Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health t...Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health testing,as well as a big data platform for the health and safety evaluation of special medical foods.Methods:The Delphi method was used to conduct two rounds of expert consultation on the constructed FSMP health effect evaluation indicators.Results:Ten major items were identified after two rounds of expert consultation.Among these,there were 10 primary entries,32 secondary entries,50 tertiary entries,and 28 quaternary entries.Conclusion:The complete list of evaluation indicators contains 10 entries,which can comprehensively and systematically monitor adverse reactions to the use of FSMPs.The present findings lay the foundation for a big data platform to evaluate the health and safety of special foods.展开更多
In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production si...In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production sites,equipment facilities,equipment layout,technological process,personnel management,management system and supplementary rules are interpreted item by item.This study has important value and historical significance for promoting the development of Chinese enterprises and industries of foods for special medical purposes.展开更多
Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain m...Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain multiple related targets and an appropriate combination can maximize benefits while minimizing adverse reactions.As such,it is especially important to derive mathematical models for their quantitative calculation.In this paper,we introduce mathematical rules for the synergistic,additive,and antagonistic effects of multi-drug combinations developed in our laboratory.We have established a“onebelt,one-line”model and provide examples of the quantitative calculation of the synergistic,additive,and antagonistic effects of a combination of multiple components.We also explain how to scientifically and precisely determine the intensity of these synergies,additions and antagonisms,as well as their corresponding dose ranges,thereby laying a solid theoretical foundation for market listing combinatorial drugs and foods for special medical purposes.展开更多
目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、...目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、解读和说明;从产品数量、产品类型、适用人群等方面对已批复特殊医学用途配方食品进行总结分析。结果:特殊医学用途配方食品已形成相对完善的标准和法律法规体系;截至2024年3月,特殊医学用途配方食品已注册181个产品。结论:特殊医学用途配方食品标准和法律法规是产品研发生产、注册审批及临床使用的依据,FSMP的批复信息是产品研发、临床应用的重要参考信息,应加强了解和掌握,促进FSMP的研究开发和临床应用。展开更多
基金This research was supported by the National Key Research and Development Program of China(2019YFC1606400).
文摘Objective:The Delphi method was used to propose health effect evaluation indicators to assess foods for special medical purposes(FSMPs).This lays the foundation for the formation of a big data model for human health testing,as well as a big data platform for the health and safety evaluation of special medical foods.Methods:The Delphi method was used to conduct two rounds of expert consultation on the constructed FSMP health effect evaluation indicators.Results:Ten major items were identified after two rounds of expert consultation.Among these,there were 10 primary entries,32 secondary entries,50 tertiary entries,and 28 quaternary entries.Conclusion:The complete list of evaluation indicators contains 10 entries,which can comprehensively and systematically monitor adverse reactions to the use of FSMPs.The present findings lay the foundation for a big data platform to evaluate the health and safety of special foods.
基金The authors acknowledge the support from“National Key R&D Program of China”(Project No.2018YFC1603400).
文摘In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production sites,equipment facilities,equipment layout,technological process,personnel management,management system and supplementary rules are interpreted item by item.This study has important value and historical significance for promoting the development of Chinese enterprises and industries of foods for special medical purposes.
文摘Multi-drug(or multi-element)combinations are often prescribed in the practice of clinical medicine and as foods for special medical purposes.The main motivations for these combinations are that most diseases contain multiple related targets and an appropriate combination can maximize benefits while minimizing adverse reactions.As such,it is especially important to derive mathematical models for their quantitative calculation.In this paper,we introduce mathematical rules for the synergistic,additive,and antagonistic effects of multi-drug combinations developed in our laboratory.We have established a“onebelt,one-line”model and provide examples of the quantitative calculation of the synergistic,additive,and antagonistic effects of a combination of multiple components.We also explain how to scientifically and precisely determine the intensity of these synergies,additions and antagonisms,as well as their corresponding dose ranges,thereby laying a solid theoretical foundation for market listing combinatorial drugs and foods for special medical purposes.
文摘目的:梳理特殊医学用途配方食品(Food for Special Medical Purpose,FSMP)的法规标准,汇总分析已获批产品的相关信息,为产品研发、申请注册、临床使用等提供参考。方法:从管理和应用的角度,对与FSMP密切相关的法律法规、标准进行汇总、解读和说明;从产品数量、产品类型、适用人群等方面对已批复特殊医学用途配方食品进行总结分析。结果:特殊医学用途配方食品已形成相对完善的标准和法律法规体系;截至2024年3月,特殊医学用途配方食品已注册181个产品。结论:特殊医学用途配方食品标准和法律法规是产品研发生产、注册审批及临床使用的依据,FSMP的批复信息是产品研发、临床应用的重要参考信息,应加强了解和掌握,促进FSMP的研究开发和临床应用。
