Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the m...Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws.Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system.We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system,which includes building a sound pharmacovigilance organizational structure,establishing a series of operational system files and cultivating professional talents.MAHs of China should improve the structure of enterprise pharmacovigilance system.Besides,members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment.If MAHs possess a large variety and quantity of products,a Drug Safety Committee should be established to ensure the timely discovery of risks.In addition,MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant,effective and operatable files combing with the actual operation of pharmacovigilance system.Finally,MAHs should introduce and train pharmacovigilance talents,and hire pharmacovigilance experts as consultants to solve the problem of talent shortage.展开更多
For eliminating the zero-order image in digital holography, a new method using the differential of the hologram intensity instead of the hologram itself for numerical reconstruction is proposed. This method is based o...For eliminating the zero-order image in digital holography, a new method using the differential of the hologram intensity instead of the hologram itself for numerical reconstruction is proposed. This method is based on digital image processing. By analyzing the spatial spectrum of the off-axis digital hologram, it theoretically proves that the zero-order image can be effectively eliminated by differential before reconstruction. Then, the detected hologram is processed in the program with differential and reconstruction. Both the theoretical analysis and digital reconstruction results show that it can effectively eliminate the large bright spot in the center of the reconstructed image caused by the zero-order image, improve the image quality significantly, and render a better contrast of the reconstructed image. This method is very simple and convenient due to no superfluous optical elements and requiring only one time record.展开更多
Shell structures have increasingly widespread applications in biomedical ultrasound fields such as contrast agents and drug delivery,which requires the precise prediction of the acoustic radiation force under various ...Shell structures have increasingly widespread applications in biomedical ultrasound fields such as contrast agents and drug delivery,which requires the precise prediction of the acoustic radiation force under various circumstances to improve the system efficiency.The acoustic radiation force exerted by a zero-order quasi-Bessel-Gauss beam on an elastic spherical shell near an impedance boundary is theoretically and numerically studied in this study.By means of the finite series method and the image theory,a zero-order quasi-Bessel-Gauss beam is expanded in terms of spherical harmonic functions,and the exact solution of the acoustic radiation force is derived based on the acoustic scattering theory.The acoustic radiation force function,which represents the radiation force per unit energy density and per unit cross-sectional surface,is especially investigated.Some simulated results for a polymethyl methacrylate shell and an aluminum shell are provided to illustrate the behavior of acoustic radiation force in this case.The simulated results show the oscillatory property and the negative radiation force caused by the impedance boundary.An appropriate relative thickness of the shell can generate sharp peaks for a polymethyl methacrylate shell.Strong radiation force can be obtained at small half-cone angles and the beam waist only affects the results at high frequencies.Considering that the quasi-Bessel-Gauss beam possesses both the energy focusing property and the non-diffracting advantage,this study is expected to be useful in the development of acoustic tweezers,contrast agent micro-shells,and drug delivery applications.展开更多
In this research, we have improved a relaxation method for triangular meshes intended for finite element fluid simulations which contain discrete element particles. The triangle edges are treated as springs which rela...In this research, we have improved a relaxation method for triangular meshes intended for finite element fluid simulations which contain discrete element particles. The triangle edges are treated as springs which relax their lengths towards a “better” force equilibrium where the triangles are closer to equilateral shape. The actual kernel is an improved zero order integrator which is able to follow reconfigurations of the particles faster than earlier methods. The improved relaxation allows larger timesteps in the flow simulation and leads to more stable, faster mesh reconfigurations for fast moving particles in the flow. Additionally, this demonstrates how integrators of the same order zero can nevertheless have different convergence speeds towards展开更多
With derivative spectrophotometric method,the complexes of lanthanides with 2-(5-bromo-2-pyridylazo)-5-diethylaminophen- ol(5-Br-PADAP)in the presence of octylphenol poly(ethyleneg- lycol)ether(TX-100)were studied.It ...With derivative spectrophotometric method,the complexes of lanthanides with 2-(5-bromo-2-pyridylazo)-5-diethylaminophen- ol(5-Br-PADAP)in the presence of octylphenol poly(ethyleneg- lycol)ether(TX-100)were studied.It is found that the maximum absorption of fourth-order derivative spectra of the neodymium complex by 4f electron transitions is at 579(+)nm and 582(-)nm with molar derivative absorptivities of 5.2×10~3 1.mol^(-1).cm^(-1). The maximum absorption of the zero-order derivative spectra of the complexes for neodymium and praseodymium is at 580hm,the molar absorptivities are 1.47×10~5 l.mol^(-1).cm^(-1)for Nd and 1.26 ×10~5 l.mol^(-1).cm^(-1)for Pr.The component ratio of the complex is Nd:5-Br-PADAP=1:4.Beer's law is obeyed in the range of 0-3.75μg of Nd and Pr in 25ml of solution.The method has been used for the simultaneous determination of Nd and Pr in four synthetic samples and the results obtained are satisfactory.展开更多
