The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not...The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.展开更多
Journal overview:Journal of Mathematical Research with, Applications (JMRA), formerly Journal of Mathematical Research and Exposition (JMRE) created in 1981, one of the transactions of China Society for Industrial and...Journal overview:Journal of Mathematical Research with, Applications (JMRA), formerly Journal of Mathematical Research and Exposition (JMRE) created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises:pure and applied mathematicians, graduate students in broad fields of sciences and technology,scientists and engineers interested in mathematics.Publishing cycle:JMRA is currently published bimonthly with 112 pages for this issue.Indexing:JMRA, as the successor of JMRE.展开更多
Journal overview: Journal of Mathematical Research with Applications (JMRA), formerly Journal of Mathematical Research and Exposition (JM RE) created in 1981, one of the transactions of China Society for Industrial an...Journal overview: Journal of Mathematical Research with Applications (JMRA), formerly Journal of Mathematical Research and Exposition (JM RE) created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises: pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industria...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Ad...It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.展开更多
Recent estimates indicate that more than half the software market belongs to enterprise applications. One of the greatest challenges in these is in conducting the complex process of adaptation of pre-packaged applicat...Recent estimates indicate that more than half the software market belongs to enterprise applications. One of the greatest challenges in these is in conducting the complex process of adaptation of pre-packaged applications, such as Oracle or SAP, to the organization needs. Although very detailed, structured and well documented methods govern this process, the consulting team implementing the method must spend much manual effort in making sure that the guidelines of the method are followed as intended by the method author. The problem is exacerbated by the diversity of skills and roles of team members, and the many sorts of communications of collaboration that methods prescribe. By enhancing the metamodel in which the methods are defined, we automatically produce a CASE tool (so to speak) for the applications of these methods. Our results are successfully employed in a number of large, ongoing projects with demonstrable, non-meager saving.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industria...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics展开更多
In this research we are going to define two new concepts: a) “The Potential of Events” (EP) and b) “The Catholic Information” (CI). The term CI derives from the ancient Greek language and declares all the Catholic...In this research we are going to define two new concepts: a) “The Potential of Events” (EP) and b) “The Catholic Information” (CI). The term CI derives from the ancient Greek language and declares all the Catholic (general) Logical Propositions (<img src="Edit_5f13a4a5-abc6-4bc5-9e4c-4ff981627b2a.png" width="33" height="21" alt="" />) which will true for every element of a set A. We will study the Riemann Hypothesis in two stages: a) By using the EP we will prove that the distribution of events e (even) and o (odd) of Square Free Numbers (SFN) on the axis Ax(N) of naturals is Heads-Tails (H-T) type. b) By using the CI we will explain the way that the distribution of prime numbers can be correlated with the non-trivial zeros of the function ζ(s) of Riemann. The Introduction and the Chapter 2 are necessary for understanding the solution. In the Chapter 3 we will present a simple method of forecasting in many very useful applications (e.g. financial, technological, medical, social, etc) developing a generalization of this new, proven here, theory which we finally apply to the solution of RH. The following Introduction as well the Results with the Discussion at the end shed light about the possibility of the proof of all the above. The article consists of 9 chapters that are numbered by 1, 2, …, 9.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, is a home for original research papers of the highest ...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, is a home for original research papers of the highest quality in ,all areas of pure and applied mathematics. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industria...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the Transactions of China Society for Industria...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the Transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industria...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the Transactions of China Society for Industria...Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the Transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.展开更多
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.
文摘Journal overview:Journal of Mathematical Research with, Applications (JMRA), formerly Journal of Mathematical Research and Exposition (JMRE) created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises:pure and applied mathematicians, graduate students in broad fields of sciences and technology,scientists and engineers interested in mathematics.Publishing cycle:JMRA is currently published bimonthly with 112 pages for this issue.Indexing:JMRA, as the successor of JMRE.
文摘Journal overview: Journal of Mathematical Research with Applications (JMRA), formerly Journal of Mathematical Research and Exposition (JM RE) created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises: pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.
文摘Recent estimates indicate that more than half the software market belongs to enterprise applications. One of the greatest challenges in these is in conducting the complex process of adaptation of pre-packaged applications, such as Oracle or SAP, to the organization needs. Although very detailed, structured and well documented methods govern this process, the consulting team implementing the method must spend much manual effort in making sure that the guidelines of the method are followed as intended by the method author. The problem is exacerbated by the diversity of skills and roles of team members, and the many sorts of communications of collaboration that methods prescribe. By enhancing the metamodel in which the methods are defined, we automatically produce a CASE tool (so to speak) for the applications of these methods. Our results are successfully employed in a number of large, ongoing projects with demonstrable, non-meager saving.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics
文摘In this research we are going to define two new concepts: a) “The Potential of Events” (EP) and b) “The Catholic Information” (CI). The term CI derives from the ancient Greek language and declares all the Catholic (general) Logical Propositions (<img src="Edit_5f13a4a5-abc6-4bc5-9e4c-4ff981627b2a.png" width="33" height="21" alt="" />) which will true for every element of a set A. We will study the Riemann Hypothesis in two stages: a) By using the EP we will prove that the distribution of events e (even) and o (odd) of Square Free Numbers (SFN) on the axis Ax(N) of naturals is Heads-Tails (H-T) type. b) By using the CI we will explain the way that the distribution of prime numbers can be correlated with the non-trivial zeros of the function ζ(s) of Riemann. The Introduction and the Chapter 2 are necessary for understanding the solution. In the Chapter 3 we will present a simple method of forecasting in many very useful applications (e.g. financial, technological, medical, social, etc) developing a generalization of this new, proven here, theory which we finally apply to the solution of RH. The following Introduction as well the Results with the Discussion at the end shed light about the possibility of the proof of all the above. The article consists of 9 chapters that are numbered by 1, 2, …, 9.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, is a home for original research papers of the highest quality in ,all areas of pure and applied mathematics. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the Transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
文摘Journal overview： Journal of Mathematical Research with Applications （JMRA）, formerly Journal of Mathematical Research and Exposition （JMRE） created in 1981, one of the Transactions of China Society for Industrial and Applied Mathematics, is a home for original research papers of the highest quality in all areas of mathematics with applications. The target audience comprises： pure and applied mathematicians, graduate students in broad fields of sciences and technology, scientists and engineers interested in mathematics.
