In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding ...In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.展开更多
A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding ...A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding of multiple parts on a single machine in automobile factories. The system incorporates an automatic recognition system for different workpiece materials using the added machine fixture,visual detection system for nuts and bolts,and secondary graphical confirmation to ensure the correctness of specification calling. This system achieves reliable,fully automatic selection of welding specifications in resistance welding equipment and has shown significant effects in improving welding quality for massproduced workpieces,while solving the problem of specification calling errors that can occur with traditional methods involving process charts and code adjustments. This system is particularly suitable for promoting applications in manual welding of multiple parts on a single machine in automobile factories,ensuring correct specification calling and welding quality.展开更多
Big data on product sales are an emerging resource for supporting modular product design to meet diversified customers’requirements of product specification combinations.To better facilitate decision-making of modula...Big data on product sales are an emerging resource for supporting modular product design to meet diversified customers’requirements of product specification combinations.To better facilitate decision-making of modular product design,correlations among specifications and components originated from customers’conscious and subconscious preferences can be investigated by using big data on product sales.This study proposes a framework and the associated methods for supporting modular product design decisions based on correlation analysis of product specifications and components using big sales data.The correlations of the product specifications are determined by analyzing the collected product sales data.By building the relations between the product components and specifications,a matrix for measuring the correlation among product components is formed for component clustering.Six rules for supporting the decision making of modular product design are proposed based on the frequency analysis of the specification values per component cluster.A case study of electric vehicles illustrates the application of the proposed method.展开更多
Straightness error is an important parameter in measuring high-precision shafts. New generation geometrical product speeifieation(GPS) requires the measurement uncertainty characterizing the reliability of the resul...Straightness error is an important parameter in measuring high-precision shafts. New generation geometrical product speeifieation(GPS) requires the measurement uncertainty characterizing the reliability of the results should be given together when the measurement result is given. Nowadays most researches on straightness focus on error calculation and only several research projects evaluate the measurement uncertainty based on "The Guide to the Expression of Uncertainty in Measurement(GUM)". In order to compute spatial straightness error(SSE) accurately and rapidly and overcome the limitations of GUM, a quasi particle swarm optimization(QPSO) is proposed to solve the minimum zone SSE and Monte Carlo Method(MCM) is developed to estimate the measurement uncertainty. The mathematical model of minimum zone SSE is formulated. In QPSO quasi-random sequences are applied to the generation of the initial position and velocity of particles and their velocities are modified by the constriction factor approach. The flow of measurement uncertainty evaluation based on MCM is proposed, where the heart is repeatedly sampling from the probability density function(PDF) for every input quantity and evaluating the model in each case. The minimum zone SSE of a shaft measured on a Coordinate Measuring Machine(CMM) is calculated by QPSO and the measurement uncertainty is evaluated by MCM on the basis of analyzing the uncertainty contributors. The results show that the uncertainty directly influences the product judgment result. Therefore it is scientific and reasonable to consider the influence of the uncertainty in judging whether the parts are accepted or rejected, especially for those located in the uncertainty zone. The proposed method is especially suitable when the PDF of the measurand cannot adequately be approximated by a Gaussian distribution or a scaled and shifted t-distribution and the measurement model is non-linear.展开更多
We prove that a Cl-generic volume-preserving dynamical system (diffeomor- phism or flow) has the shadowing property or is expansive or has the weak specification property if and only if it is Anosov. Finally, as in ...We prove that a Cl-generic volume-preserving dynamical system (diffeomor- phism or flow) has the shadowing property or is expansive or has the weak specification property if and only if it is Anosov. Finally, as in [10, 27], we prove that the Cl-robustness, within the volume-preserving context, of the expansiveness property and the weak specifica- tion property, imply that the dynamical system (diffeomorphism or flow) is Anosov.展开更多
