更时的风险变化进行分析,为申办者和生产场地的跨境变更管理提供参考。方法:基于申办者和生产场地不同组合情形的初始风险评价结果和采取风险管控措施后的风险再评价结果,比较分析不同组合情形之间发生变更时变更前后的“风险指数水平”变化。结果与结论:基于初始风险评价结果,有两种变更情形的风险指数水平在变更后较变更前降低;基于风险再评价结果,有四种变更情形的风险指数水平在变更后较变更前降低。 展开更多
关键词 临床研究阶段 申办者 生产场地 跨境变更 风险分析
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电动汽车集中型充电站选址定容模型
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作者 杨亚璪 宾涛 《交通运输系统工程与信息》 EI CSCD 北大核心 2024年第3期204-212,共9页
针对充电和换电等单一模式的盲目建设,规划不集中带来的资源利用率低与部分充电需求得不到满足等问题,本文提出一种考虑充电和换电与移动充电的多种充电模式下集中型充电站选址与定容方法。首先,分析不同类型电动汽车的充电行为特性,模... 针对充电和换电等单一模式的盲目建设,规划不集中带来的资源利用率低与部分充电需求得不到满足等问题,本文提出一种考虑充电和换电与移动充电的多种充电模式下集中型充电站选址与定容方法。首先,分析不同类型电动汽车的充电行为特性,模拟得到规划区域的充电需求分布;然后,基于最近距离原则采用排队论方法计算电动汽车充电损耗成本,优化移动充电设备自充电时刻,求得电动汽车自充电成本;最后,以集中型充电站建设维护成本、用户损失成本及设备自充电成本总和最小为目标建立选址定容模型,结合某城市部分实际道路网为研究区域,采用遗传算法求解模型,确定规划区域内集中型充电站建设数量、位置及不同设备的配置数量。结果表明:规划区域内建设8座集中型充电站总成本达到最低,充电需求车辆数量与充电功率变化对集中型充电站成本均有较大影响,且优化移动充电设备自充电调度管理,可降低集中型充电站高峰时期32.62%的电网负荷,提高了电网稳定性。 展开更多
关键词 交通工程 充电站选址定容 遗传算法 集中型充电站 电动汽车 移动充电
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数字经济如何影响技能工资差距——基于偏向型技术进步的视角
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作者 杨天宇 黄崇乐 《新疆财经》 2024年第3期5-15,共11页
文章基于偏向型技术进步的视角,选取中国家庭追踪调查(CFPS)数据及相关省级面板数据,对数字经济发展和技能工资差距之间的因果关系及其中的作用机制进行了实证检验。结果表明:数字经济发展显著扩大了技能工资差距;数字经济发展主要通过... 文章基于偏向型技术进步的视角,选取中国家庭追踪调查(CFPS)数据及相关省级面板数据,对数字经济发展和技能工资差距之间的因果关系及其中的作用机制进行了实证检验。结果表明:数字经济发展显著扩大了技能工资差距;数字经济发展主要通过促进资本偏向型技术进步、技能偏向型技术进步和提升资本-技能互补性扩大技能工资差距;在数字基础设施较为完善的地区和技能劳动密集型行业中,数字经济发展对扩大技能工资差距的作用更明显。 展开更多
关键词 数字经济 偏向型技术进步 资本-技能互补性 技能工资差距
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明清合浦县学宫的历史沿革与空间演变探析
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作者 吴桂宁 黑箫 《建筑与文化》 2024年第6期195-197,共3页
坐落于合浦廉州古城的合浦县学宫始建于明朝,至今已有600多年的历史。合浦县学宫曾历经多次迁建、重修与损毁,现存的合浦县学宫遗址仅存大成殿。从历代的史料记载中,可推测出合浦县学宫在明清时期的大致建筑空间布局。在史料考证与实物... 坐落于合浦廉州古城的合浦县学宫始建于明朝,至今已有600多年的历史。合浦县学宫曾历经多次迁建、重修与损毁,现存的合浦县学宫遗址仅存大成殿。从历代的史料记载中,可推测出合浦县学宫在明清时期的大致建筑空间布局。在史料考证与实物调查的基础上,挖掘合浦县学宫的历史沿革、选址变迁与空间演变,并探析其营建思想与哲学智慧。 展开更多
关键词 合浦县学宫 历史沿革 选址变迁 空间演变 明清时期
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论资本逻辑对“气候新陈代谢”的撕裂 被引量:1
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作者 张翔 蔡华杰 《福州大学学报(哲学社会科学版)》 2024年第3期10-18,170,共10页
