美国食品药品监督管理局(Food and Drug Administration,FDA)作为全球药品监管机构的领先者,具备先进的科学和完善的法规体系及合理的机构设置和有效的运行机制。本文针对药品生产质量监管,剖析FDA注册审评、现场检查及合规审评三方面职...美国食品药品监督管理局(Food and Drug Administration,FDA)作为全球药品监管机构的领先者,具备先进的科学和完善的法规体系及合理的机构设置和有效的运行机制。本文针对药品生产质量监管,剖析FDA注册审评、现场检查及合规审评三方面职能,讨论其部门设置和职能划分、运行机制,及资源配置和技术支持,为药监部门加强科学监管提供借鉴,也为企业了解美国FDA药品生产质量监管体系并与其有效沟通提供参考。展开更多
The physical-mechanical,chemical,and durability characteristics of alkali-activated materials(AAMs)have been widely investigated.However,a critical gap in the literature is the lack of a comprehensive overview of rece...The physical-mechanical,chemical,and durability characteristics of alkali-activated materials(AAMs)have been widely investigated.However,a critical gap in the literature is the lack of a comprehensive overview of recently published literature regarding the life cycle assessment(LCA)of these binders.This study aims to fill that gap by conducting a systematic literature review of globally published literature on the topic.This paper consolidates knowledge by searching different databases,focusing on LCA studies that used AAMs as pastes,mortars,concretes,bricks,and rammed earth/soil blocks.The selected articles were reviewed and categorized based on precursors,alkaline activators,functional units,system boundaries,life cycle inventory databases,allocation,impact methodologies,and software used.Additionally,this paper also critically analyzes the key challenges of LCA for AAMs.The major challenges were identified as selecting a functional unit,subjectivity in boundary systems,and data interpretation.This work concludes that AAMs show substantial advantages in global warming potential compared to ordinary Portland cement-based materials;however,the average of other categories such as marine ecotoxicity and ozone layer depletion has been reported to be higher than for the reference samples.展开更多
文摘美国食品药品监督管理局(Food and Drug Administration,FDA)作为全球药品监管机构的领先者,具备先进的科学和完善的法规体系及合理的机构设置和有效的运行机制。本文针对药品生产质量监管,剖析FDA注册审评、现场检查及合规审评三方面职能,讨论其部门设置和职能划分、运行机制,及资源配置和技术支持,为药监部门加强科学监管提供借鉴,也为企业了解美国FDA药品生产质量监管体系并与其有效沟通提供参考。
基金supported by the Alexander von Humboldt Foundation,International Climate Protection Fellowship(Ref 3.5—1157991-IRN-IKS)This financial support is gratefully appreciated by Morteza Nikravan.Rafia Firdous and Dietmar Stephan highly acknowledge Bundesministerium fur Wirtschaft und Energie(BMWi)for funding number 16KN046744.
文摘The physical-mechanical,chemical,and durability characteristics of alkali-activated materials(AAMs)have been widely investigated.However,a critical gap in the literature is the lack of a comprehensive overview of recently published literature regarding the life cycle assessment(LCA)of these binders.This study aims to fill that gap by conducting a systematic literature review of globally published literature on the topic.This paper consolidates knowledge by searching different databases,focusing on LCA studies that used AAMs as pastes,mortars,concretes,bricks,and rammed earth/soil blocks.The selected articles were reviewed and categorized based on precursors,alkaline activators,functional units,system boundaries,life cycle inventory databases,allocation,impact methodologies,and software used.Additionally,this paper also critically analyzes the key challenges of LCA for AAMs.The major challenges were identified as selecting a functional unit,subjectivity in boundary systems,and data interpretation.This work concludes that AAMs show substantial advantages in global warming potential compared to ordinary Portland cement-based materials;however,the average of other categories such as marine ecotoxicity and ozone layer depletion has been reported to be higher than for the reference samples.
