This study aimed to develop a simple,effective,and accurate internal quality control(IQC)method for therapeutic drug monitoring(TDM)of levetiracetam(LEV)in the serum of patients with epilepsy and to evaluate its perfo...This study aimed to develop a simple,effective,and accurate internal quality control(IQC)method for therapeutic drug monitoring(TDM)of levetiracetam(LEV)in the serum of patients with epilepsy and to evaluate its performance using the Westgard multi-rule criteria,thereby ensuring the analytical quality of the assays.A high-performance liquid chromatography method with diode array detection was established and validated for the quantitative determination of LEV in 100μL of human plasma.Quality control(QC)samples at low,medium,and high concentrations(2.5,10,and 50μg/mL)were prepared in-house,and retrospective IQC data associated with routine TDM of LEV in our laboratory were collected for analysis.Levey-Jennings and Z-score charts were generated using Microsoft Excel,and the TDM assays were assessed according to Westgard multi-rules.Calibration curves demonstrated excellent linearity over a LEV concentration range of 180μg/mL,with correlation coefficients≥0.997 and a lower limit of quantification of 0.5μg/mL.Intra-day and inter-day coefficients of variation for the low,medium,and high concentration QC samples ranged from 1.03%to 6.90%and 1.63%to 8.19%,respectively,while extraction recovery rates were 74.20%83.85%and 70.65%83.72%,respectively.The accuracy of the assay ranged from 96.26%to 109.31%.Twenty batches of QC samples were evaluated using Levey-Jennings and Z-score charts in combination with Westgard multi-rules,and none were found to be out of control.Taken together,this internally developed QC method was simple,rapid,reliable,and accurate for routine TDM of LEV.Its application enhanced the reliability and precision of LEV measurement and supported the rational and safe clinical use of this antiepileptic drug.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
Based on data from China’s A-share listed companies from 2008 to 2017,this paper examines the influence of the contemporary values of Confucianism,namely benevolence,righteousness,propriety,wisdom,and fidelity on the...Based on data from China’s A-share listed companies from 2008 to 2017,this paper examines the influence of the contemporary values of Confucianism,namely benevolence,righteousness,propriety,wisdom,and fidelity on the effectiveness of internal control.It indicates a significant positive correlation between the contemporary values of Confucianism and the effectiveness of internal control.Furthermore,this positive influence is noticeable in family-owned businesses but is unobserved in foreign-invested enterprises in China.In addition,the contemporary values of Confucianism enhance internal control quality through two pathways:promotion incentives and corporate reputation.In regions with lower degrees of openness,lower levels of rule of law and slower marketization,or in companies facing operational crises,the contemporary values of Confucianism have a more pronounced effect on enhancing the effectiveness of internal control.The contemporary values of Confucianism have strengthened the ability of internal control to decrease agency costs and mitigate the negative influence of internal control on risk-taking.展开更多
Annual reports are the main sources of information for outside investors' investment decisions and enable shareholders to supervise the management.Difficulties with the readability of these reports may therefore h...Annual reports are the main sources of information for outside investors' investment decisions and enable shareholders to supervise the management.Difficulties with the readability of these reports may therefore have serious consequences. Using 19,221 firm-year observations of Chinese A-share listed firms from 2001 to 2015, we investigate the association between annual report readability and corporate agency costs, where readability is proxied by report file length and/or file size. We find that firms with better annual report readability experience lower agency costs, and the negative association between readability and agency costs is more pronounced in firms with higher external audit quality, internal control quality or analyst coverage. These results hold after several robustness checks. The positive effect of annual report readability is stronger in private firms than in state-owned enterprises, and becomes stronger after the implementation of new accounting standards in 2007. Readable annual reports can help in monitoring corporate insiders' opportunistic behavior and thus reduce agency costs.展开更多
基金The Support Program Special Grant of Anhui Pharmacist Association(Grant No.SPSG2023001005)the Key Program of Natural Science Research of Higher Education of Anhui Province(Grant No.2023AH052545)。
文摘This study aimed to develop a simple,effective,and accurate internal quality control(IQC)method for therapeutic drug monitoring(TDM)of levetiracetam(LEV)in the serum of patients with epilepsy and to evaluate its performance using the Westgard multi-rule criteria,thereby ensuring the analytical quality of the assays.A high-performance liquid chromatography method with diode array detection was established and validated for the quantitative determination of LEV in 100μL of human plasma.Quality control(QC)samples at low,medium,and high concentrations(2.5,10,and 50μg/mL)were prepared in-house,and retrospective IQC data associated with routine TDM of LEV in our laboratory were collected for analysis.Levey-Jennings and Z-score charts were generated using Microsoft Excel,and the TDM assays were assessed according to Westgard multi-rules.Calibration curves demonstrated excellent linearity over a LEV concentration range of 180μg/mL,with correlation coefficients≥0.997 and a lower limit of quantification of 0.5μg/mL.Intra-day and inter-day coefficients of variation for the low,medium,and high concentration QC samples ranged from 1.03%to 6.90%and 1.63%to 8.19%,respectively,while extraction recovery rates were 74.20%83.85%and 70.65%83.72%,respectively.The accuracy of the assay ranged from 96.26%to 109.31%.Twenty batches of QC samples were evaluated using Levey-Jennings and Z-score charts in combination with Westgard multi-rules,and none were found to be out of control.Taken together,this internally developed QC method was simple,rapid,reliable,and accurate for routine TDM of LEV.Its application enhanced the reliability and precision of LEV measurement and supported the rational and safe clinical use of this antiepileptic drug.
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.
基金supported by project of the National Natural Science Foundation of China(No.71802067).
文摘Based on data from China’s A-share listed companies from 2008 to 2017,this paper examines the influence of the contemporary values of Confucianism,namely benevolence,righteousness,propriety,wisdom,and fidelity on the effectiveness of internal control.It indicates a significant positive correlation between the contemporary values of Confucianism and the effectiveness of internal control.Furthermore,this positive influence is noticeable in family-owned businesses but is unobserved in foreign-invested enterprises in China.In addition,the contemporary values of Confucianism enhance internal control quality through two pathways:promotion incentives and corporate reputation.In regions with lower degrees of openness,lower levels of rule of law and slower marketization,or in companies facing operational crises,the contemporary values of Confucianism have a more pronounced effect on enhancing the effectiveness of internal control.The contemporary values of Confucianism have strengthened the ability of internal control to decrease agency costs and mitigate the negative influence of internal control on risk-taking.
基金support from the Chinese National Science Funds(Grant Nos.71790602 and 71572160)
文摘Annual reports are the main sources of information for outside investors' investment decisions and enable shareholders to supervise the management.Difficulties with the readability of these reports may therefore have serious consequences. Using 19,221 firm-year observations of Chinese A-share listed firms from 2001 to 2015, we investigate the association between annual report readability and corporate agency costs, where readability is proxied by report file length and/or file size. We find that firms with better annual report readability experience lower agency costs, and the negative association between readability and agency costs is more pronounced in firms with higher external audit quality, internal control quality or analyst coverage. These results hold after several robustness checks. The positive effect of annual report readability is stronger in private firms than in state-owned enterprises, and becomes stronger after the implementation of new accounting standards in 2007. Readable annual reports can help in monitoring corporate insiders' opportunistic behavior and thus reduce agency costs.
