In Vitro Diagnostic Industry In China

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In Vitro Diagnostic Industry in China

Author : Haibo Song,Jian'er Yao
Publisher : Springer Nature
Page : 287 pages
File Size : 54,7 Mb
Release : 2021-07-28
Category : Medical
ISBN : 9789811623165

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In Vitro Diagnostic Industry in China by Haibo Song,Jian'er Yao Pdf

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

In Vitro Diagnostic Industry in China

Author : Haibo Song,Jian'er Yao
Publisher : Unknown
Page : 0 pages
File Size : 45,8 Mb
Release : 2021
Category : Electronic
ISBN : 9811623171

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In Vitro Diagnostic Industry in China by Haibo Song,Jian'er Yao Pdf

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

In Vitro Diagnostic Industry in China

Author : Haibo Song,Lizhong Dai
Publisher : Springer Nature
Page : 580 pages
File Size : 42,9 Mb
Release : 2024-01-09
Category : Medical
ISBN : 9789819931101

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In Vitro Diagnostic Industry in China by Haibo Song,Lizhong Dai Pdf

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of twelve parts, including the overview on the IVD industry in China in 2021, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, point-of-care testing, molecular diagnosis, blood and body fluid diagnosis, microbial detection, laboratory assembly line, etc. In this second edition, the new contents added include the development of new coronavirus molecular diagnostic products, flight mass spectrometry, tandem mass spectrometry, tumor markers, ELISA immune reagents, autoimmune diagnostics, concomitant diagnosis, fecal and intestinal microecology detection, pathological diagnosis, raw materials for in vitro diagnostic reagents, standard substances and quality controls for in vitro diagnostic reagents, etc., making the content of the whole book more novel and rich. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

Approaching China's Pharmaceutical Market

Author : Ming Q. Lu
Publisher : Springer
Page : 648 pages
File Size : 42,6 Mb
Release : 2015-07-30
Category : Medical
ISBN : 9783319155760

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Approaching China's Pharmaceutical Market by Ming Q. Lu Pdf

​This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)—including its regulations and registration procedures—and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China’s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.

Companion and Complementary Diagnostics

Author : Jan Trøst Jørgensen
Publisher : Academic Press
Page : 508 pages
File Size : 42,5 Mb
Release : 2019-05-08
Category : Medical
ISBN : 9780128135402

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Companion and Complementary Diagnostics by Jan Trøst Jørgensen Pdf

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. Covers all aspects, from biomarker discovery, to development and regulatory approval Explains the "how to" aspects of companion diagnostics Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

China's Healthcare System and Reform

Author : Lawton Robert Burns,Gordon G. Liu
Publisher : Cambridge University Press
Page : 0 pages
File Size : 52,5 Mb
Release : 2017-01-26
Category : Business & Economics
ISBN : 1107164591

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China's Healthcare System and Reform by Lawton Robert Burns,Gordon G. Liu Pdf

This volume provides a comprehensive review of China's healthcare system and policy reforms in the context of the global economy. Following a value-chain framework, the 16 chapters cover the payers, the providers, and the producers (manufacturers) in China's system. It also provides a detailed analysis of the historical development of China's healthcare system, the current state of its broad reforms, and the uneasy balance between China's market-driven approach and governmental regulation. Most importantly, it devotes considerable attention to the major problems confronting China, including chronic illness, public health, and long-term care and economic security for the elderly. Burns and Liu have assembled the latest research from leading health economists and political scientists, as well as senior public health officials and corporate executives, making this book an essential read for industry professionals, policymakers, researchers, and students studying comparative health systems across the world.

First WHO Model List of Essential In Vitro Diagnostics

Author : World Health Organization
Publisher : World Health Organization
Page : 73 pages
File Size : 46,9 Mb
Release : 2019-05-16
Category : Medical
ISBN : 9789241210263

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First WHO Model List of Essential In Vitro Diagnostics by World Health Organization Pdf

The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.

The selection and use of essential in vitro diagnostics

Author : World Health Organization
Publisher : World Health Organization
Page : 236 pages
File Size : 51,5 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9789241210317

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The selection and use of essential in vitro diagnostics by World Health Organization Pdf

The report of the second meeting of the Strategic Advisory Group of Experts on In Vitro was launched in November 2019 and includes the updated WHO Model List of Essential In Vitro Diagnostics (EDL), which lists 122 in vitro diagnostic categories and incorporates evidence base and expositions of the applications to be included on the EDL and the basis of decisions made to list or reject these IVDs. The evidence is expected to guide countries on constituting their national EDLs. In addition the report also presents decision summaries on suggested edits to the first EDL, recommendations on various matters of in vitro diagnostics including the framework for developing future editions, and proposed actions for implementation of the EDL in regions and countries.