In ordet to maintain the dependability of system and meet the functional needof users dtsire, this paper introduces a survivability mechanism into embedded real-time system,and proposes a general comprehensive, approa...In ordet to maintain the dependability of system and meet the functional needof users dtsire, this paper introduces a survivability mechanism into embedded real-time system,and proposes a general comprehensive, approach based on a rigorous definition of survivability. Thisapproach permits a trade-off between the function and the cost of system development. It emphasizesthe ultradependable implementation of crucial function without demanding that of entire system.展开更多
SUMMARY The p value has been widely used as a way to summarise the significance in data analysis. However, misuse and misinterpretation of the p value is common in practice. Our result shows that if the model specific...SUMMARY The p value has been widely used as a way to summarise the significance in data analysis. However, misuse and misinterpretation of the p value is common in practice. Our result shows that if the model specification is wrong, the distribution of the p value may be inappropriate, which makes the decision based on the p value invalid.展开更多
IntroductionThe PXI industry standard has quickly gained adoption and grown in prevalence in automated test systems since its release in 1998. PXI is being selected as the platform of choice for thousands of applicati...IntroductionThe PXI industry standard has quickly gained adoption and grown in prevalence in automated test systems since its release in 1998. PXI is being selected as the platform of choice for thousands of applications, from areas such as military and aerospace, consumer electronics, and communications, to process control and industrial automation. One of the key elements driving the rapid adoption of PXI is its use of PCI in the communication backplane. Now, as the commercial PC industry drastically improves the available bus bandwidth by evolving PCI to PCI Express, PXI has the ability to meet even more application needs by integrating PCI Express into the PXI standard.展开更多
Steviol glycosides are natural sweetener constituents found in the leaves of Stevia rebaudiana Bertoni (Asteraceae). The specifications for steviol glycosides were established by the Joint FAO/WHO Expert Committee on ...Steviol glycosides are natural sweetener constituents found in the leaves of Stevia rebaudiana Bertoni (Asteraceae). The specifications for steviol glycosides were established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2008, although there was a call in the following year for the modification of this assay method to enable the determination of nine steviol glycosides rather than just seven. In response, based on a proposed method by the Japan Stevia Association, we developed an improved method by changing the HPLC conditions and including the use of an octadecylsilyl column instead of an amino-bonded column to enable the rapid and reliable determination of the nine steviol glycosides by an isocratic HPLC-UV method. With the developed method, the nine steviol glycosides can be separately determined, and identified using individual reference chemicals as standards, unlike the previous identification method, which was based on the relative retention times. In addition, the single stevioside quantification standard was replaced with both stevioside and rebaudioside A quantification standards. Importantly, the validation of the developed method was successful. The limits of quantification for the nine steviol glycosides were between 0.2% and 0.6%. The developed assay method for the nine steviol glycosides was proposed to JECFA and adopted as the revised assay method for the steviol glycosides specifications at its 73rd meeting in 2010.展开更多
Many blinding diseases,such as retinitis pigmentosa,age-related macular degeneration,and glaucoma involve the permanent loss of retinal neurons,especially photoreceptors or the centrally projecting retinal ganglion ce...Many blinding diseases,such as retinitis pigmentosa,age-related macular degeneration,and glaucoma involve the permanent loss of retinal neurons,especially photoreceptors or the centrally projecting retinal ganglion cells.Stem cells have been proposed as a potential source of cells for neuronal transplantation.展开更多
Introduction The success in lineage-specific differentiation of human embryonic and induced pluripotent stem(hES/iPS)cells raises new hopes for cell-based therapies.It is envisioned that cells differentiated from hES/...Introduction The success in lineage-specific differentiation of human embryonic and induced pluripotent stem(hES/iPS)cells raises new hopes for cell-based therapies.It is envisioned that cells differentiated from hES/iPS cells can be used to replace or repair damaged or diseased cells and tissues in body.This has not yet been possible due to the difficulty in generating biologically functional cells in vitro.While many factors may contribute to these failures,the lack of tissue niches in the current differentiation systems has been viewed in impairing the maturation of these cells.As revealed by studying mice embryo development,organ development requires strict temporal and spatial control at each stage.The stepwise hESC differentiation展开更多
基金supported by the Grant for Development of New Faculty Staff,Ratchadaphiseksomphot Endowment Fund,Chula-longkorn University,Thailand(Grant No.:DNS64_047_33_003_1 to Patanachai K.Limpikirati)Grant for Development of New Scholar,Office of the Permanent Secretary,Ministry of Higher Ed-ucation,Science,Research and Innovation,Thailand(Grant No.:RGNS64_012 to Patanachai K.Limpikirati).
