Sea surface temperature SST obtained from the initial version of the Korea Operational Oceanographic System（KOOS） SST satellite have low accuracy during summer and daytime. This is attributed to the diurnal warming ...Sea surface temperature SST obtained from the initial version of the Korea Operational Oceanographic System（KOOS） SST satellite have low accuracy during summer and daytime. This is attributed to the diurnal warming effect. Error estimation of SST data must be carried out to use the real-time forecasting numerical model of the KOOS. This study suggests two quality control methods for the KOOS SST system. To minimize the diurnal warming effect, SSTs of areas where wind speed is higher than 5 m/s were used. Depending on the wind threshold value, KOOS SST data for August 2014 were reduced by 0.15°C. Errors in SST data are considered to be a combination of random, sampling, and bias errors. To estimate bias error, the standard deviation of bias between KOOS SSTs and climatology SSTs were used. KOOS SST data yielded an analysis error standard deviation value similar to OSTIA and NOAA NCDC（OISST） data. The KOOS SST shows lower random and sampling errors with increasing number of observations using six satellite datasets. In further studies, the proposed quality control methods for the KOOS SST system will be applied through more long-term case studies and comparisons with other SST systems.展开更多
Mesenchymal stromal cells(MSCs)including mesenchymal stem cells to potentially differentiate into different tissue lineages widely exist in various tissues.In recent years,the clinical research and application of MSCs...Mesenchymal stromal cells(MSCs)including mesenchymal stem cells to potentially differentiate into different tissue lineages widely exist in various tissues.In recent years,the clinical research and application of MSCs have become more extensive,but no standardized guidelines for the preparation and quality control of clinical-grade MSCs currently exist.To standardize the preparation and quality control of MSCs using the human umbilical cord,placenta,bone marrow,and adipose tissue as sample sources for the Chinese Association of Neurorestoratology(CANR;Preparatory)and the China Committee of International Association of Neurorestoratology(IANR-China Committee)member units,this standard is formulated following the T11/CSSCR 001-2017 General Requirements for Stem Cells,Good Manufacturing Practice Pharmaceutical Products(2010 Edition),Pharmacopoeia of the Peopleʹs Republic of China(2015 Edition),Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research(Trial),Code for Cell Banking Facility Quality Management,Sterile Drug Appendix to Pharmaceutical Production Quality Management Regulations,GMP Appendix—Cell Therapy Products(Draft for Comment),The International Society for Cellular Therapy position statement(2006),and Clinical Cell Therapy Guidelines for Neurorestoration(IANR/CANR 2017).Moreover,this standard includes donor evaluation,sample collection,cell preparation,cell inspection,packaging,labeling,transportation and storage,and quality control.It represents the minimum requirements for clinical-grade mesenchymal stromal cell culture and quality control.Moreover,it will be further optimized following the progress of preclinical and clinical research.and consumables that are directly in contact with the cells should be opened and operated in a Grade An environment with a Grade B background[8,10].7.3.5 Samples from different donors or different batches should not be processed continuously in the same operation area to avoid cross-contamination.The workplace should be cleared,and normal ultraviolet disinfection should be carried out after a sample is processed[8].7.3.6 The donorʹs MSC culture shall be managed in a multilevel graded bank(premaster,master,and working cell banks).The cell bank for cellular preparations may be established according to actual conditions[4].7.3.7 After the cell culture in the premaster cell bank is completed according to the actual situation,the peripheral blood of the donor or the donorʹs mother may be collected again for serological testing 3–6 months after the sample collection.Infectious and genetic diseases are followed up.Cell culture for the remaining graded banks is performed after the test and follow-up results meet the requirements.7.3.8 The cell generation of the cell-based medicinal products shall not exceed the maximum allowed by the cell culture process.7.3.9 Cryopreservation of intermediate/final products of cellular preparations in the cell bank requires gradient or program cooling.展开更多
