Contract Research and Manufacturing Services (CRAMS) in India PDF Download
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Author: Milind Antani
Publisher: Elsevier
ISBN: 1908818166
Category : Medical
Languages : en
Pages : 251
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Book Description
The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. - Simple and accessible presentation using tables, charts and diagrams - Practical tips from leading practitioners - Inclusion of relevant case laws and other legal considerations
Author: Milind Antani
Publisher: Elsevier
ISBN: 1908818166
Category : Medical
Languages : en
Pages : 251
Get Book Here
Book Description
The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. - Simple and accessible presentation using tables, charts and diagrams - Practical tips from leading practitioners - Inclusion of relevant case laws and other legal considerations
Author: Reji K. Joseph
Publisher: Routledge
ISBN: 1317408837
Category : Business & Economics
Languages : en
Pages : 250
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Book Description
This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure — about 60 per cent — and characterised by very high share of medicines in total health expenditure. A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.
Author: U Sahoo
Publisher: Elsevier
ISBN: 1908818131
Category : Medical
Languages : en
Pages : 412
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Book Description
Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research
Author: Murphy Halliburton
Publisher: Cornell University Press
ISBN: 1501713981
Category : Social Science
Languages : en
Pages : 241
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Book Description
India and the Patent Wars contributes to an international debate over the costs of medicine and restrictions on access under stringent patent laws showing how activists and drug companies in low-income countries seize agency and exert influence over these processes. Murphy Halliburton contributes to analyses of globalization within the fields of anthropology, sociology, law, and public health by drawing on interviews and ethnographic work with pharmaceutical producers in India and the United States. India has been at the center of emerging controversies around patent rights related to pharmaceutical production and local medical knowledge. Halliburton shows that Big Pharma is not all-powerful, and that local activists and practitioners of ayurveda, India’s largest indigenous medical system, have been able to undermine the aspirations of multinational companies and the WTO. Halliburton traces how key drug prices have gone down, not up, in low-income countries under the new patent regime through partnerships between US- and India-based companies, but warns us to be aware of access to essential medicines in low- and middle-income countries going forward.
Author: P R Chowdhury
Publisher: Elsevier
ISBN: 1908818018
Category : Medical
Languages : en
Pages : 133
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Book Description
The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. - Constitutes the first ever comprehensive insight on the Indian biopharma sector - Provides a perspective based on practical hands-on legal experience - Simply structured, clearly presented and free from excessive legal jargon
Author: Miroslava Čuperlović-Culf
Publisher: Elsevier
ISBN: 1908818263
Category : Medical
Languages : en
Pages : 446
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Book Description
The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics in cancer research, the book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer, before a concluding chapter discusses future perspectives in the field. - Focused description of NMR spectroscopy needed by cancer biologists who are starting to use metabolomics - Current overview of knowledge related to the cancer metabolic phenotype from the perspective of metabolomics applications - Information about the best practices in NMR metabolomics experimentation and data preprocessing as applied to different sample types
Author: Lee Harland
Publisher: Elsevier
ISBN: 1908818247
Category : Computers
Languages : en
Pages : 583
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Book Description
The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems.The book is divided into four parts. Part one looks at laboratory data management and chemical informatics, covering software such as Bioclipse, OpenTox, ImageJ and KNIME. In part two, the focus turns to genomics and bioinformatics tools, with chapters examining GenomicsTools and EBI Atlas software, as well as the practicalities of setting up an 'omics' platform and managing large volumes of data. Chapters in part three examine information and knowledge management, covering a range of topics including software for web-based collaboration, open source search and visualisation technologies for scientific business applications, and specific software such as DesignTracker and Utopia Documents. Part four looks at semantic technologies such as Semantic MediaWiki, TripleMap and Chem2Bio2RDF, before part five examines clinical analytics, and validation and regulatory compliance of free/open source software. Finally, the book concludes by looking at future perspectives and the economics and free/open source software in industry. - Discusses a broad range of applications from a variety of sectors - Provides a unique perspective on work normally performed behind closed doors - Highlights the criteria used to compare and assess different approaches to solving problems
Author:
Publisher: Academic Press
ISBN: 0128127368
Category : Medical
Languages : en
Pages : 2370
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Book Description
Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos
Author: Subba Rao Chaganti
Publisher: PharmaMed Press / BSP Books
ISBN: 9388305264
Category : Medical
Languages : en
Pages : 720
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Book Description
Pharmaceutical Marketing in India: For Today and Tomorrow is the go-to guide for anyone interested in the pharmaceutical industry in India. With its comprehensive coverage of the sector, this book is a must-read for students, practitioners, and researchers alike. In this updated 25th Anniversary Edition, readers will find new content that covers the latest trends and initiatives in the industry. The book provides a thorough introduction to the changes taking place in first-world markets and the incremental steps being taken by Indian drug majors and their MNC counterparts in India. This book contains seventy-seven cases that highlight the best practices of successful practitioners of Pharma marketing in India. These cases showcase how they have positioned their products, launched and promoted their brands, and defended their therapeutic segments. The insights provided by these cases are incredibly valuable to both practitioners and students of pharmaceutical marketing. The new edition of the book includes information on changing detailing practices such as e-Detailing, iPad detailing, and tablet detailing, digital marketing strategies, social media strategies for the pharmaceutical industry, multichannel marketing, closed-loop marketing, and more. It also covers the latest ways of engaging and building meaningful relationships with physicians, including medical sales liaisons (MSL), key opinion leader (KOL) management, and key account management (KAM). The primary purpose of this edition is to make it not only relevant for today but also for tomorrow. In other words, to make it as future-proof as possible. This book is a vital resource for anyone interested in the pharmaceutical industry and is a must-read for those looking to stay ahead of the curve in this ever-evolving field. Contents: Part One: The Big Picture 1. The Indian Pharmaceutical Industry: An Overview 2. The Pharmaceutical Market Part Two: Ten ‘P’s 3. The Product 4. The Price 5. The Place 6. The Promotion 7. Personal selling 8. The Prescription 9. The Policy 10. Public Relations 11. The Power 12. The Patient Part Three: Key Success Factors 13. Managing New Products 14. The Winning Game Plans 15. Towards Excellence in Marketing 16. The Winning Edge 17. Corporate Scoreboard 18. GMP
Author: Aas Mohammad
Publisher: Cambridge Scholars Publishing
ISBN: 1527540391
Category : Business & Economics
Languages : en
Pages : 224
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Book Description
This book evaluates the performance of the Indian pharmaceutical industry, which plays an important role in economic development. It highlights the role the government has had in facilitating the growth of the industry from non-existence, before the 1970s, to being one of the largest pharmaceutical industries in the world today. The text employs various useful techniques to provide an understanding of productivity and efficiency, such as data envelopment analysis, stochastic frontier analysis, the Malmquist Productivity Index and the Hicks-Moorsteen Productivity Index. The book will be useful to health administrators, students of public policy, and health economists with an interest in the pharmaceutical sector.