文摘In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.
文摘A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding of multiple parts on a single machine in automobile factories. The system incorporates an automatic recognition system for different workpiece materials using the added machine fixture,visual detection system for nuts and bolts,and secondary graphical confirmation to ensure the correctness of specification calling. This system achieves reliable,fully automatic selection of welding specifications in resistance welding equipment and has shown significant effects in improving welding quality for massproduced workpieces,while solving the problem of specification calling errors that can occur with traditional methods involving process charts and code adjustments. This system is particularly suitable for promoting applications in manual welding of multiple parts on a single machine in automobile factories,ensuring correct specification calling and welding quality.
基金National Key R&D Program of China(Grant No.2018YFB1701701)Sailing Talent Program+1 种基金Guangdong Provincial Science and Technologies Program of China(Grant No.2017B090922008)Special Grand Grant from Tianjin City Government of China。
文摘Big data on product sales are an emerging resource for supporting modular product design to meet diversified customers’requirements of product specification combinations.To better facilitate decision-making of modular product design,correlations among specifications and components originated from customers’conscious and subconscious preferences can be investigated by using big data on product sales.This study proposes a framework and the associated methods for supporting modular product design decisions based on correlation analysis of product specifications and components using big sales data.The correlations of the product specifications are determined by analyzing the collected product sales data.By building the relations between the product components and specifications,a matrix for measuring the correlation among product components is formed for component clustering.Six rules for supporting the decision making of modular product design are proposed based on the frequency analysis of the specification values per component cluster.A case study of electric vehicles illustrates the application of the proposed method.
基金supported by National Natural Science Foundation of China (Grant No. 51075198)Jiangsu Provincial Natural Science Foundation of China (Grant No. BK2010479)+2 种基金Innovation Research of Nanjing Institute of Technology, China (Grant No. CKJ20100008)Jiangsu Provincial Foundation of 333 Talents Engineering of ChinaJiangsu Provincial Foundation of Six Talented Peak of China
文摘Straightness error is an important parameter in measuring high-precision shafts. New generation geometrical product speeifieation(GPS) requires the measurement uncertainty characterizing the reliability of the results should be given together when the measurement result is given. Nowadays most researches on straightness focus on error calculation and only several research projects evaluate the measurement uncertainty based on "The Guide to the Expression of Uncertainty in Measurement(GUM)". In order to compute spatial straightness error(SSE) accurately and rapidly and overcome the limitations of GUM, a quasi particle swarm optimization(QPSO) is proposed to solve the minimum zone SSE and Monte Carlo Method(MCM) is developed to estimate the measurement uncertainty. The mathematical model of minimum zone SSE is formulated. In QPSO quasi-random sequences are applied to the generation of the initial position and velocity of particles and their velocities are modified by the constriction factor approach. The flow of measurement uncertainty evaluation based on MCM is proposed, where the heart is repeatedly sampling from the probability density function(PDF) for every input quantity and evaluating the model in each case. The minimum zone SSE of a shaft measured on a Coordinate Measuring Machine(CMM) is calculated by QPSO and the measurement uncertainty is evaluated by MCM on the basis of analyzing the uncertainty contributors. The results show that the uncertainty directly influences the product judgment result. Therefore it is scientific and reasonable to consider the influence of the uncertainty in judging whether the parts are accepted or rejected, especially for those located in the uncertainty zone. The proposed method is especially suitable when the PDF of the measurand cannot adequately be approximated by a Gaussian distribution or a scaled and shifted t-distribution and the measurement model is non-linear.
