This paper examines the management of hazardous chemicals in Chinese university laboratories,identifying key challenges and proposing improvements.It reviews current practices and safety measures,highlighting deficien...This paper examines the management of hazardous chemicals in Chinese university laboratories,identifying key challenges and proposing improvements.It reviews current practices and safety measures,highlighting deficiencies such as inadequate safety systems and insufficient awareness among personnel.The study emphasizes the necessity of tailored safety management systems,the integration of digital tracking technologies like Radio Frequency Identification,and enhanced safety training for staff.The proposed recommendations aim to mitigate risks and enhance laboratory safety and efficiency.In conclusion,the paper asserts that a comprehensive approach,encompassing improved management systems,technological advancements,and educational initiatives,is essential for safer chemical handling in academic research environments.展开更多
Objective:Limited information is available on the use of dupilumab for the treatment of atopic dermatitis(AD)in the Chinese population.Methods:We analyzed laboratory data from a previously published randomized,double-...Objective:Limited information is available on the use of dupilumab for the treatment of atopic dermatitis(AD)in the Chinese population.Methods:We analyzed laboratory data from a previously published randomized,double-blind phase III trial(NCT03912259)to provide further insight into the safety of dupilumab in Chinese adults with moderate to severe AD.The trial participants received either 300 mg of dupilumab or placebo every 2 weeks for 16 weeks.Hematology,blood chemistry,serum thymus and activation-regulated chemokine(TARC),and total immunoglobulin E(IgE)were evaluated.Results:In total,82 participants received dupilumab and 83 received placebo.With the exception of eosinophil counts of>0.8×109/L,which were found less frequently with dupilumab(9.8%)than with placebo(18.7%),the hematology and blood chemistry values were generally stable in both treatment groups.There were no clinically significant differences between the dupilumab and placebo groups,and no participants developed treatment-emergent abnormalities of potential clinical significance.However,compared with placebo,greater decreases in serum lactate dehydrogenase(mean change,−97.4 vs.−33.5 IU/L),TARC(median percent change,−78.6%vs.−30.8%),and total IgE(median percent change,−53.4%vs.−0.2%)were observed with dupilumab than placebo at week 16.Conclusion:Dupilumab demonstrated a favorable laboratory safety profile in Chinese adults with moderate to severe AD.展开更多
Recently, China National Accreditation Board for Laboratories(CNAL) has released CNAL/AC 23:2004 Medical Laboratories: Accreditation Criteria For Quality and Proficiency, and meanwhile GB 19489 Laboratories: General R...Recently, China National Accreditation Board for Laboratories(CNAL) has released CNAL/AC 23:2004 Medical Laboratories: Accreditation Criteria For Quality and Proficiency, and meanwhile GB 19489 Laboratories: General Requirements For Biosafety and ISO 15190 Medical Laboratories-Requirements For Safety will be adopted by CNAL as the accreditation criteria for laboratories safety.展开更多
Laboratory information management system(LIMS)has been widely used to facilitate laboratory activities.However,the current LIMSs do not contain functions to improve the safety of laboratory work,which is the major con...Laboratory information management system(LIMS)has been widely used to facilitate laboratory activities.However,the current LIMSs do not contain functions to improve the safety of laboratory work,which is the major concern of biosafety laboratories(BSLs).With tons of biosafety information that need to be managed and an increasing number of biosafety-related research projects under way,it is worthy of expanding the current framework of LIMS and building a system that is more suitable for BSL usage.Such a system should carefully trade off between the safety and efficiency of regular lab activities,allowing the laboratory staff to conduct their research as free as possible while ensuring their and the environment’s safety.In order to achieve this goal,the information on the research contents,laboratory personnel,experimental materials and experimental equipment need to be well collected and fully utilized by a centralized system and its databases.展开更多
As the entire world is under the grip of the coronavirus disease 2019(COVID-19),and as many are eagerly trying to explain the origins of the virus and cause of the pandemic,it is imperative to place more attention on ...As the entire world is under the grip of the coronavirus disease 2019(COVID-19),and as many are eagerly trying to explain the origins of the virus and cause of the pandemic,it is imperative to place more attention on related potential biosafety risks.Biology and biotechnology have changed dramatically during the last ten years or so.Their reliance on digitization,automation,and their cyber-overlaps have created new vulnerabilities for unintended consequences and potentials for intended exploitation that are mostly under-appreciated.This study summarizes and elaborates on these new cyberbiosecurity challenges,(1)in terms of comprehending the evolving threat landscape and determining new risk potentials,(2)in developing adequate safeguarding measures,their validation and implementation,and(3)specific critical risks and consequences,many of them unique to the life-sciences.Drawing other's expertise and my previous work,this article reviews and critically interprets our current bio-economy situation.The goal is not to attribute causative aspects of past biosafety or biosecurity events,but to highlight the fact that the bioeconomy harbors unique features that have to be more critically assessed for their potential to unintentionally cause harm to human health or environment,or to be re-tasked with an intention to cause harm.It is concluded with recommendations that will need to be considered to help ensure converging and emerging biorisk challenges,in order to minimize vulnerabilities to the life-science enterprise,public health,and national security.展开更多
文摘This paper examines the management of hazardous chemicals in Chinese university laboratories,identifying key challenges and proposing improvements.It reviews current practices and safety measures,highlighting deficiencies such as inadequate safety systems and insufficient awareness among personnel.The study emphasizes the necessity of tailored safety management systems,the integration of digital tracking technologies like Radio Frequency Identification,and enhanced safety training for staff.The proposed recommendations aim to mitigate risks and enhance laboratory safety and efficiency.In conclusion,the paper asserts that a comprehensive approach,encompassing improved management systems,technological advancements,and educational initiatives,is essential for safer chemical handling in academic research environments.
