Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensi...Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.展开更多
Although China is becoming one of the largest world market for drug sale and usage,new drug development has been behind the developed countries during the past decades.Many newly developed drugs approved in other coun...Although China is becoming one of the largest world market for drug sale and usage,new drug development has been behind the developed countries during the past decades.Many newly developed drugs approved in other countries cannot be easily accessed by patients in China.In addition,there were very few new drugs were approved domestically.To better protect the public health,Chinese government vowed to provide a better environment to encourage new drug development.These include a plan to reform the drug regulation system.As part of the reform,the Center of Drug evaluation(CDE)made great efforts to reform and improve the drug review systems so that new drugs may be go to the market quickly after thorough investigation.The goal of this reform is to establish a drug review system that may be in line with the international standards which are represented by the U.S.FDA,European EMA,and Japanese PDMA.During the past 2 years,great steps were taken on adoption and implantation of guidance released by international organizations,establishment of review teams based on clinical indications,application of advanced review concepts and theories,improvement of established communication system with the Sponsors,modifications on the priority review criteria,and shortening review time,etc.This presentation will focus on the impact of these reform measures on new drug development especially when the Sponsors plans to initiate their clinical studies.展开更多
Cassytha filiformis L,belonging to family Lauraceae,is widely distributed in subtropical and tropical regions.Cassytha filiformis L is a traditional plant medicine in China,it has proved that the plant showed anti-par...Cassytha filiformis L,belonging to family Lauraceae,is widely distributed in subtropical and tropical regions.Cassytha filiformis L is a traditional plant medicine in China,it has proved that the plant showed anti-parasite,anti-tumor,anti-diabetic and anti-platelet aggregation activities,so far,the main pharmacological active components are alkaloids.In this paper,the chemical constituents and pharmacological effects of Cassytha filiformis L were reviewed by referring to databases such as CNKI,Vip and Pubmed,so as to lay a foundation for its development and utilization.展开更多
Tumor vaccines,a type of personalized tumor immunotherapy,have developed rapidly in recent decades.These vaccines evoke tumor antigen-specific T cells to achieve immune recognition and killing of tumor cells.Because t...Tumor vaccines,a type of personalized tumor immunotherapy,have developed rapidly in recent decades.These vaccines evoke tumor antigen-specific T cells to achieve immune recognition and killing of tumor cells.Because the immunogenicity of tumor antigens alone is insufficient,immune adjuvants and nanocarriers are often required to enhance anti-tumor immune responses.At present,vaccine carrier development often integrates nanocarriers and immune adjuvants.Among them,outer membrane vesicles(OMVs)are receiving increasing attention as a delivery platform for tumor vaccines.OMVs are natural nanovesicles derived from Gramnegative bacteria,which have adjuvant function because they contain pathogen associated molecular patterns.Importantly,OMVs can be functionally modified by genetic engineering of bacteria,thus laying a foundation for applications as a delivery platform for tumor nanovaccines.This review summarizes 5 aspects of recent progress in,and future development of,OMV-based tumor nanovaccines:strain selection,heterogeneity,tumor antigen loading,immunogenicity and safety,and mass production of OMVs.展开更多
文摘Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.
文摘Although China is becoming one of the largest world market for drug sale and usage,new drug development has been behind the developed countries during the past decades.Many newly developed drugs approved in other countries cannot be easily accessed by patients in China.In addition,there were very few new drugs were approved domestically.To better protect the public health,Chinese government vowed to provide a better environment to encourage new drug development.These include a plan to reform the drug regulation system.As part of the reform,the Center of Drug evaluation(CDE)made great efforts to reform and improve the drug review systems so that new drugs may be go to the market quickly after thorough investigation.The goal of this reform is to establish a drug review system that may be in line with the international standards which are represented by the U.S.FDA,European EMA,and Japanese PDMA.During the past 2 years,great steps were taken on adoption and implantation of guidance released by international organizations,establishment of review teams based on clinical indications,application of advanced review concepts and theories,improvement of established communication system with the Sponsors,modifications on the priority review criteria,and shortening review time,etc.This presentation will focus on the impact of these reform measures on new drug development especially when the Sponsors plans to initiate their clinical studies.
基金National Natural Science Foundation of China(No.82060778No.81760628)。
文摘Cassytha filiformis L,belonging to family Lauraceae,is widely distributed in subtropical and tropical regions.Cassytha filiformis L is a traditional plant medicine in China,it has proved that the plant showed anti-parasite,anti-tumor,anti-diabetic and anti-platelet aggregation activities,so far,the main pharmacological active components are alkaloids.In this paper,the chemical constituents and pharmacological effects of Cassytha filiformis L were reviewed by referring to databases such as CNKI,Vip and Pubmed,so as to lay a foundation for its development and utilization.
基金supported by grants from the National Key R&D Program of China(Grant No.2021YFA0909900,X.Z.)the CAS Project for Young Scientists in Basic Research(Grant No.YSBR-010,X.Z.)+2 种基金the Beijing Natural Science Foundation(Grant No.Z200020,X.Z.)the Beijing Nova Program(Grant No.Z201100006820031,X.Z.)the National Natural Science Foundation of China(Grant No.32171384,X.Z.).
文摘Tumor vaccines,a type of personalized tumor immunotherapy,have developed rapidly in recent decades.These vaccines evoke tumor antigen-specific T cells to achieve immune recognition and killing of tumor cells.Because the immunogenicity of tumor antigens alone is insufficient,immune adjuvants and nanocarriers are often required to enhance anti-tumor immune responses.At present,vaccine carrier development often integrates nanocarriers and immune adjuvants.Among them,outer membrane vesicles(OMVs)are receiving increasing attention as a delivery platform for tumor vaccines.OMVs are natural nanovesicles derived from Gramnegative bacteria,which have adjuvant function because they contain pathogen associated molecular patterns.Importantly,OMVs can be functionally modified by genetic engineering of bacteria,thus laying a foundation for applications as a delivery platform for tumor nanovaccines.This review summarizes 5 aspects of recent progress in,and future development of,OMV-based tumor nanovaccines:strain selection,heterogeneity,tumor antigen loading,immunogenicity and safety,and mass production of OMVs.
