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
Chinese medicated bath is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The“International Standard of Traditional Chinese Medicine Techniques:The Operating S...Chinese medicated bath is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The“International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicated Bath”is drawn up by the Beijing University of Chinese Medicine Third Affiliated Hospital and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.展开更多
s: The farmland shelterbelts in Northeastern Plain of China have formed relatively complete net system. The func-tions of shelterbelt net in omnibearing wind check and prevention of frostbite as well as the field of ...s: The farmland shelterbelts in Northeastern Plain of China have formed relatively complete net system. The func-tions of shelterbelt net in omnibearing wind check and prevention of frostbite as well as the field of integrated climate effect within shelterbelt net were analyzed, through located observation of meteorological factors. Within the shelterbelt net, the area with more than 10% efficiency of omnibearing wind check was determined as benefited area. The analysis of yield and quality of crops indicated that the sheltering range of shelterbelt net was 25 times tree height. The mature heights of the various varieties of poplar composed the shelterbelts were determined according to their height growth. Based on the comprehensive analysis above, the suitable size of farmland shelterbelt net in Northeastern Plain of China was decided to be 400 m×400 m.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
The Chinese standard Q/SHR001-95 for base stocks is compared with the APIspecifications. The viscosity-temperature characteristics of base stock required by lube oil in useand market demand on oil quality are analyzed...The Chinese standard Q/SHR001-95 for base stocks is compared with the APIspecifications. The viscosity-temperature characteristics of base stock required by lube oil in useand market demand on oil quality are analyzed. The quality indicators of base stocks in China andother countries are compared. A new classification of base stocks in response to the requirements ofmodern lube oil is proposed and the research on new technology to produce premium base stocksmeeting API specification is recommended on the basis of current base stock processing technology.展开更多
This paper elaborates on the seedling technology,field cultivation technology,field management technology,seed harvesting and seed processing technology in the propagation process of Gentiana macrophylla to provide te...This paper elaborates on the seedling technology,field cultivation technology,field management technology,seed harvesting and seed processing technology in the propagation process of Gentiana macrophylla to provide technical support for artificial breeding of G. macrophylla.展开更多
Bioremediation of shorelines polluted by spilling oil has no secondary pollution and saves manpower and material resources, so it has a wide market. Standardizing the operation methods and materials used of the techno...Bioremediation of shorelines polluted by spilling oil has no secondary pollution and saves manpower and material resources, so it has a wide market. Standardizing the operation methods and materials used of the technology can improve its efficiency. Therefore, the research process of technical specifications for bioremediation of shorelines polluted by spilling oil at home and abroad was expounded in this study.展开更多
The objective of this research is to investigate the impact of infestation by the confused flour beetle Tribolium confusum on the specification of flour and its product. The results of this work showed that infestatio...The objective of this research is to investigate the impact of infestation by the confused flour beetle Tribolium confusum on the specification of flour and its product. The results of this work showed that infestation by the confused flour beetle with 5 pairs of adult stage and its progeny within 3 months period may cause high deterioration and damaged of the flour specification. The people in lraq get their flour from some official and non-official mills which they produce not so good quality of this flour in addition to which it contains some times an infestation with the two species of the flour beetles T. castaneum and T. confusum, when people do not use this quantity as quickly as possible during this period of storage, the beetles will be increased in numbers and make the flour unacceptable for any kind of pastes or bread. The infestation by this beetle causes great pollution to the flour by the ecdysial of larvae and a bad smell that it leaves on the flour and all its products.展开更多
The application of a closed-loop specification oriented feedback control design method, which addresses the design of controllers to satisfy multiple simultaneous conflicting closed-loop performance specifications is ...The application of a closed-loop specification oriented feedback control design method, which addresses the design of controllers to satisfy multiple simultaneous conflicting closed-loop performance specifications is presented. The proposed approach is well suited to the design of controllers which must meet a set of conflicting performance specifications. Gain tuning is central to the design process, however, the tuning process is greatly simplified over that presented by the problem of tuning a PID controller for example. The proposed control method is applied to an AC induction motor, with an inner-loop flux vector controller applied to design a position control system. Experimental results verify the effectiveness of this method.展开更多