工业革命时期,马克思对受资本主义工业化推动的资本主义农业进行了批判,指明资本主义生产方式不仅扭曲了人与自然的和谐关系,而且与工商业联合起来撕裂了农业生态系统的物质变换,同时这一裂痕随着生态恶化渗透进社会发展的各个领域。进... 工业革命时期,马克思对受资本主义工业化推动的资本主义农业进行了批判,指明资本主义生产方式不仅扭曲了人与自然的和谐关系,而且与工商业联合起来撕裂了农业生态系统的物质变换,同时这一裂痕随着生态恶化渗透进社会发展的各个领域。进入21世纪,资本逻辑主导的“新陈代谢断裂”致使全球气候问题逼近临界阈值,不仅使自然界、劳动者彻底沦为资本增殖的异化工具,更通过气候帝国主义加剧了治理领域的不平等。习近平生态文明思想则从生产、治理、合作三重领域突破了资本主义发展模式禁锢的牢笼,强调营造人与自然和谐共生的良好氛围、致力于构建全人类生态命运共同体、最终实现生态的可持续发展。 展开更多
关键词 资本逻辑 新陈代谢断裂 全球气候变化 习近平生态文明思想
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宁夏黄土区典型坡面表层土壤有机碳含量的空间变化特征及尺度效应
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作者 韩新生 刘广全 +5 位作者 许浩 董立国 郭永忠 安钰 万海霞 王月玲 《林业科学》 EI CAS CSCD 北大核心 2024年第1期19-31,共13页
【目的】定量认识土壤有机碳(SOC)含量在坡面上的空间异质性及尺度效应,探索“由点及面”估算坡面平均SOC含量的精确便捷途径,为细致刻画坡面土壤资源状况、全面理解生态系统碳循环、制定土壤高质量管理方案提供科学基础。【方法】在宁... 【目的】定量认识土壤有机碳(SOC)含量在坡面上的空间异质性及尺度效应,探索“由点及面”估算坡面平均SOC含量的精确便捷途径,为细致刻画坡面土壤资源状况、全面理解生态系统碳循环、制定土壤高质量管理方案提供科学基础。【方法】在宁夏半干旱黄土丘陵区,选择3个相邻的由退耕还林工程形成的典型坡面,从坡顶向坡脚设置连续样点,调查各样点的土地利用、植被特征、立地条件及表层(0^20 cm)SOC含量,分析其坡向差异、坡位变化;以“离坡顶的水平距离或相对距离”为自变量,以表层SOC含量的顺坡滑动平均值为因变量,定量描述坡面尺度效应;再以坡面上任一样点表层SOC含量与坡面平均值的比值为因变量,实现由“点”到“面”的尺度上推。【结果】研究区表层SOC含量存在明显的坡向差异、坡位变化、尺度效应。表层SOC含量的坡面平均值在南坡(7.60 g·kg^(-1))最高,东坡(6.42 g·kg^(-1))次之,西坡(5.65 g·kg^(-1))最低,其坡位间变幅在东坡(15.95 g·kg^(-1))最大,其次为西坡(11.34 g·kg^(-1)),最小为南坡(9.72 g·kg^(-1)),说明东坡的坡面效应最强,其次为西坡,南坡最弱。东坡、西坡、南坡表层SOC含量的坡位变化大致相同,均由坡顶向下逐渐减小,至离坡顶水平距离200、150、280 m(相对距离0.73、0.45、0.76)后趋于稳定,主要与坡面“上部为自然状态的坡地+林草植被+恢复年限长、下部为人工梯田+林农植被+扰动频繁”的空间格局有关。在东坡、西坡、南坡上,距坡顶水平距离每增加100 m,SOC含量的滑动平均值分别变化-3.40、-2.50、-1.51 g·kg^(-1);距坡顶相对距离每增加0.1,SOC含量的滑动平均值分别变化-0.96、-0.75、-0.55 g·kg^(-1)。构建3个坡向不同坡位样点表层SOC含量与坡面平均值的比值随离坡顶水平距离或相对距离增加而变化的数量关系(R^(2)>0.7,P<0.001),籍此可由坡面上任一样点表层SOC含量精确便捷地估算坡面平均值。将所有位点数据融合得出,离坡顶相对距离0.4的位点表层SOC含量最接近坡面平均值。【结论】半干旱黄土丘陵区坡面表层SOC含量沿坡从上至下基本呈先减小后稳定的变化,与土地利用类型、植被类型、恢复年限的坡面分布格局有关。以顺坡(相对)水平坡长增加为尺度变量可较好地定量刻画表层SOC含量的坡面变化特征及尺度效应,藉此可实现坡面表层SOC含量平均值的精确便捷推算。 展开更多
关键词 黄土丘陵区 立地条件 土地利用 土壤有机碳含量 坡面变化 尺度效应
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社会资本参与污染场地修复项目的投融资模式研究
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作者 王宏婕 陶吉 +2 位作者 孙凯成 杜芸 刘碧云 《现代城市研究》 北大核心 2024年第5期124-128,共5页
随着我国城市化进程的加速,产生大量污染场地给人们带来了很多安全隐患,阻碍城市高质量发展。当前污染场地修复多由政府投资为主,社会资本参与的项目数量和程度较低。单纯依靠政府财政难以维系污染场地修复事业的有序发展,在一定程度上... 随着我国城市化进程的加速,产生大量污染场地给人们带来了很多安全隐患,阻碍城市高质量发展。当前污染场地修复多由政府投资为主,社会资本参与的项目数量和程度较低。单纯依靠政府财政难以维系污染场地修复事业的有序发展,在一定程度上影响场地的修复、开发与再利用。文章梳理对比了社会资本参与场地修复的6类投融资模式,分析各模式的资金来源、典型案例、运行机制并评析,旨在为社会资本参与污染场地修复治理实践提供参考。 展开更多
