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Author: Pronobesh Chattopadhyay
Publisher: CRC Press
ISBN: 1003848095
Category : Medical
Languages : en
Pages : 271
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Book Description
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (US FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). Many researchers either abandon their work in the middle of the process or find it difficult to follow the rules. Therefore, it is not surprising that any biological researcher associated with drug development should have a thorough understanding of regulatory requirements. This volume incorporates all the requisite regulatory norms and provides the latest information on the mandated regulation of herbal medicines. The book covers other obligatory regulatory requirements such as: The legal method and practice of herbal drug products, the roles of Ayurvedic medicines, and the process to obtain regulatory approval. Drug molecules not included in Department of Ayurveda, Yoga, Naturopathy, Unani, Siddha, and homeopathy (AYUSH) but referred to as phytopharmaceuticals are also considered new drugs. The boundary line between food and herbal pharmaceuticals is discussed, as well as pre-clinical toxicity testing, clinical trials, and stability studies in accordance with the rules. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, or regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the herbal drug industry.
Author: Pronobesh Chattopadhyay
Publisher: CRC Press
ISBN: 1003848095
Category : Medical
Languages : en
Pages : 271
Get Book
Book Description
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (US FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). Many researchers either abandon their work in the middle of the process or find it difficult to follow the rules. Therefore, it is not surprising that any biological researcher associated with drug development should have a thorough understanding of regulatory requirements. This volume incorporates all the requisite regulatory norms and provides the latest information on the mandated regulation of herbal medicines. The book covers other obligatory regulatory requirements such as: The legal method and practice of herbal drug products, the roles of Ayurvedic medicines, and the process to obtain regulatory approval. Drug molecules not included in Department of Ayurveda, Yoga, Naturopathy, Unani, Siddha, and homeopathy (AYUSH) but referred to as phytopharmaceuticals are also considered new drugs. The boundary line between food and herbal pharmaceuticals is discussed, as well as pre-clinical toxicity testing, clinical trials, and stability studies in accordance with the rules. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, or regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the herbal drug industry.
Author: Kean Birch
Publisher: Routledge
ISBN: 1317613813
Category : Business & Economics
Languages : en
Pages : 183
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Book Description
The life sciences is an industrial sector that covers the development of biological products and the use of biological processes in the production of goods, services and energy. This sector is frequently presented as a major opportunity for policy-makers to upgrade and renew regional economies, leading to social and economic development through support for high-tech innovation. Innovation, Regional Development and the Life Sciences analyses where innovation happens in the life sciences, why it happens in those places, and what this means for regional development policies and strategies. Focusing on the UK and Europe, its arguments are relevant to a variety of countries and regions pursuing high-tech innovation and development policies. The book’s theoretical approach incorporates diverse geographies (e.g. global, national and regional) and political-economic forces (e.g. discourses, governance and finance) in order to understand where innovation happens in the life sciences, where and how value circulates in the life sciences, and who captures the value produced in life sciences innovation. This book will be of interest to researchers, students and policy-makers dealing with regional/local economic development.
Author: Craig D. Shimasaki
Publisher: Springer Science & Business Media
ISBN: 1441900640
Category : Medical
Languages : en
Pages : 282
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Book Description
My journey into this fascinating field of biotechnology started about 26 years ago at a small biotechnology company in South San Francisco called Genentech. I was very fortunate to work for the company that begat the biotech industry during its formative years. This experience established a solid foundation from which I could grow in both the science and business of biotechnology. After my fourth year of working on Oyster Point Boulevard, a close friend and colleague left Genentech to join a start-up biotechnology company. Later, he approached me to leave and join him in of all places – Oklahoma. He persisted for at least a year before I seriously considered his proposal. After listening to their plans, the opportunity suddenly became more and more intriguing. Finally, I took the plunge and joined this ent- preneurial team in cofounding and growing a start-up biotechnology company. Making that fateful decision to leave the security of a larger company was extremely difficult, but it turned out to be the beginning of an entrepreneurial career that forever changed how I viewed the biotechnology industry. Since that time, I have been fortunate to have cofounded two other biotechnology com- nies and even participated in taking one of them public. During my career in these start-ups, I held a variety of positions, from directing the science, operations, regulatory, and marketing components, to subsequently becoming CEO.
