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论我国新药生产市场准入制度的完善
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作者 蒋慧 《学术论坛》 CSSCI 北大核心 2013年第2期151-154,共4页
药品市场准入制度是国家为了实现药品安全性、有效性等目标而在药品生产者、经营者以及药品进入市场时设定必须遵守的规则和必须履行的程序。目前,我国对药品市场准入的监管体系尚不完善,尤其对新药市场准入的相关监管仍有不尽人意之处... 药品市场准入制度是国家为了实现药品安全性、有效性等目标而在药品生产者、经营者以及药品进入市场时设定必须遵守的规则和必须履行的程序。目前,我国对药品市场准入的监管体系尚不完善,尤其对新药市场准入的相关监管仍有不尽人意之处。本文在借鉴国外立法的基础上,对完善我国新药的市场准入制度进行了探讨。 展开更多
关键词 新药 新药生产 市场准入 政府监管
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中国药业如何利用专利期生产“洋药”
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作者 宗灵 《国际医药卫生导报》 2002年第06A期10-10,共1页
全球医药行业今年出现大调整,世界排名前列的葛兰素威康和史克必成、辉瑞公司和华纳兰博特、赫斯特和罗纳等,或联合,或兼并,或换股,都进行了不同程度的重组。 在这次调整大潮中,中国倍受追捧——杜邦把医药中间体转移到中国生产;GE准备... 全球医药行业今年出现大调整,世界排名前列的葛兰素威康和史克必成、辉瑞公司和华纳兰博特、赫斯特和罗纳等,或联合,或兼并,或换股,都进行了不同程度的重组。 在这次调整大潮中,中国倍受追捧——杜邦把医药中间体转移到中国生产;GE准备把世界各地的X光机。 展开更多
关键词 制药行业 新药生产 仿制药 专利期
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The status and progress ofrevascularization on clinical applications
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作者 Li Wu Xiaochun Zhang Xiao Ma 《International Journal of Technology Management》 2014年第1期79-81,共3页
The development of biomedicine has offered new prospects for clinical tissue transplantation. In researching tissue engineering products, the key issue is the construction of micro-circulation network and effective in... The development of biomedicine has offered new prospects for clinical tissue transplantation. In researching tissue engineering products, the key issue is the construction of micro-circulation network and effective induction of angiogenesis is the current continuous explore direction. Revascularization strategy currently focuses on angiogenesis and angiogenesis, but with the advent of microscopic engineering technology, direct construction of artificial micro-circulation pipe has been a new way of thinking. 展开更多
关键词 REVASCULARIZATION CLINICAL APPLICATIONS
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Erythropoietin: From a Biosimilar to Innovative Products Protected by Industrial Property Assets
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作者 Lien Lopez Matilla Pedro Barzaga Fernandezt Sonia Gonzalez Blanco 《Journal of Pharmacy and Pharmacology》 2017年第9期681-687,共7页
Aim: EPO (erythropoietin) is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO (rhEPO) was the best... Aim: EPO (erythropoietin) is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO (rhEPO) was the best-selling product worldwide, reaching nearly three billion dollars annually. The CIM (center of molecular immunology) produced and sold the rhEPO as commercial strategy to recover the investment made in its new facilities. This work summarizes the inventions that protect the innovative products developed by three Cuban institutions, starting from rhEPO, and the industrial property strategy followed by them. Methods: The information was obtained from the United States Patent, Trademark Office (USPTO) database, Patentscope, Espacenet, patent databases of Center for Pharmaceutical Research and Drug Development (CIDEM) and Cuban Industrial Property Office. Conclusions: The manufacturing process of CIM's EPO has its own patent family. From a manufacturing by product an innovative formulation protected by patent was obtained. There is a patent family around the nasal formulation and it continues enlarging. From a biosimilar pharmaceutical innovative products impacting on human health have been obtained. 展开更多
关键词 ERYTHROPOIETIN ATAXIA pegylated EPO biosimilar.
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鲁喜成,医药产业链革新者
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作者 何乐 《经理人》 2024年第6期74-75,共2页
凭借着敏锐的商业洞察力和不懈的创新精神,鲁喜成创办了多家医药公司,完成了从新药研发所需化合物的供应,到产业链上游的医药中间体研发,再到新药生产的自我升级,为整个产业链的发展注入了新的活力。医药领域从来不缺创新,但它亦是一个... 凭借着敏锐的商业洞察力和不懈的创新精神,鲁喜成创办了多家医药公司,完成了从新药研发所需化合物的供应,到产业链上游的医药中间体研发,再到新药生产的自我升级,为整个产业链的发展注入了新的活力。医药领域从来不缺创新,但它亦是一个高科技、高投入、高风险的赛道,并非所有人都能轻易涉足。 展开更多
关键词 医药公司 医药中间体 新药研发 医药领域 革新者 产业链 创新精神 新药生产
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Chemomics and drug innovation 被引量:1
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作者 XU Jun GU Qiong +8 位作者 LIU HaiBo ZHOU JiaJu BU XianZhang HUANG ZhiShu LU Gui LI Ding WEI DongQing WANG Ling GU LianQuan 《Science China Chemistry》 SCIE EI CAS 2013年第1期71-85,共15页
Chemomics is an interdisciplinary study using approaches from chemoinformatics,bioinformatics,synthetic chemistry,and other related disciplines.Biological systems make natural products from endogenous small molecules ... Chemomics is an interdisciplinary study using approaches from chemoinformatics,bioinformatics,synthetic chemistry,and other related disciplines.Biological systems make natural products from endogenous small molecules (natural product building blocks) through a sequence of enzyme catalytic reactions.For each reaction,the natural product building blocks may contribute a group of atoms to the target natural product.We describe this group of atoms as a chemoyl.A chemome is the complete set of chemoyls in an organism.Chemomics studies chemomes and the principles of natural product syntheses and evolutions.Driven by survival and reproductive demands,biological systems have developed effective protocols to synthesize natural products in order to respond to environmental changes;this results in biological and chemical diversity.In recent years,it has been realized that one of the bottlenecks in drug discovery is the lack of chemical resources for drug screening.Chemomics may solve this problem by revealing the rules governing the creation of chemical diversity in biological systems,and by developing biomimetic synthesis approaches to make quasi natural product libraries for drug screening.This treatise introduces chemomics and outlines its contents and potential applications in the fields of drug innovation. 展开更多
关键词 chemomics CHEMOINFORMATICS BIOINFORMATICS drug innovation biomimetic synthesis
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