关键词 社会资本 污染场地 土壤修复 投融资模式
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药物临床研究阶段申办者和生产场地变更研究四:我国临床研究阶段申办者和生产场地变更现状调研分析 被引量:3
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作者 于冰 杨建红 +6 位作者 夏雨 李圆圆 顾瑶华 芦臣书 高丽萍 张元媛 王方敏 《中国药事》 CAS 2024年第5期516-525,共10页
目的:梳理我国药物临床试验及临床试验期间变更管理的法规监管要求并对行业现状进行调研,为完善药物临床试验及临床试验期间变更管理的监管体系提供参考。方法:对我国临床试验及其变更的监管法规进行文献研究,对行业现状进行调研,为后... 目的:梳理我国药物临床试验及临床试验期间变更管理的法规监管要求并对行业现状进行调研,为完善药物临床试验及临床试验期间变更管理的监管体系提供参考。方法:对我国临床试验及其变更的监管法规进行文献研究,对行业现状进行调研,为后续完善我国临床试验及临床试验期间变更管理提供参考建议。结果与结论:我国近年来药品审评审批改革不断完善,当前行业发展中存在申办者及生产产地“跨境”及变更的需求。综合考虑创新发展的现实需求和现有法规,在风险可控的条件下,我国已具备一定基础支持临床试验申办者和临床试验药物生产场地的“跨境”及“跨境变更”。 展开更多
关键词 临床试验 变更管理 申办者变更 生产场地变更 药品注册
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药物临床研究阶段申办者和生产场地变更研究二:欧盟药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示 被引量:1
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作者 王宏扬 陈江鹏 +4 位作者 顾瑶华 芦臣书 夏雨 连志荣 吴正宇 《中国药事》 CAS 2024年第5期499-507,共9页
目的:通过法规比较研究分析,为完善我国药物临床试验及临床试验期间变更管理,特别是临床试验期间申办者变更、生产场地变更及其变更管理提供参考。方法:对欧盟药物临床试验申请及临床试验期间变更管理的法规监管要求和实施情况进行研究... 目的:通过法规比较研究分析,为完善我国药物临床试验及临床试验期间变更管理,特别是临床试验期间申办者变更、生产场地变更及其变更管理提供参考。方法:对欧盟药物临床试验申请及临床试验期间变更管理的法规监管要求和实施情况进行研究整理,与我国当前相关监管法规建设和实施现状进行比较分析并提出建议。结果与结论:欧盟允许临床试验申办者和临床试验药物生产场地分属境内、外的临床试验注册申请及变更申请。欧盟临床试验管理制度相对成熟完善,比如其统一的临床试验申请门户网站及临床试验信息数据库、一体化的科学和伦理双重审查并行的审评程序,对申办者及其法定代理人的资质和责任要求、对临床研究用药品生产场地及其变更的监管和风险控制等监管措施,对我国有参考价值。 展开更多
关键词 临床试验 变更管理 申办者变更 生产场地变更 药品监管
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药物临床研究阶段申办者和生产场地变更研究三:美国药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示 被引量:1
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作者 于冰 吴正宇 +2 位作者 陈江鹏 陈园 王方敏 《中国药事》 CAS 2024年第5期508-515,共8页
目的:研究美国药物临床研究期间变更管理的法规监管要求和实施情况,并与我国当前相关监管法规建设和实施现状进行比较,为完善我国药物临床研究期间申办者和生产场地变更管理的监管体系提供参考。方法:对美国临床研究期间申办者和生产场... 目的:研究美国药物临床研究期间变更管理的法规监管要求和实施情况,并与我国当前相关监管法规建设和实施现状进行比较,为完善我国药物临床研究期间申办者和生产场地变更管理的监管体系提供参考。方法:对美国临床研究期间申办者和生产场地变更的监管法规进行系统的梳理研究,结合我国临床研究期间变更管理情况提出建议。结果与结论:美国药物临床试验监管体系采用审批及检查相结合的方式,通过强化申办者负责制,在风险可控的前提下允许申办者及生产场地在不同国家(跨境)的情况存在。我国近年来药品审评审批改革不断深化,在临床研究期间的变更监管体系已初步建立,未来可分阶段细化我国临床试验期间变更的相关要求,以支持产业发展。 展开更多
关键词 临床试验 变更管理 申办者变更 生产场地变更 药品注册
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