目的分析中国加入国际人用药品注册技术协调会(ICH)后,国内企业仿制药中美双报注册的现状及其注册要求,以期为国内企业提供参考。方法比较分析中国和美国化学仿制药注册申报路径、通用技术文档(common technical document,CTD)、药学研...目的分析中国加入国际人用药品注册技术协调会(ICH)后,国内企业仿制药中美双报注册的现状及其注册要求,以期为国内企业提供参考。方法比较分析中国和美国化学仿制药注册申报路径、通用技术文档(common technical document,CTD)、药学研究和生物等效性研究等方面的具体要求,总结我国企业中美双报的优势和劣势,强调中美双报过程中需要关注的重点。结果2017年以来,国内企业在美国的仿制药申请(abbreviated new drug application,ANDA)获批数量显著增加;中美仿制药注册在CTD申报的要求、药学研究资料、生物等效性试验的设计等方面有差异也有共性,国内企业在注册申报时需对这些差异予以重视,深入理解两国的技术要求。结论从研发立项、质量标准、参比制剂选择、生物等效性试验设计等方面分别提出了建议,以期为我国企业中美双报提供参考,加快药品在两国上市速度,提升国内企业的国际竞争力。展开更多
As the world’s top two economies,the United States(U.S.)and China face a number of similar water resources problems.Yet,few studies have been done to systematically compare policies and approaches on water resources ...As the world’s top two economies,the United States(U.S.)and China face a number of similar water resources problems.Yet,few studies have been done to systematically compare policies and approaches on water resources management between China and the U.S.This study compares water resources policies of China and the U.S.in the areas of national authority,water supply,water quality,and ecosystem use of the water to draw lessons learned and shed light on water resources management in China,the U.S.,and the rest of the world.The lessons learned from the comparison include six aspects.1)New paradigms of people-water harmony and a water-saving society are urgently needed to address the pressing water crisis and achieve the United Nations Sustainable Development Goals(UN SDGs).2)A comprehensive,consistent,forward-looking national policy is necessary to achieve sustainable use of water resources.3)Empowerment of river basin commissions with comprehensive authority over the integrative management of air,land,water,and biological resources in the river basin could significantly enhance the benefits and effectiveness of economic development and environmental protection.4)Expansion of water exchange through market mechanisms among water users promotes efficient and beneficial water uses.5)Use of water for ecosystem services should be an integral part of water resources management.China has set up a national blueprint for achieving ecological civilization;maintaining appropriate amounts of flow in rivers and lakes for maintenance of wildlife and fisheries and ecosystems should be institutionalized as part of this national strategy as well.6)By sharing their rich experiences and lessons in water resources management,economic development,and ecological protection with other countries,China and the U.S.can help the world to achieve global human-water harmony and the UN SDGs.展开更多
AIM: To compare the racial differences of anatomical distribution of colorectal cancer (CRC) and determine the association of age, gender and time with anatomical distribution between patients from America (white) and...AIM: To compare the racial differences of anatomical distribution of colorectal cancer (CRC) and determine the association of age, gender and time with anatomical distribution between patients from America (white) and China (oriental).METHODS: Data was collected from 690 consecutive patients in Cleveland Clinic Florida, U.S.A. and 870consecutive patients in Nan Fang Hospital affiliated to the First Military Medical University, China over the past 11years from 1990 to 2000. All patients had colorectal adenocarcinoma diagnosed by histology and underwent surgery.RESULTS: The anatomical subsite distribution of tumor,age and gender were significantly different between white and oriental patients. Lesions in the proximal colon (P<0.001) were found in 36.3 % of white vs 26.0 % of oriental patients and cancers located in the distal colon and rectum in 63.7 % of white and 74 % of oriental patients (P<0.001). There was a trend towards the redistribution from distal colon and rectum to proximal colon in white males over time, especially in older patients (>80 years).No significant change of anatomical distribution occurred in white women and Oriental patients. The mean age at diagnosis was 69.0 years in white patients and 48.3 years in Oriental patients (P<0.001).CONCLUSION: This is the first study comparing the anatomical distribution of colorectal cancers in whites and Chinese patients. White Americans have a higher risk of proximal CRC and this risk increased with time. The proportion of white males with CRC also increased with time.Chinese patients were more likely to have distal CRC and developed the disease at a significantly earlier age than white patients. These findings have enhanced our understanding of the disease process of colorectal cancer in these two races.展开更多
China and the United States are the two most significant nations in the contemporary global food and agricultural network.In addition,they are two of the most important innovators with respect to the development of ne...China and the United States are the two most significant nations in the contemporary global food and agricultural network.In addition,they are two of the most important innovators with respect to the development of new crop varieties,agro-technologies,farm products,markets and consumer issues,such as consumer resistance to genetically modified foods,among others.In the face of an ever-complex web of interactions,technologies and products among producers and consumers in both nations,there are far more structural similarities than differences in the food and agriculture sectors of these two nations.This essay,adopting some of the themes of the Sino-American Symposium on Future Issues Affecting Quality of Life,presents a limited but representative comparative assessment of three of the most important shared challenges impacting the agricultural sectors of China and the United States for the period from 2000 to the present including 1)environmental challenges related to agricultural water supply,2)declines in farm labor and rural population,and 3)growing food-related concerns and challenges.For both nations,excessive and unsustainable groundwater consumption has lowered water tables and limited crop production.Rural populations and farm workforces in both nations are also declining,leading to labor challenges in both nations.Finally,concerns regarding food safety are also very similar with major challenges to the farm sector associated with consumer resistance to genetically modified food crops and sanitation issues linked to lengthening supply chains.All of these issues threaten the development of sustainable agricultural production systems.展开更多