Quality control in disease diagnosis and treatment is critical for ensuring patient safety,optimizing resource utilization,and improving clinical outcomes.In endometrial cancer management,rigorous quality control ensu...Quality control in disease diagnosis and treatment is critical for ensuring patient safety,optimizing resource utilization,and improving clinical outcomes.In endometrial cancer management,rigorous quality control ensures accurate diagnosis through standardized protocols,reducing misdiagnosis and enabling early detection.Treatment is guided by evidence-based guidelines,fostering multi-disciplinary collaboration and minimizing unnecessary variations in care.Quality control also enhances patient safety by reducing medical errors and ensuring compliance with ethical and legal standards.By fostering transparency,professional development,and patient-centered care,it supports the sustainable advancement of healthcare systems,ultimately improving outcomes for patients and the broader medical community.This quality control of endometrial cancer was drafted by the Obstetrics and Gynecology Hospital of Fudan University based on the American Joint Committee on Cancer’s TNM staging(AJCC,8th edition,2017)and the International Federation of Obstetrics and Gynecology’s surgical pathological staging(FIGO,2009).展开更多
Due to the increasingly stringent standards, it is important to assess whether the proposed emission reduction will result in ambient concentrations that meet the standards. The Software for Model Attainment Test-Comm...Due to the increasingly stringent standards, it is important to assess whether the proposed emission reduction will result in ambient concentrations that meet the standards. The Software for Model Attainment Test-Community Edition （SMAT-CE） is developed for demonstrating attainment of air quality standards of O3 and PM2.5. SMAT-CE improves computational efficiency and provides a number of advanced visualization and analytical functionalities on an integrated GIS platform. SMAT-CE incorporates historical measurements of air quality parameters and simulated air pollutant concentrations under a number of emission inventory scenarios to project the level of compliance to air quality standards in a targeted future year. An application case study of the software based on the U.S. National Ambient Air Quality Standards （NAAQS） shows that SMAT-CE is capable of demonstrating the air quality attainment of annual PM2.5 and 8-hour O3 for a proposed emission control policy.展开更多
[Objectives]The paper was to establish the quality standard of Shenqi Qiangjing granules and to conduct routine inspection of granular dosage forms.[Methods]The particle size,moisture,loss on drying,dissolubility,cont...[Objectives]The paper was to establish the quality standard of Shenqi Qiangjing granules and to conduct routine inspection of granular dosage forms.[Methods]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were detected.Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis were qualitatively identified by thin layer chromatography(TLC).[Results]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were all in line with the relevant regulations of Pharmacopoeia of the People's Republic of China(2020 edition).Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis had clear fluorescent spots in TLC assay,and no such spots were found in negative control.[Conclusions]The method has the advantages of simple operation,accurate and reliable results,strong specificity and good repeatability,and can effectively control the quality of Shenqi Qiangjing granules.展开更多
The setting-up of the Malaysian Audit Oversight Board （AOB） in 2010 under the Securities Commission Amendment Act 2010 has extended the role of regulators into the statutory audit domain for public listed companies....The setting-up of the Malaysian Audit Oversight Board （AOB） in 2010 under the Securities Commission Amendment Act 2010 has extended the role of regulators into the statutory audit domain for public listed companies. Although the auditing profession in Malaysia has International Auditing Standards as prescribed minimum level of quality in the delivery of audit assurance services, self-regulation by the profession alone appears inadequate to ensure the delivery of quality audit services. With co-regulation, auditors now are monitored not just by the profession but also by a new statutory body with considerable regulatory powers to sanction auditors where quality of the audit process has been found wanting. This study solicits the opinions of auditors on their expectations of what the new regulator can achieve. Based on interviews with a sample of 30 auditors, the study finds that the majority believe that audit quality will be taken to a new level following AOB＇s remit of registration of auditors, compliance inspection with International Standard on Quality Control （ISQC）, monitoring of financial statement quality, and its power of sanctions. A review of AOB＇s early years＇ inspection confirms these expectations.展开更多
