In 2015, a previously unknown manuscript was discovered in the Nanjing Library. It contained a Chinese mining and metallurgy handbook, and was identified as a copy of the Kunyu gezhi 坤輿格致, known as the lost Chines...In 2015, a previously unknown manuscript was discovered in the Nanjing Library. It contained a Chinese mining and metallurgy handbook, and was identified as a copy of the Kunyu gezhi 坤輿格致, known as the lost Chinese translation of Georgius Agricola’s(1494–1555) De re metallica(1556) by Jesuit Adam Schall von Bell(1592–1666). A closer look at the text, however, reveals that, besides parts of Agricola’s book, content by at least four other European authors was included: Vannoccio Biringuccio(1480–1539), Modestinus Fachs(?–before 1595), Lazarus Ercker(1528/30–1594), and José de Acosta(1539/40–1599/1600). This study demonstrates how their books became available in China, why they were selected as sources for the Kunyu gezhi, and how they were eventually used and incorporated. From this, it becomes apparent that Schall and his collaborators spared no effort to conduct this ambitious knowledge transfer project, and to present European technology at its best to the emperor.展开更多
The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significane...The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.展开更多
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
基金This research is part of“Translating Western Science,Technology and Medicine to Late Ming China:Convergences and Divergences in the Light of the Kunyu gezhi坤輿格致(Investigations of the Earth’s Interior1640)and the Taixi shuifa泰西水法(Hydromethods of the Great West1612),”a project supported by the German Research Foundation(DFG)from 2018 to 2021.
文摘In 2015, a previously unknown manuscript was discovered in the Nanjing Library. It contained a Chinese mining and metallurgy handbook, and was identified as a copy of the Kunyu gezhi 坤輿格致, known as the lost Chinese translation of Georgius Agricola’s(1494–1555) De re metallica(1556) by Jesuit Adam Schall von Bell(1592–1666). A closer look at the text, however, reveals that, besides parts of Agricola’s book, content by at least four other European authors was included: Vannoccio Biringuccio(1480–1539), Modestinus Fachs(?–before 1595), Lazarus Ercker(1528/30–1594), and José de Acosta(1539/40–1599/1600). This study demonstrates how their books became available in China, why they were selected as sources for the Kunyu gezhi, and how they were eventually used and incorporated. From this, it becomes apparent that Schall and his collaborators spared no effort to conduct this ambitious knowledge transfer project, and to present European technology at its best to the emperor.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.
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.