Many energy consuming countries have carried out research, development, demonstration, planning and deployment of coal-to-liquids (CTL) because of its ability to replace oil imports by converting coal resources into f...Many energy consuming countries have carried out research, development, demonstration, planning and deployment of coal-to-liquids (CTL) because of its ability to replace oil imports by converting coal resources into fuel. Among them, China and South Africa successfully had their CTL technology industrialized, while the United States did not. To understand the differences in the industrial development level, a comparative study is necessary. This paper compares the history, driver and policy of CTL industry in China, South Africa and United States, collates and discloses numbers of industry details for the first time. We figure out that the motivation, top level planning and policy consistency are the key indicators of the difference on the industrial development level. Among them, the key to the success of CTL industrialization in China and South Africa is the government’s strong and stable determination to improve energy security, which provides a stable top-level planning and robust policy support. The failure of CTL in United States is caused by the shift of policy attention after its energy security situation improved.展开更多
It is well-known that the United States,a highly developed country whether in high-tech.or higher education,is in a leading position in the world.Based on the comparison and analysis of higher education between China ...It is well-known that the United States,a highly developed country whether in high-tech.or higher education,is in a leading position in the world.Based on the comparison and analysis of higher education between China and the U.S.,this article highly affirms the advantages of American higher education,offers an objective comment on China's higher education reform in recent years,and earnestly indicates that China's higher education needs to be improved in order to facilitate greater development.展开更多
Language is a carrier of culture and a comparative study of the source language and the target language in translation will reflect the differences and similarities of two cultures.Due to different socio-cultural back...Language is a carrier of culture and a comparative study of the source language and the target language in translation will reflect the differences and similarities of two cultures.Due to different socio-cultural backgrounds and distinctive characteristics of Chinese and English,some concepts about culture are accordingly expressed and translated differently,and it is worthwhile to reflect on these concepts from a cross-disciplinary perspective,such as State and Guojia.The paper tries to explore the connotations of Guo,Jia,Guojia and State,and illustrates how different culture origins results in incomplete equivalence in translation,which can be regarded as a blessing in the times of culture diversity.展开更多
文摘目的分析中国加入国际人用药品注册技术协调会(ICH)后,国内企业仿制药中美双报注册的现状及其注册要求,以期为国内企业提供参考。方法比较分析中国和美国化学仿制药注册申报路径、通用技术文档(common technical document,CTD)、药学研究和生物等效性研究等方面的具体要求,总结我国企业中美双报的优势和劣势,强调中美双报过程中需要关注的重点。结果2017年以来,国内企业在美国的仿制药申请(abbreviated new drug application,ANDA)获批数量显著增加;中美仿制药注册在CTD申报的要求、药学研究资料、生物等效性试验的设计等方面有差异也有共性,国内企业在注册申报时需对这些差异予以重视,深入理解两国的技术要求。结论从研发立项、质量标准、参比制剂选择、生物等效性试验设计等方面分别提出了建议,以期为我国企业中美双报提供参考,加快药品在两国上市速度,提升国内企业的国际竞争力。
文摘As the world’s top two economies,the United States(U.S.)and China face a number of similar water resources problems.Yet,few studies have been done to systematically compare policies and approaches on water resources management between China and the U.S.This study compares water resources policies of China and the U.S.in the areas of national authority,water supply,water quality,and ecosystem use of the water to draw lessons learned and shed light on water resources management in China,the U.S.,and the rest of the world.The lessons learned from the comparison include six aspects.1)New paradigms of people-water harmony and a water-saving society are urgently needed to address the pressing water crisis and achieve the United Nations Sustainable Development Goals(UN SDGs).2)A comprehensive,consistent,forward-looking national policy is necessary to achieve sustainable use of water resources.3)Empowerment of river basin commissions with comprehensive authority over the integrative management of air,land,water,and biological resources in the river basin could significantly enhance the benefits and effectiveness of economic development and environmental protection.4)Expansion of water exchange through market mechanisms among water users promotes efficient and beneficial water uses.5)Use of water for ecosystem services should be an integral part of water resources management.China has set up a national blueprint for achieving ecological civilization;maintaining appropriate amounts of flow in rivers and lakes for maintenance of wildlife and fisheries and ecosystems should be institutionalized as part of this national strategy as well.6)By sharing their rich experiences and lessons in water resources management,economic development,and ecological protection with other countries,China and the U.S.can help the world to achieve global human-water harmony and the UN SDGs.