基金A part of the projects titled "Development of Korea Operational Oceanographic System(KOOS),Phase 2","Construction of Ocean Research Stations and their Application Studies","Development of Environmental Information System for NSR Navigation" funded by the Ministry of Oceans and Fisheries,Korea,and "Development of fundamental technology for coastal erosion control" of KIOST
文摘Sea surface temperature SST obtained from the initial version of the Korea Operational Oceanographic System（KOOS） SST satellite have low accuracy during summer and daytime. This is attributed to the diurnal warming effect. Error estimation of SST data must be carried out to use the real-time forecasting numerical model of the KOOS. This study suggests two quality control methods for the KOOS SST system. To minimize the diurnal warming effect, SSTs of areas where wind speed is higher than 5 m/s were used. Depending on the wind threshold value, KOOS SST data for August 2014 were reduced by 0.15°C. Errors in SST data are considered to be a combination of random, sampling, and bias errors. To estimate bias error, the standard deviation of bias between KOOS SSTs and climatology SSTs were used. KOOS SST data yielded an analysis error standard deviation value similar to OSTIA and NOAA NCDC（OISST） data. The KOOS SST shows lower random and sampling errors with increasing number of observations using six satellite datasets. In further studies, the proposed quality control methods for the KOOS SST system will be applied through more long-term case studies and comparisons with other SST systems.
文摘Mesenchymal stromal cells(MSCs)including mesenchymal stem cells to potentially differentiate into different tissue lineages widely exist in various tissues.In recent years,the clinical research and application of MSCs have become more extensive,but no standardized guidelines for the preparation and quality control of clinical-grade MSCs currently exist.To standardize the preparation and quality control of MSCs using the human umbilical cord,placenta,bone marrow,and adipose tissue as sample sources for the Chinese Association of Neurorestoratology(CANR;Preparatory)and the China Committee of International Association of Neurorestoratology(IANR-China Committee)member units,this standard is formulated following the T11/CSSCR 001-2017 General Requirements for Stem Cells,Good Manufacturing Practice Pharmaceutical Products(2010 Edition),Pharmacopoeia of the Peopleʹs Republic of China(2015 Edition),Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research(Trial),Code for Cell Banking Facility Quality Management,Sterile Drug Appendix to Pharmaceutical Production Quality Management Regulations,GMP Appendix—Cell Therapy Products(Draft for Comment),The International Society for Cellular Therapy position statement(2006),and Clinical Cell Therapy Guidelines for Neurorestoration(IANR/CANR 2017).Moreover,this standard includes donor evaluation,sample collection,cell preparation,cell inspection,packaging,labeling,transportation and storage,and quality control.It represents the minimum requirements for clinical-grade mesenchymal stromal cell culture and quality control.Moreover,it will be further optimized following the progress of preclinical and clinical research.and consumables that are directly in contact with the cells should be opened and operated in a Grade An environment with a Grade B background[8,10].7.3.5 Samples from different donors or different batches should not be processed continuously in the same operation area to avoid cross-contamination.The workplace should be cleared,and normal ultraviolet disinfection should be carried out after a sample is processed[8].7.3.6 The donorʹs MSC culture shall be managed in a multilevel graded bank(premaster,master,and working cell banks).The cell bank for cellular preparations may be established according to actual conditions[4].7.3.7 After the cell culture in the premaster cell bank is completed according to the actual situation,the peripheral blood of the donor or the donorʹs mother may be collected again for serological testing 3–6 months after the sample collection.Infectious and genetic diseases are followed up.Cell culture for the remaining graded banks is performed after the test and follow-up results meet the requirements.7.3.8 The cell generation of the cell-based medicinal products shall not exceed the maximum allowed by the cell culture process.7.3.9 Cryopreservation of intermediate/final products of cellular preparations in the cell bank requires gradient or program cooling.