基金partially supported by National Funds through FCT-"Fundacao para a Ciencia e a Tecnologia",(PEst-OE/MAT/UI0212/2011)supported by Basic Science Research Program through the National Research Foundation of Korea(NRF)funded by the Ministry,ICT&Future Planning(No.2014R1A1A1A05002124)supported by National Natural Science Foundation of China(No.11301018 and 11371046)
文摘We prove that a Cl-generic volume-preserving dynamical system (diffeomor- phism or flow) has the shadowing property or is expansive or has the weak specification property if and only if it is Anosov. Finally, as in [10, 27], we prove that the Cl-robustness, within the volume-preserving context, of the expansiveness property and the weak specifica- tion property, imply that the dynamical system (diffeomorphism or flow) is Anosov.
文摘In ordet to maintain the dependability of system and meet the functional needof users dtsire, this paper introduces a survivability mechanism into embedded real-time system,and proposes a general comprehensive, approach based on a rigorous definition of survivability. Thisapproach permits a trade-off between the function and the cost of system development. It emphasizesthe ultradependable implementation of crucial function without demanding that of entire system.
文摘SUMMARY The p value has been widely used as a way to summarise the significance in data analysis. However, misuse and misinterpretation of the p value is common in practice. Our result shows that if the model specification is wrong, the distribution of the p value may be inappropriate, which makes the decision based on the p value invalid.
文摘IntroductionThe PXI industry standard has quickly gained adoption and grown in prevalence in automated test systems since its release in 1998. PXI is being selected as the platform of choice for thousands of applications, from areas such as military and aerospace, consumer electronics, and communications, to process control and industrial automation. One of the key elements driving the rapid adoption of PXI is its use of PCI in the communication backplane. Now, as the commercial PC industry drastically improves the available bus bandwidth by evolving PCI to PCI Express, PXI has the ability to meet even more application needs by integrating PCI Express into the PXI standard.
文摘Steviol glycosides are natural sweetener constituents found in the leaves of Stevia rebaudiana Bertoni (Asteraceae). The specifications for steviol glycosides were established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2008, although there was a call in the following year for the modification of this assay method to enable the determination of nine steviol glycosides rather than just seven. In response, based on a proposed method by the Japan Stevia Association, we developed an improved method by changing the HPLC conditions and including the use of an octadecylsilyl column instead of an amino-bonded column to enable the rapid and reliable determination of the nine steviol glycosides by an isocratic HPLC-UV method. With the developed method, the nine steviol glycosides can be separately determined, and identified using individual reference chemicals as standards, unlike the previous identification method, which was based on the relative retention times. In addition, the single stevioside quantification standard was replaced with both stevioside and rebaudioside A quantification standards. Importantly, the validation of the developed method was successful. The limits of quantification for the nine steviol glycosides were between 0.2% and 0.6%. The developed assay method for the nine steviol glycosides was proposed to JECFA and adopted as the revised assay method for the steviol glycosides specifications at its 73rd meeting in 2010.
基金supported by grants from the Spanish Ministerio de Cienciay Tecnología(BFU2007-67540)the Junta de Extremadura(PRI06A195,GR10152)
文摘Many blinding diseases,such as retinitis pigmentosa,age-related macular degeneration,and glaucoma involve the permanent loss of retinal neurons,especially photoreceptors or the centrally projecting retinal ganglion cells.Stem cells have been proposed as a potential source of cells for neuronal transplantation.
文摘Introduction The success in lineage-specific differentiation of human embryonic and induced pluripotent stem(hES/iPS)cells raises new hopes for cell-based therapies.It is envisioned that cells differentiated from hES/iPS cells can be used to replace or repair damaged or diseased cells and tissues in body.This has not yet been possible due to the difficulty in generating biologically functional cells in vitro.While many factors may contribute to these failures,the lack of tissue niches in the current differentiation systems has been viewed in impairing the maturation of these cells.As revealed by studying mice embryo development,organ development requires strict temporal and spatial control at each stage.The stepwise hESC differentiation