Holder’s inequality, its refinement, and reverse have received considerable attention in the theory of mathematical analysis and differential equations. In this paper, we give some refinements of Holder’s inequality...Holder’s inequality, its refinement, and reverse have received considerable attention in the theory of mathematical analysis and differential equations. In this paper, we give some refinements of Holder’s inequality and its reverse using a simple analytical technique of algebra and calculus. Our results show many results related to holder’s inequality as special cases of the inequalities presented.展开更多
The proliferation of digital payment methods facilitated by various online platforms and applications has led to a surge in financial fraud,particularly in credit card transactions.Advanced technologies such as machin...The proliferation of digital payment methods facilitated by various online platforms and applications has led to a surge in financial fraud,particularly in credit card transactions.Advanced technologies such as machine learning have been widely employed to enhance the early detection and prevention of losses arising frompotentially fraudulent activities.However,a prevalent approach in existing literature involves the use of extensive data sampling and feature selection algorithms as a precursor to subsequent investigations.While sampling techniques can significantly reduce computational time,the resulting dataset relies on generated data and the accuracy of the pre-processing machine learning models employed.Such datasets often lack true representativeness of realworld data,potentially introducing secondary issues that affect the precision of the results.For instance,undersampling may result in the loss of critical information,while over-sampling can lead to overfitting machine learning models.In this paper,we proposed a classification study of credit card fraud using fundamental machine learning models without the application of any sampling techniques on all the features present in the original dataset.The results indicate that Support Vector Machine(SVM)consistently achieves classification performance exceeding 90%across various evaluation metrics.This discovery serves as a valuable reference for future research,encouraging comparative studies on original dataset without the reliance on sampling techniques.Furthermore,we explore hybrid machine learning techniques,such as ensemble learning constructed based on SVM,K-Nearest Neighbor(KNN)and decision tree,highlighting their potential advancements in the field.The study demonstrates that the proposed machine learning models yield promising results,suggesting that pre-processing the dataset with sampling algorithm or additional machine learning technique may not always be necessary.This research contributes to the field of credit card fraud detection by emphasizing the potential of employing machine learning models directly on original datasets,thereby simplifying the workflow and potentially improving the accuracy and efficiency of fraud detection systems.展开更多
This paper investigates the effects of tool holder materials on chatter vibration in turning operations.The study uses a complex dynamic turning model with two degrees of freedom for the orthogonal cutting system.Tool...This paper investigates the effects of tool holder materials on chatter vibration in turning operations.The study uses a complex dynamic turning model with two degrees of freedom for the orthogonal cutting system.Tool holders made from different materials,including Al 5083,Al 6082,Al 7012,and a standard 4140 material,were subjected to chatter vibration to investigate their process damping capabilities.The study found that the standard tool holder 4140 allows for higher stable depths of cut and produces similar process damping values compared to the other tool holders.Finite element analyses(FEA)were performed to verify the experimental results,and the modal and FEA analyses produced very similar results.The study concludes that future research should investigate the effects of tool holders made from high alloy steel alloys on process damping.Overall,this paper provides important insights into the effects of tool hold-er materials on chatter vibration and process damping in turning operations,which can help in the design of more effi-cient and effective cutting systems.展开更多
A large aspect ratio vibration reducing tool holder based on passive damping vibration reduction technology is designed to solve the vibration problem that occurs in deep hole machining of vertical lathes.A dynamic mo...A large aspect ratio vibration reducing tool holder based on passive damping vibration reduction technology is designed to solve the vibration problem that occurs in deep hole machining of vertical lathes.A dynamic model of passive damping vibration reduction tool holder was established,and the optimal damping ratio,optimal frequency ratio,and maximum relative amplitude were derived.Modal analysis of the passive damping vibrationreduction tool holder was conducted using software.The results showed that the maximum response amplitude of the passive damping vibration reduction tool holder decreased significantly compared to the original one.展开更多
基金Integration Application Status and Problems Investigation of ICH Q8,Q9,Q10 across the Product Life Cycle(No.20210605).