Author: Catherine Prescott
Publisher: CRC Press
ISBN: 1439836078
Category : Law
Languages : en
Pages : 408
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Book Description
Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naive to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry sector that for decades has geared itself to the deve
Author: Johan Sukweenadhi
Publisher: Springer Nature
ISBN: 9464633220
Category : Science
Languages : en
Pages : 170
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Book Description
This is an open access book.Molecular biology has given a great impact in life science investigation. The advances in molecular biology over the last several decades have boosted research and product development in many disciplines of life science, including Biotechnology and Pharmacy. This advances comprise: (1) the progression of more sophisticated techniques in molecular biology with a broad, interdisciplinary applications; (2) the expanding flow of information of technical novelties and scientific discoveries across scientific community; and (3) the development of more sophisticated software and continuously updated databases. This has changed the rationale and approach of experimentations giving rise to revolutionizing discoveries in many fields od science. It has become evident that the deregulation of molecular processes in body is associated with, and in certain circumstances is the direct cause of, a wide range of pathological conditions. It is necessary to mention the biomedical relevance of molecular biology-related investigations for drug discovery and the development of a more personalized medicine. Given the rapidly changing and continuously evolving nature of the molecular biology field, we can anticipate that the revolutionary impact of molecular biology in life sciences is only at the beginning and is far from being finished. To highlight the rapidly growing research and product development in the field of Biotechnology and Pharmacy, the 4th International Conference on Natural Resources and Life Sciences (NRLS)” themed Biotechnology- and pharmacy-driven research and product development is presented. Following the successful program of 1st, 2nd, and 3rd NRLS, we intend to hold the next two-day conference along with a one-day optional workshop in 4th NRLS, as a scientific forum for biotechnology and pharmacy researchers and product developers to discuss the recent advances in the fields and their application. It is a great pleasure to invite you to the forthcoming 4th NRLS Conference, which will be held virtually, on August 24th-25th 2022, and the following onsite workshop on August 26th, 2022.
Author: Wendy Charles
Publisher: Springer Nature
ISBN: 9811929769
Category : Computers
Languages : en
Pages : 349
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Book Description
This book highlights the latest advances on the implementation and adaptation of blockchain technologies in real-world scientific, biomedical, and data applications. It presents rapid advancements in life sciences research and development by applying the unique capabilities inherent in distributed ledger technologies. The book unveils the current uses of blockchain in drug discovery, drug and device tracking, real-world data collection, and increased patient engagement used to unlock opportunities to advance life sciences research. This paradigm shift is explored from the perspectives of pharmaceutical professionals, biotechnology start-ups, regulatory agencies, ethical review boards, and blockchain developers. This book enlightens readers about the opportunities to empower and enable data in life sciences.
Author: Agarwal, Swati
Publisher: IGI Global
ISBN: 1799874133
Category : Business & Economics
Languages : en
Pages : 335
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Book Description
In terms of becoming a successful bioentrepreneur, there is still much more to learn. There are many ways to learn the essential fundamentals of entrepreneurship, including through the mistakes of previous businesses and models. Increased knowledge and a better understanding of what works can be derived from these previous failures and mistakes. Additionally, learning from other bioentrepreneurs can help businesses run successfully. By looking deeper into business models, product development, the fundamental concepts of bioentrepreneurship, and the essential characteristics of bioentrepreneurs, one can become better equipped to understand the role of biological sciences in entrepreneurship, specifically the role of product development. Bioentrepreneurship and Transferring Technology Into Product Development provides a comprehensive understanding of the role of biological sciences, specifically in transforming technology into commercial product. This book compiles the theoretical and practical aspects of bioentrepreneurship and discusses the various factors, including creating business plans, acquiring funding, and successful business models. The chapters also cover areas such as small-scale product development, intellectual property rights, funding schemes for start-ups, and new prospective biotechnology product development. This book is essential for bioentrepreneurs, entrepreneurs, product developers, scientists, practitioners, researchers, academicians, and students interested in product development from a biological science perspective.
Author:
Publisher: Academic Press
ISBN: 0128144556
Category : Medical
Languages : en
Pages : 974
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Book Description
The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques
Author: President's Council of Advisors on Science and Technology (U.S.)
Publisher:
ISBN:
Category : Biotechnology industries
Languages : en
Pages : 20
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Book Description
Author: Jack W. Plunkett
Publisher: Plunkett Research, Ltd.
ISBN: 159392092X
Category : Business & Economics
Languages : en
Pages : 660
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Book Description
Plunkett's Almanac of Middle Market Companies 2008 is designed to be time-saving business development tool for professionals, marketers, sales directors, consultants and strategists seeking to understand and reach middle market American companies. It will also be of great use to placement, recruiting and human resources professionals, as well as professionals working in economic development, lending and media. It covers competitive intelligence, market research and business analysis--everything you need to identify and develop strategies for middle market corporations. Coverage includes all major business sectors, from InfoTech to health care to telecommunications and much more. (We have intentionally omitted retail companies and banks.) These profiles and details on over 500 middle market firms are pulled from our extensive company and industry databases. We also include a business glossary and a listing of business contacts, such as industry associations and government agencies. Next, we profile hundreds of leading middle market companies. Our company profiles include complete business descriptions and up to 27 executives by name and title. Purchasers of either the book or PDF version can receive a free copy of the company profiles database on CD-ROM, enabling key word search and export of key information, addresses, phone numbers and executive names with titles for every company profiled.