Innovation, Economic Development, and Intellectual Property in India and China

Author : Kung-Chung Liu,Uday S. Racherla
Publisher : Springer Nature
Page : 513 pages
File Size : 54,8 Mb
Release : 2019-09-06
Category : Law
ISBN : 9789811381027

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Innovation, Economic Development, and Intellectual Property in India and China by Kung-Chung Liu,Uday S. Racherla Pdf

This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 48,6 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Commentary on the UN Sales Law (CISG)

Author : Christoph Brunner,Benjamin Gottlieb
Publisher : Kluwer Law International B.V.
Page : 982 pages
File Size : 45,8 Mb
Release : 2019-03-18
Category : Law
ISBN : 9789041199799

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Commentary on the UN Sales Law (CISG) by Christoph Brunner,Benjamin Gottlieb Pdf

Buyers and sellers engaging in the cross-border sale of goods are well-advised to be conversant with the United Nations Convention on Contracts for the International Sale of Goods (CISG), which governs international sales contracts. The CISG has been ratified by 89 states, which together account for over three-quarters of all world trade. This practically-oriented, article-by-article commentary on the CISG will be useful to legal practitioners, counsel and arbitrators dealing with international sales contracts. The in-depth annotations deal extensively with the legal issues likely to arise under each CISG article. The annotations include up-to-date analyses of state court and arbitral decisions, the legal doctrines derived from these decisions, and relevant scholarship to date. Among the issues and topics discussed are the following: interface with national laws; scope of application; obligations of seller and buyer; non-conforming goods and duty to notify; breach of contract and remedies; damages; force majeure exemption; and termination of contract and its consequences. This book is an updated translation of the second German edition of a valued resource in Germany, Switzerland, and Austria, and an authority regularly cited by the Swiss Supreme Court. The commentary is influenced by legal authorities from both civil law and common law backgrounds. Throughout, the contributors refer to the cisg-online.ch database, enabling users to locate decisions easily. User-friendly, focused on practical questions, concise but comprehensive, this article-by-article commentary provides a quick and trenchant overview of existing legal opinions and court/arbitral decisions. It will prove immensely valuable to legal practitioners, facilitating their formulation of reliable solutions to legal problems involving the CISG.

Biotech in China

Author : ROLF. SCHMID,Xin Xiong
Publisher : Jenny Stanford Publishing
Page : 350 pages
File Size : 42,6 Mb
Release : 2021-07-16
Category : Biotechnology
ISBN : 9814877530

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Biotech in China by ROLF. SCHMID,Xin Xiong Pdf

In her quest for a global leadership in science and technology, the People's Republic of China has attained top ranks in the number of scientific publications, "hot papers," or national and international patent applications. This also pertains to fields such as biomedicine, agricultural and industrial biotechnology, as well as environmental monitoring and sanitation. However, analysis of the underlying structures and mechanisms is hindered by the sheer flood of data, by stringent government control of all media, including the internet; and by ambiguities inherent in translation from Chinese. This book tries to overcome these difficulties and provides a concise picture of the biotechnology-related research and development (R&D) in China. The book begins with brief accounts of China's geography, people, and their mindset; her political and administrational structure, economy, and finance; her infrastructure related to science and technology; and her educational system and R&D landscape. It then presents succinct accounts on structures and developments in biomedicine, diagnostics, agriculture, fermented food, bioindustry, and environmental biotechnology, with reference to government, industry, and academia. It finally attempts to predict next steps in Chinese biotechnology, both for the national agenda and in view of China's ambitious global development strategy, the Belt and Road Initiative.

Disease Control Priorities, Third Edition (Volume 6)

Author : King K. Holmes,Stefano Bertozzi,Barry R. Bloom,Prabhat Jha
Publisher : World Bank Publications
Page : 506 pages
File Size : 41,7 Mb
Release : 2017-11-06
Category : Medical
ISBN : 9781464805257

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Disease Control Priorities, Third Edition (Volume 6) by King K. Holmes,Stefano Bertozzi,Barry R. Bloom,Prabhat Jha Pdf

Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.

Nanopharmaceutics

Author : Xing-Jie Liang
Publisher : World Scientific
Page : 605 pages
File Size : 45,6 Mb
Release : 2013
Category : Medical
ISBN : 9789814368674

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Nanopharmaceutics by Xing-Jie Liang Pdf

Nanomaterials, with their unique size-dependent physical and chemical properties, have shown promising advantages as drug and gene delivery vehicles, ultra-sensitive intracellular detectors and novel therapeutic drugs. Nanopharmaceutics is one of the disciplines that will benefit the most from this technology.Nanotechnology will have a revolutionary impact on cancer diagnosis and therapy due to the exceptional characteristics of nanopharmaceutics.This book provides an overview of some tools, methods, and materials of nanotechnology that offer potential applications in pharmaceutics, followed by a series of examples showing applications that are already in development. It may very well inspire researchers to develop a new generation of pharmaceutics with inventive non-traditional approach and employ nanoscale science for the benefit of the patient.

Biotechnology Entrepreneurship

Author : Craig Shimasaki
Publisher : Academic Press
Page : 489 pages
File Size : 41,7 Mb
Release : 2014-04-08
Category : Medical
ISBN : 9780124047471

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Biotechnology Entrepreneurship by Craig Shimasaki Pdf

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a ‘how-to’ for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars Case studies are interspersed throughout each chapter to support key concepts and best practices. Enhanced by use of numerous detailed graphics, tables and flow charts