文摘Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws.Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system.We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system,which includes building a sound pharmacovigilance organizational structure,establishing a series of operational system files and cultivating professional talents.MAHs of China should improve the structure of enterprise pharmacovigilance system.Besides,members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment.If MAHs possess a large variety and quantity of products,a Drug Safety Committee should be established to ensure the timely discovery of risks.In addition,MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant,effective and operatable files combing with the actual operation of pharmacovigilance system.Finally,MAHs should introduce and train pharmacovigilance talents,and hire pharmacovigilance experts as consultants to solve the problem of talent shortage.
基金The Natural Science Foundation of Jiangsu Province (No.BK2006102)the National Natural Science Foundation of China(No.10772086)
文摘For eliminating the zero-order image in digital holography, a new method using the differential of the hologram intensity instead of the hologram itself for numerical reconstruction is proposed. This method is based on digital image processing. By analyzing the spatial spectrum of the off-axis digital hologram, it theoretically proves that the zero-order image can be effectively eliminated by differential before reconstruction. Then, the detected hologram is processed in the program with differential and reconstruction. Both the theoretical analysis and digital reconstruction results show that it can effectively eliminate the large bright spot in the center of the reconstructed image caused by the zero-order image, improve the image quality significantly, and render a better contrast of the reconstructed image. This method is very simple and convenient due to no superfluous optical elements and requiring only one time record.
基金Project supported by the National Natural Science Foundation of China(Grant Nos.81527901,11604361,and 91630309)。
文摘Shell structures have increasingly widespread applications in biomedical ultrasound fields such as contrast agents and drug delivery,which requires the precise prediction of the acoustic radiation force under various circumstances to improve the system efficiency.The acoustic radiation force exerted by a zero-order quasi-Bessel-Gauss beam on an elastic spherical shell near an impedance boundary is theoretically and numerically studied in this study.By means of the finite series method and the image theory,a zero-order quasi-Bessel-Gauss beam is expanded in terms of spherical harmonic functions,and the exact solution of the acoustic radiation force is derived based on the acoustic scattering theory.The acoustic radiation force function,which represents the radiation force per unit energy density and per unit cross-sectional surface,is especially investigated.Some simulated results for a polymethyl methacrylate shell and an aluminum shell are provided to illustrate the behavior of acoustic radiation force in this case.The simulated results show the oscillatory property and the negative radiation force caused by the impedance boundary.An appropriate relative thickness of the shell can generate sharp peaks for a polymethyl methacrylate shell.Strong radiation force can be obtained at small half-cone angles and the beam waist only affects the results at high frequencies.Considering that the quasi-Bessel-Gauss beam possesses both the energy focusing property and the non-diffracting advantage,this study is expected to be useful in the development of acoustic tweezers,contrast agent micro-shells,and drug delivery applications.
文摘In this research, we have improved a relaxation method for triangular meshes intended for finite element fluid simulations which contain discrete element particles. The triangle edges are treated as springs which relax their lengths towards a “better” force equilibrium where the triangles are closer to equilateral shape. The actual kernel is an improved zero order integrator which is able to follow reconfigurations of the particles faster than earlier methods. The improved relaxation allows larger timesteps in the flow simulation and leads to more stable, faster mesh reconfigurations for fast moving particles in the flow. Additionally, this demonstrates how integrators of the same order zero can nevertheless have different convergence speeds towards
文摘With derivative spectrophotometric method,the complexes of lanthanides with 2-(5-bromo-2-pyridylazo)-5-diethylaminophen- ol(5-Br-PADAP)in the presence of octylphenol poly(ethyleneg- lycol)ether(TX-100)were studied.It is found that the maximum absorption of fourth-order derivative spectra of the neodymium complex by 4f electron transitions is at 579(+)nm and 582(-)nm with molar derivative absorptivities of 5.2×10~3 1.mol^(-1).cm^(-1). The maximum absorption of the zero-order derivative spectra of the complexes for neodymium and praseodymium is at 580hm,the molar absorptivities are 1.47×10~5 l.mol^(-1).cm^(-1)for Nd and 1.26 ×10~5 l.mol^(-1).cm^(-1)for Pr.The component ratio of the complex is Nd:5-Br-PADAP=1:4.Beer's law is obeyed in the range of 0-3.75μg of Nd and Pr in 25ml of solution.The method has been used for the simultaneous determination of Nd and Pr in four synthetic samples and the results obtained are satisfactory.