The application of work strategies taking into account, from the initial stages, all the factors involved in the product design process is considered essential by the researches to generate higher quality products, as...The application of work strategies taking into account, from the initial stages, all the factors involved in the product design process is considered essential by the researches to generate higher quality products, assess users’ needs and anticipate design problems. This paper presents two approaches of design project development, denominated respectively: projects with imposed specifications and projects with derived specifications and proposes the use of the matrix that integrates specifications and design factors (SFM). This design support tool complements others already used in the development of product concepts by higher education students, increasing the capacity of synthesis and structuring of information in order to facilitate decision-making into the design process. Its elaboration implies understanding of objectives, identifying of factors and establishing of specifications. At the same time, it aims to foster the reflection process and an integrated information analysis. The application of SFM and its contribution to different project approaches are shown in this paper.展开更多
The ablation parameters such as threshold fluence, etch depth, ablation rate and the effect of material targets were investigated under the interaction of laser pulse with low intensity. The parameters of the laser sy...The ablation parameters such as threshold fluence, etch depth, ablation rate and the effect of material targets were investigated under the interaction of laser pulse with low intensity. The parameters of the laser system are： laser pulse energy in the range of 110–140 m J, wavelength1064 nm and pulse duration 20 ns. By macroscopic estimation of the outward images of the ablation and data obtained, we can conclude that the photothermal and photoionization processes have more influence for aluminum ablation. In contrast, for polymer samples, from the macroscopic observation of the border pattern at the irradiated spot, and also the data obtained from the experiment results, we deduce that both chemical change due to heating and photochemical dissociation were effective mechanisms of ablation. However, concerning the two polymer samples, apart from considering the same theoretical ablation model, it is conceived that the photomehanical specifications of PMMA are involved in the ablation parameters. The threshold fluence for an ablation rate of 30 laser shots were obtained as 12.4, 24.64, and 11.71 J cm^（-2）, for aluminum, silicon rubber and polymethylmethacrylate（PMMA） respectively.The ablation rate is exponentially decreased by the laser-shot number, especially for aluminum.Furthermore, the etch depth after 30 laser shots was measured as 180, 630 and 870 μm, for aluminum, silicon rubber and PMMA, respectively.展开更多
General Administration of Quality Supervision,Inspection and Quarantine of P.R.China has approved the following 8 national measuring verification regulations in 2010 and publicize now.
This paper is concerned with the control synthesis problem via dynamic output feedback for linear continuous-time systems with mixed frequency small gain specifications.A new method for designing dynamic output feedba...This paper is concerned with the control synthesis problem via dynamic output feedback for linear continuous-time systems with mixed frequency small gain specifications.A new method for designing dynamic output feedback controllers is presented such that the resulting closed-loop systems are asymptotically stable and meet the requirements of small gain specifications in both finite frequency ranges and the entire frequency range.The design conditions are given in terms of solutions to a set of linear matrix inequalities(LMIs).Finally,a numerical example is given to illustrate the design procedure and the advantage of the proposed method in comparison with the existing one.展开更多
General Administration of Quality Supervision,Inspection and Quarantine of P.R.China has approved the following 11 national measuring verification regulations in 2008 and publicize now.
General Administration of Quality Supervision,Inspection and Quarantine of P.R.China hasapproved the following 24 national measuring verification regulations in 2008 and publicize now.
General Administration of Quality Supervision,Inspection and Quarantine of P.R.China has approved the following 10 national measuring verification regulations in 2008 and publicize now.
Based on SCR(Software Cost Reduction), this paper presents a formal mOdel analyzingSCR-style requirements- This model mainly apply state trans1ation rules, semantic computing rules and attributes to define formal seme...Based on SCR(Software Cost Reduction), this paper presents a formal mOdel analyzingSCR-style requirements- This model mainly apply state trans1ation rules, semantic computing rules and attributes to define formal sementics of a tabular notation in the SCR requirements method, and may automatically analyze requirements specifications to be specified by the SCR method. Combining with a simp1eexample, this paper introduces how to analyze consistency and completeness of requirements specifica-tlons.展开更多
The quality of mischmetal wire and rod and the method of adding rare earth into steel are quite important for making high quality steel. This paper proposes a quality specification of wire and rod as well as related a...The quality of mischmetal wire and rod and the method of adding rare earth into steel are quite important for making high quality steel. This paper proposes a quality specification of wire and rod as well as related adding method. The paper also provides principles for selecting raw material and adding method.展开更多
Main design parameters of MCC （metallic card clothing） which include front angle, base width, tooth pitch, and tooth point dimensions are discussed to investigate the carding effect of MCC. Experimental results show...Main design parameters of MCC （metallic card clothing） which include front angle, base width, tooth pitch, and tooth point dimensions are discussed to investigate the carding effect of MCC. Experimental results show that type C machine has the best carding effect, which is not ascribed to single factor control but the integrated design optimization and good performance of wire teeth. In comparison with the teeth design, the wire performance is another important factor that influences the perfommnce of modem high efficient production carding machine.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.
