Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was us...Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.展开更多
如何确定合适的阈值来区分夜间辐射雾、晴空地表和中高云一直是雾检测研究的重点。圣巴巴拉DISORT大气辐射传输模型(Santa Barbara DISORT atmospheric radiative transfer,SBDART)可模拟雾顶亮度温度。基于该模型获取MODIS B20与B31波...如何确定合适的阈值来区分夜间辐射雾、晴空地表和中高云一直是雾检测研究的重点。圣巴巴拉DISORT大气辐射传输模型(Santa Barbara DISORT atmospheric radiative transfer,SBDART)可模拟雾顶亮度温度。基于该模型获取MODIS B20与B31波段的亮温差(brightness temperature difference,BTD),将其用于夜间辐射雾检测。以MODIS卫星数据为可行性试验数据,用国家卫星气象中心提供的地面验证数据进行验证,结果表明,使用该模型监测夜间雾的准确率达78.3%,误判率为21.7%,可靠性指标为0.643,Kappa系数为0.730。为进一步验证方法的稳定性,选取8景卫星序列图像进行时间序列分析,结果显示Kappa系数均值为0.744,说明应用当前阈值方法对MODIS夜间雾检测具有可适用性。该方法为夜间雾预报和夜间雾参数反演提供了有效的参考。展开更多
With increasing research interests in the field of light-matter interactions,various methods have been developed for regulating nonlinear optical(NLO)materials.However,the design and synthesis of organic molecular mat...With increasing research interests in the field of light-matter interactions,various methods have been developed for regulating nonlinear optical(NLO)materials.However,the design and synthesis of organic molecular materials for second-order nonlinear optics remain a great challenge because of the strict requirement of the materials to possess a noncentrosymmetric structure.In this work,two benzothiadiazole(BTD)derivatives referred to as BTD-H and BTD-F were synthesized,and their NLO properties in the crystalline states were studied.It was found that introducing fluorine into the BTD backbone effectively tuned the crystal packing styles of BTD derivatives to a noncentrosymmetric system for effective second-order NLO responses.Such a strategy to induce the noncentrosymmetric structure by introducing the fluorine atoms and halogen interactions may provide guidance for future engineering of organic NLO molecular materials.展开更多
A novel lubricating oil additive 3-((2-(2-hydroxyethyl)-1,3,2,6-dioxazaborocan-6-yloxy)methyl) benzo[d] thiazole-2(3H)-thione(BTD) was synthesized.The product was characterized by FTIR,elemental analysis,and thermogra...A novel lubricating oil additive 3-((2-(2-hydroxyethyl)-1,3,2,6-dioxazaborocan-6-yloxy)methyl) benzo[d] thiazole-2(3H)-thione(BTD) was synthesized.The product was characterized by FTIR,elemental analysis,and thermogravimetric analysis(TGA).Four-ball tribological tests showed that the addition of a definite concentration of this additive to rapeseed oil could effectively increase both the load-carrying capacity,resistance to wear,and friction-reducing abilities of the oil.Scanning electron microscopy(SEM) observations have confirmed that the additive could result in a reduced diameter of the wear scar.展开更多
基金Special Fund for Academy of Pharmaceutical Regulatory Sciences of Research Base for Drug Regulatory Science of National Medical Products Administration-Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.
文摘如何确定合适的阈值来区分夜间辐射雾、晴空地表和中高云一直是雾检测研究的重点。圣巴巴拉DISORT大气辐射传输模型(Santa Barbara DISORT atmospheric radiative transfer,SBDART)可模拟雾顶亮度温度。基于该模型获取MODIS B20与B31波段的亮温差(brightness temperature difference,BTD),将其用于夜间辐射雾检测。以MODIS卫星数据为可行性试验数据,用国家卫星气象中心提供的地面验证数据进行验证,结果表明,使用该模型监测夜间雾的准确率达78.3%,误判率为21.7%,可靠性指标为0.643,Kappa系数为0.730。为进一步验证方法的稳定性,选取8景卫星序列图像进行时间序列分析,结果显示Kappa系数均值为0.744,说明应用当前阈值方法对MODIS夜间雾检测具有可适用性。该方法为夜间雾预报和夜间雾参数反演提供了有效的参考。
基金supported by China International Science and Technology Project (No. 2016YFE0114900)National Natural Science Foundation of China (No. 21761132007)
文摘With increasing research interests in the field of light-matter interactions,various methods have been developed for regulating nonlinear optical(NLO)materials.However,the design and synthesis of organic molecular materials for second-order nonlinear optics remain a great challenge because of the strict requirement of the materials to possess a noncentrosymmetric structure.In this work,two benzothiadiazole(BTD)derivatives referred to as BTD-H and BTD-F were synthesized,and their NLO properties in the crystalline states were studied.It was found that introducing fluorine into the BTD backbone effectively tuned the crystal packing styles of BTD derivatives to a noncentrosymmetric system for effective second-order NLO responses.Such a strategy to induce the noncentrosymmetric structure by introducing the fluorine atoms and halogen interactions may provide guidance for future engineering of organic NLO molecular materials.
基金supported by the Ministry of Education of Hunan province (09C161,10C0464,and 09C162)
文摘A novel lubricating oil additive 3-((2-(2-hydroxyethyl)-1,3,2,6-dioxazaborocan-6-yloxy)methyl) benzo[d] thiazole-2(3H)-thione(BTD) was synthesized.The product was characterized by FTIR,elemental analysis,and thermogravimetric analysis(TGA).Four-ball tribological tests showed that the addition of a definite concentration of this additive to rapeseed oil could effectively increase both the load-carrying capacity,resistance to wear,and friction-reducing abilities of the oil.Scanning electron microscopy(SEM) observations have confirmed that the additive could result in a reduced diameter of the wear scar.