文摘Holder’s inequality, its refinement, and reverse have received considerable attention in the theory of mathematical analysis and differential equations. In this paper, we give some refinements of Holder’s inequality and its reverse using a simple analytical technique of algebra and calculus. Our results show many results related to holder’s inequality as special cases of the inequalities presented.
文摘The proliferation of digital payment methods facilitated by various online platforms and applications has led to a surge in financial fraud,particularly in credit card transactions.Advanced technologies such as machine learning have been widely employed to enhance the early detection and prevention of losses arising frompotentially fraudulent activities.However,a prevalent approach in existing literature involves the use of extensive data sampling and feature selection algorithms as a precursor to subsequent investigations.While sampling techniques can significantly reduce computational time,the resulting dataset relies on generated data and the accuracy of the pre-processing machine learning models employed.Such datasets often lack true representativeness of realworld data,potentially introducing secondary issues that affect the precision of the results.For instance,undersampling may result in the loss of critical information,while over-sampling can lead to overfitting machine learning models.In this paper,we proposed a classification study of credit card fraud using fundamental machine learning models without the application of any sampling techniques on all the features present in the original dataset.The results indicate that Support Vector Machine(SVM)consistently achieves classification performance exceeding 90%across various evaluation metrics.This discovery serves as a valuable reference for future research,encouraging comparative studies on original dataset without the reliance on sampling techniques.Furthermore,we explore hybrid machine learning techniques,such as ensemble learning constructed based on SVM,K-Nearest Neighbor(KNN)and decision tree,highlighting their potential advancements in the field.The study demonstrates that the proposed machine learning models yield promising results,suggesting that pre-processing the dataset with sampling algorithm or additional machine learning technique may not always be necessary.This research contributes to the field of credit card fraud detection by emphasizing the potential of employing machine learning models directly on original datasets,thereby simplifying the workflow and potentially improving the accuracy and efficiency of fraud detection systems.
基金This study was supported by the Scientific Research Coordination Unit of Pamukkale University under the project number 2011BSP020.
文摘This paper investigates the effects of tool holder materials on chatter vibration in turning operations.The study uses a complex dynamic turning model with two degrees of freedom for the orthogonal cutting system.Tool holders made from different materials,including Al 5083,Al 6082,Al 7012,and a standard 4140 material,were subjected to chatter vibration to investigate their process damping capabilities.The study found that the standard tool holder 4140 allows for higher stable depths of cut and produces similar process damping values compared to the other tool holders.Finite element analyses(FEA)were performed to verify the experimental results,and the modal and FEA analyses produced very similar results.The study concludes that future research should investigate the effects of tool holders made from high alloy steel alloys on process damping.Overall,this paper provides important insights into the effects of tool hold-er materials on chatter vibration and process damping in turning operations,which can help in the design of more effi-cient and effective cutting systems.
基金Science and Technology Research Project of Liaoning Provincial Department of Education:Research on the Application of Damping and Vibration Reduction Technology in Key Components of Machine Tools(JYTMS20230066)The Fund of Liaoning Provincial Natural Science and Technology Foundation Regional Joint(No.2021-YKLH-08).
文摘A large aspect ratio vibration reducing tool holder based on passive damping vibration reduction technology is designed to solve the vibration problem that occurs in deep hole machining of vertical lathes.A dynamic model of passive damping vibration reduction tool holder was established,and the optimal damping ratio,optimal frequency ratio,and maximum relative amplitude were derived.Modal analysis of the passive damping vibrationreduction tool holder was conducted using software.The results showed that the maximum response amplitude of the passive damping vibration reduction tool holder decreased significantly compared to the original one.