基金The phase III trial on which this subanalysis is based (NCT03912259) was sponsored by Sanofi. Medical writing assistance with the preparation of this article was also funded by Sanofi.
文摘Objective:Limited information is available on the use of dupilumab for the treatment of atopic dermatitis(AD)in the Chinese population.Methods:We analyzed laboratory data from a previously published randomized,double-blind phase III trial(NCT03912259)to provide further insight into the safety of dupilumab in Chinese adults with moderate to severe AD.The trial participants received either 300 mg of dupilumab or placebo every 2 weeks for 16 weeks.Hematology,blood chemistry,serum thymus and activation-regulated chemokine(TARC),and total immunoglobulin E(IgE)were evaluated.Results:In total,82 participants received dupilumab and 83 received placebo.With the exception of eosinophil counts of>0.8×109/L,which were found less frequently with dupilumab(9.8%)than with placebo(18.7%),the hematology and blood chemistry values were generally stable in both treatment groups.There were no clinically significant differences between the dupilumab and placebo groups,and no participants developed treatment-emergent abnormalities of potential clinical significance.However,compared with placebo,greater decreases in serum lactate dehydrogenase(mean change,−97.4 vs.−33.5 IU/L),TARC(median percent change,−78.6%vs.−30.8%),and total IgE(median percent change,−53.4%vs.−0.2%)were observed with dupilumab than placebo at week 16.Conclusion:Dupilumab demonstrated a favorable laboratory safety profile in Chinese adults with moderate to severe AD.
文摘Recently, China National Accreditation Board for Laboratories(CNAL) has released CNAL/AC 23:2004 Medical Laboratories: Accreditation Criteria For Quality and Proficiency, and meanwhile GB 19489 Laboratories: General Requirements For Biosafety and ISO 15190 Medical Laboratories-Requirements For Safety will be adopted by CNAL as the accreditation criteria for laboratories safety.
文摘Laboratory information management system(LIMS)has been widely used to facilitate laboratory activities.However,the current LIMSs do not contain functions to improve the safety of laboratory work,which is the major concern of biosafety laboratories(BSLs).With tons of biosafety information that need to be managed and an increasing number of biosafety-related research projects under way,it is worthy of expanding the current framework of LIMS and building a system that is more suitable for BSL usage.Such a system should carefully trade off between the safety and efficiency of regular lab activities,allowing the laboratory staff to conduct their research as free as possible while ensuring their and the environment’s safety.In order to achieve this goal,the information on the research contents,laboratory personnel,experimental materials and experimental equipment need to be well collected and fully utilized by a centralized system and its databases.
文摘As the entire world is under the grip of the coronavirus disease 2019(COVID-19),and as many are eagerly trying to explain the origins of the virus and cause of the pandemic,it is imperative to place more attention on related potential biosafety risks.Biology and biotechnology have changed dramatically during the last ten years or so.Their reliance on digitization,automation,and their cyber-overlaps have created new vulnerabilities for unintended consequences and potentials for intended exploitation that are mostly under-appreciated.This study summarizes and elaborates on these new cyberbiosecurity challenges,(1)in terms of comprehending the evolving threat landscape and determining new risk potentials,(2)in developing adequate safeguarding measures,their validation and implementation,and(3)specific critical risks and consequences,many of them unique to the life-sciences.Drawing other's expertise and my previous work,this article reviews and critically interprets our current bio-economy situation.The goal is not to attribute causative aspects of past biosafety or biosecurity events,but to highlight the fact that the bioeconomy harbors unique features that have to be more critically assessed for their potential to unintentionally cause harm to human health or environment,or to be re-tasked with an intention to cause harm.It is concluded with recommendations that will need to be considered to help ensure converging and emerging biorisk challenges,in order to minimize vulnerabilities to the life-science enterprise,public health,and national security.