基金National Key R&D Plan:Development of International Standards for Traditional Chinese Medicine Technology(No.2019YFC1712003)。
文摘Chinese medicated bath is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The“International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicated Bath”is drawn up by the Beijing University of Chinese Medicine Third Affiliated Hospital and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.
文摘s: The farmland shelterbelts in Northeastern Plain of China have formed relatively complete net system. The func-tions of shelterbelt net in omnibearing wind check and prevention of frostbite as well as the field of integrated climate effect within shelterbelt net were analyzed, through located observation of meteorological factors. Within the shelterbelt net, the area with more than 10% efficiency of omnibearing wind check was determined as benefited area. The analysis of yield and quality of crops indicated that the sheltering range of shelterbelt net was 25 times tree height. The mature heights of the various varieties of poplar composed the shelterbelts were determined according to their height growth. Based on the comprehensive analysis above, the suitable size of farmland shelterbelt net in Northeastern Plain of China was decided to be 400 m×400 m.
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.
文摘The Chinese standard Q/SHR001-95 for base stocks is compared with the APIspecifications. The viscosity-temperature characteristics of base stock required by lube oil in useand market demand on oil quality are analyzed. The quality indicators of base stocks in China andother countries are compared. A new classification of base stocks in response to the requirements ofmodern lube oil is proposed and the research on new technology to produce premium base stocksmeeting API specification is recommended on the basis of current base stock processing technology.
基金Supported by Lanzhou Talent Innovation and Entrepreneurship Project(2016-RC-64)Agricultural Science and Technology Innovation Team Project of Gansu Academy of Agricultural Sciences(2017GAAS29)
文摘This paper elaborates on the seedling technology,field cultivation technology,field management technology,seed harvesting and seed processing technology in the propagation process of Gentiana macrophylla to provide technical support for artificial breeding of G. macrophylla.
文摘Bioremediation of shorelines polluted by spilling oil has no secondary pollution and saves manpower and material resources, so it has a wide market. Standardizing the operation methods and materials used of the technology can improve its efficiency. Therefore, the research process of technical specifications for bioremediation of shorelines polluted by spilling oil at home and abroad was expounded in this study.
文摘The objective of this research is to investigate the impact of infestation by the confused flour beetle Tribolium confusum on the specification of flour and its product. The results of this work showed that infestation by the confused flour beetle with 5 pairs of adult stage and its progeny within 3 months period may cause high deterioration and damaged of the flour specification. The people in lraq get their flour from some official and non-official mills which they produce not so good quality of this flour in addition to which it contains some times an infestation with the two species of the flour beetles T. castaneum and T. confusum, when people do not use this quantity as quickly as possible during this period of storage, the beetles will be increased in numbers and make the flour unacceptable for any kind of pastes or bread. The infestation by this beetle causes great pollution to the flour by the ecdysial of larvae and a bad smell that it leaves on the flour and all its products.
文摘The application of a closed-loop specification oriented feedback control design method, which addresses the design of controllers to satisfy multiple simultaneous conflicting closed-loop performance specifications is presented. The proposed approach is well suited to the design of controllers which must meet a set of conflicting performance specifications. Gain tuning is central to the design process, however, the tuning process is greatly simplified over that presented by the problem of tuning a PID controller for example. The proposed control method is applied to an AC induction motor, with an inner-loop flux vector controller applied to design a position control system. Experimental results verify the effectiveness of this method.