文摘AIM: To compare the racial differences of anatomical distribution of colorectal cancer (CRC) and determine the association of age, gender and time with anatomical distribution between patients from America (white) and China (oriental).METHODS: Data was collected from 690 consecutive patients in Cleveland Clinic Florida, U.S.A. and 870consecutive patients in Nan Fang Hospital affiliated to the First Military Medical University, China over the past 11years from 1990 to 2000. All patients had colorectal adenocarcinoma diagnosed by histology and underwent surgery.RESULTS: The anatomical subsite distribution of tumor,age and gender were significantly different between white and oriental patients. Lesions in the proximal colon (P<0.001) were found in 36.3 % of white vs 26.0 % of oriental patients and cancers located in the distal colon and rectum in 63.7 % of white and 74 % of oriental patients (P<0.001). There was a trend towards the redistribution from distal colon and rectum to proximal colon in white males over time, especially in older patients (>80 years).No significant change of anatomical distribution occurred in white women and Oriental patients. The mean age at diagnosis was 69.0 years in white patients and 48.3 years in Oriental patients (P<0.001).CONCLUSION: This is the first study comparing the anatomical distribution of colorectal cancers in whites and Chinese patients. White Americans have a higher risk of proximal CRC and this risk increased with time. The proportion of white males with CRC also increased with time.Chinese patients were more likely to have distal CRC and developed the disease at a significantly earlier age than white patients. These findings have enhanced our understanding of the disease process of colorectal cancer in these two races.
文摘China and the United States are the two most significant nations in the contemporary global food and agricultural network.In addition,they are two of the most important innovators with respect to the development of new crop varieties,agro-technologies,farm products,markets and consumer issues,such as consumer resistance to genetically modified foods,among others.In the face of an ever-complex web of interactions,technologies and products among producers and consumers in both nations,there are far more structural similarities than differences in the food and agriculture sectors of these two nations.This essay,adopting some of the themes of the Sino-American Symposium on Future Issues Affecting Quality of Life,presents a limited but representative comparative assessment of three of the most important shared challenges impacting the agricultural sectors of China and the United States for the period from 2000 to the present including 1)environmental challenges related to agricultural water supply,2)declines in farm labor and rural population,and 3)growing food-related concerns and challenges.For both nations,excessive and unsustainable groundwater consumption has lowered water tables and limited crop production.Rural populations and farm workforces in both nations are also declining,leading to labor challenges in both nations.Finally,concerns regarding food safety are also very similar with major challenges to the farm sector associated with consumer resistance to genetically modified food crops and sanitation issues linked to lengthening supply chains.All of these issues threaten the development of sustainable agricultural production systems.
文摘Many energy consuming countries have carried out research, development, demonstration, planning and deployment of coal-to-liquids (CTL) because of its ability to replace oil imports by converting coal resources into fuel. Among them, China and South Africa successfully had their CTL technology industrialized, while the United States did not. To understand the differences in the industrial development level, a comparative study is necessary. This paper compares the history, driver and policy of CTL industry in China, South Africa and United States, collates and discloses numbers of industry details for the first time. We figure out that the motivation, top level planning and policy consistency are the key indicators of the difference on the industrial development level. Among them, the key to the success of CTL industrialization in China and South Africa is the government’s strong and stable determination to improve energy security, which provides a stable top-level planning and robust policy support. The failure of CTL in United States is caused by the shift of policy attention after its energy security situation improved.
文摘It is well-known that the United States,a highly developed country whether in high-tech.or higher education,is in a leading position in the world.Based on the comparison and analysis of higher education between China and the U.S.,this article highly affirms the advantages of American higher education,offers an objective comment on China's higher education reform in recent years,and earnestly indicates that China's higher education needs to be improved in order to facilitate greater development.
基金part of the results of the Key Humanities and Social Science Project from the Educational Department of Hubei Province in 2014(No.14D053)
文摘Language is a carrier of culture and a comparative study of the source language and the target language in translation will reflect the differences and similarities of two cultures.Due to different socio-cultural backgrounds and distinctive characteristics of Chinese and English,some concepts about culture are accordingly expressed and translated differently,and it is worthwhile to reflect on these concepts from a cross-disciplinary perspective,such as State and Guojia.The paper tries to explore the connotations of Guo,Jia,Guojia and State,and illustrates how different culture origins results in incomplete equivalence in translation,which can be regarded as a blessing in the times of culture diversity.