基金National Natural Science Foundation of China(82273233)Natural Science Foundation of Shanghai(22ZR1408900)Clinical Research Plan of SHDC(SHDC2020CR4079)。
文摘Quality control in disease diagnosis and treatment is critical for ensuring patient safety,optimizing resource utilization,and improving clinical outcomes.In endometrial cancer management,rigorous quality control ensures accurate diagnosis through standardized protocols,reducing misdiagnosis and enabling early detection.Treatment is guided by evidence-based guidelines,fostering multi-disciplinary collaboration and minimizing unnecessary variations in care.Quality control also enhances patient safety by reducing medical errors and ensuring compliance with ethical and legal standards.By fostering transparency,professional development,and patient-centered care,it supports the sustainable advancement of healthcare systems,ultimately improving outcomes for patients and the broader medical community.This quality control of endometrial cancer was drafted by the Obstetrics and Gynecology Hospital of Fudan University based on the American Joint Committee on Cancer’s TNM staging(AJCC,8th edition,2017)and the International Federation of Obstetrics and Gynecology’s surgical pathological staging(FIGO,2009).
基金provided by the U.S. Environmental Protection Agency (Subcontract Number OR13810-001.04 A10-0223-S001-A04)partly supported by the funding of Guangdong Provincial Key Laboratory of Atmospheric Environment and Pollution Control (No. 2011A060901011)+1 种基金the funding of State Environmental Protection Key Laboratory of Sources and Control of Air Pollution Complex (No. SCAPC201308)the project of Atmospheric Haze Collaborative Control System Design (No. XDB05030400) from Chinese Academy of Sciences
文摘Due to the increasingly stringent standards, it is important to assess whether the proposed emission reduction will result in ambient concentrations that meet the standards. The Software for Model Attainment Test-Community Edition （SMAT-CE） is developed for demonstrating attainment of air quality standards of O3 and PM2.5. SMAT-CE improves computational efficiency and provides a number of advanced visualization and analytical functionalities on an integrated GIS platform. SMAT-CE incorporates historical measurements of air quality parameters and simulated air pollutant concentrations under a number of emission inventory scenarios to project the level of compliance to air quality standards in a targeted future year. An application case study of the software based on the U.S. National Ambient Air Quality Standards （NAAQS） shows that SMAT-CE is capable of demonstrating the air quality attainment of annual PM2.5 and 8-hour O3 for a proposed emission control policy.
基金Supported by Guangxi Key Research and Development Project(GK AB2203-5073)Guangxi TCM Appropriate Technology Development and Promotion Project(GZSY22-18)Research Project of Guangxi Administration of Traditional Chinese Medicine(GXZYZ20210209,GXZYA20220180).
文摘[Objectives]The paper was to establish the quality standard of Shenqi Qiangjing granules and to conduct routine inspection of granular dosage forms.[Methods]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were detected.Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis were qualitatively identified by thin layer chromatography(TLC).[Results]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were all in line with the relevant regulations of Pharmacopoeia of the People's Republic of China(2020 edition).Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis had clear fluorescent spots in TLC assay,and no such spots were found in negative control.[Conclusions]The method has the advantages of simple operation,accurate and reliable results,strong specificity and good repeatability,and can effectively control the quality of Shenqi Qiangjing granules.
文摘The setting-up of the Malaysian Audit Oversight Board （AOB） in 2010 under the Securities Commission Amendment Act 2010 has extended the role of regulators into the statutory audit domain for public listed companies. Although the auditing profession in Malaysia has International Auditing Standards as prescribed minimum level of quality in the delivery of audit assurance services, self-regulation by the profession alone appears inadequate to ensure the delivery of quality audit services. With co-regulation, auditors now are monitored not just by the profession but also by a new statutory body with considerable regulatory powers to sanction auditors where quality of the audit process has been found wanting. This study solicits the opinions of auditors on their expectations of what the new regulator can achieve. Based on interviews with a sample of 30 auditors, the study finds that the majority believe that audit quality will be taken to a new level following AOB＇s remit of registration of auditors, compliance inspection with International Standard on Quality Control （ISQC）, monitoring of financial statement quality, and its power of sanctions. A review of AOB＇s early years＇ inspection confirms these expectations.