文摘The application of work strategies taking into account, from the initial stages, all the factors involved in the product design process is considered essential by the researches to generate higher quality products, assess users’ needs and anticipate design problems. This paper presents two approaches of design project development, denominated respectively: projects with imposed specifications and projects with derived specifications and proposes the use of the matrix that integrates specifications and design factors (SFM). This design support tool complements others already used in the development of product concepts by higher education students, increasing the capacity of synthesis and structuring of information in order to facilitate decision-making into the design process. Its elaboration implies understanding of objectives, identifying of factors and establishing of specifications. At the same time, it aims to foster the reflection process and an integrated information analysis. The application of SFM and its contribution to different project approaches are shown in this paper.
文摘The ablation parameters such as threshold fluence, etch depth, ablation rate and the effect of material targets were investigated under the interaction of laser pulse with low intensity. The parameters of the laser system are： laser pulse energy in the range of 110–140 m J, wavelength1064 nm and pulse duration 20 ns. By macroscopic estimation of the outward images of the ablation and data obtained, we can conclude that the photothermal and photoionization processes have more influence for aluminum ablation. In contrast, for polymer samples, from the macroscopic observation of the border pattern at the irradiated spot, and also the data obtained from the experiment results, we deduce that both chemical change due to heating and photochemical dissociation were effective mechanisms of ablation. However, concerning the two polymer samples, apart from considering the same theoretical ablation model, it is conceived that the photomehanical specifications of PMMA are involved in the ablation parameters. The threshold fluence for an ablation rate of 30 laser shots were obtained as 12.4, 24.64, and 11.71 J cm^（-2）, for aluminum, silicon rubber and polymethylmethacrylate（PMMA） respectively.The ablation rate is exponentially decreased by the laser-shot number, especially for aluminum.Furthermore, the etch depth after 30 laser shots was measured as 180, 630 and 870 μm, for aluminum, silicon rubber and PMMA, respectively.
文摘General Administration of Quality Supervision,Inspection and Quarantine of P.R.China has approved the following 8 national measuring verification regulations in 2010 and publicize now.
基金Supported by Program for New Century Excellent Talents in University(NCET-04-0283)the Funds for Creative Research Groups of China(60521003)+4 种基金Program for Changjiang Scholars and Innovative Research Team in University(IRT0421)the State Key Program of National Natural Science Foundation of China(60534010)and National Natural Science Foundation of China(60674021)the Funds of Ph.D.Program of Ministry of Education,China(20060145019)the 111 Project(B08015)
文摘This paper is concerned with the control synthesis problem via dynamic output feedback for linear continuous-time systems with mixed frequency small gain specifications.A new method for designing dynamic output feedback controllers is presented such that the resulting closed-loop systems are asymptotically stable and meet the requirements of small gain specifications in both finite frequency ranges and the entire frequency range.The design conditions are given in terms of solutions to a set of linear matrix inequalities(LMIs).Finally,a numerical example is given to illustrate the design procedure and the advantage of the proposed method in comparison with the existing one.
文摘General Administration of Quality Supervision,Inspection and Quarantine of P.R.China has approved the following 11 national measuring verification regulations in 2008 and publicize now.
文摘General Administration of Quality Supervision,Inspection and Quarantine of P.R.China hasapproved the following 24 national measuring verification regulations in 2008 and publicize now.
文摘General Administration of Quality Supervision,Inspection and Quarantine of P.R.China has approved the following 10 national measuring verification regulations in 2008 and publicize now.
文摘Based on SCR(Software Cost Reduction), this paper presents a formal mOdel analyzingSCR-style requirements- This model mainly apply state trans1ation rules, semantic computing rules and attributes to define formal sementics of a tabular notation in the SCR requirements method, and may automatically analyze requirements specifications to be specified by the SCR method. Combining with a simp1eexample, this paper introduces how to analyze consistency and completeness of requirements specifica-tlons.
文摘The quality of mischmetal wire and rod and the method of adding rare earth into steel are quite important for making high quality steel. This paper proposes a quality specification of wire and rod as well as related adding method. The paper also provides principles for selecting raw material and adding method.
文摘Main design parameters of MCC （metallic card clothing） which include front angle, base width, tooth pitch, and tooth point dimensions are discussed to investigate the carding effect of MCC. Experimental results show that type C machine has the best carding effect, which is not ascribed to single factor control but the integrated design optimization and good performance of wire teeth. In comparison with the teeth design, the wire performance is another important factor that influences the perfommnce of modem high efficient production carding machine.
