Download or read book Life Sciences Research to Product Development written by Pronobesh Chattopadhyay and published by CRC Press. This book was released on 2024-03-07 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Business of Bioscience written by Craig D. Shimasaki and published by Springer Science & Business Media. This book was released on 2009-09-18 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Future of Pharmaceutical Product Development and Research written by and published by Academic Press. This book was released on 2020-09-02 with total page 974 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Design Development of Biological Chemical Food and Pharmaceutical Products written by Johannes A. Wesselingh and published by John Wiley & Sons. This book was released on 2007-09-27 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and Development of Biological, Chemical, Food and Pharmaceutical Products has been developed from course material from the authors’ course in Chemical and Biochemical Product Design which has been running at the Technical University Denmark for years. The book draws on the authors’ years of experience in academia and industry to provide an accessible introduction to this field, approaching product development as a subject in its own right rather than a sideline of process engineering In this subject area, practical experience is the key to learning and this textbook provides examples and techniques to help the student get the best out of their projects. Design and Development of Biological, Chemical, Food and Pharma Products aims to aid students in developing good working habits for product development. Students are challenged with examples of real problems that they might encounter as engineers. Written in an informal, student-friendly tone, this unique book includes examples of real products and experiences from real companies to bring the subject alive for the student as well as placing emphasis on problem solving and team learning to set a foundation for a future in industry. The book includes an introduction to the subject of Colloid Science, which is important in product development, but neglected in many curricula. Knowledge of engineering calculus and basic physical chemistry as well as basic inorganic and organic chemistry are assumed. An invaluable text for students of product design in chemical engineering, biochemistry, biotechnology, pharmaceutical sciences and product development. Uses many examples and case studies drawn from a range of industries. Approaches product development as a subject in its own right rather than a sideline of process engineering Emphasizes a problem solving and team learning approach. Assumes some knowledge of calculus, basic physical chemistry and basic transport phenomena as well as some inorganic and organic chemistry.

Download or read book Bioentrepreneurship and Transferring Technology Into Product Development written by Agarwal, Swati and published by IGI Global. This book was released on 2021-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biomedical Product Development Bench to Bedside written by Babak Arjmand and published by Springer Nature. This book was released on 2020-02-05 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

Download or read book Contract Research and Development Organizations written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2011-08-04 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

Download or read book International Entrepreneurship in the Life Sciences written by Marian V. Jones and published by Edward Elgar Publishing. This book was released on 2011-11-01 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'The processes of internationalization, innovation and venture-creation in high-technology new ventures are inextricably intertwined. This is particularly true in the uncertain and troubled waters of the life sciences industry where startups with very uncertain futures are required to face significant challenges in short windows of opportunity. Navigating these waters is not straightforward, either for those immediately involved in it, or for those trying to understand it. This book is a must-read for anyone who is serious about understanding entrepreneurship in the biotechnology industry.' Alberto Onetti, CrESIT (Research Center for Innovation and Life Science Management), Italy In this thought-provoking book, leading experts explore why international entrepreneurship is important to the life sciences industry. From multi-disciplinary and cross-national perspectives, they question why international entrepreneurship scholars might usefully invest interest in research focused on one specific industry context. The book addresses contemporary challenges of relevance to life science firms and draws on leading-edge debates in international entrepreneurship research. Topics include: the nature of the born-global firm; the development of international capabilities and competencies; the role of local and international partnerships and alliances; competitiveness, opportunity recognition and orientation; and the role of specialized complementary assets in internationalization. It concludes by proposing an agenda for future research across the underpinning fields of innovation, entrepreneurship and internationalization. This book will prove a stimulating read for academics, students and researchers with an interest in international business, management and entrepreneurship, as well as for practitioners in the health professions or life sciences academics who are, or may become, entrepreneurs.

Download or read book Innovation Regional Development and the Life Sciences written by Kean Birch and published by Routledge. This book was released on 2016-10-14 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Examining the Impact of Real World Evidence on Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-05-05 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Download or read book Experimental Design for the Life Sciences written by Graeme D. Ruxton and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing students with clear and practical advice on how best to organise experiments and collect data so as to make the subsequent analysis easier and their conclusions more robust, this text assumes no specialist knowledge.

Download or read book Life Sciences Industry written by Basanta Kumara Bahera and published by Springer. This book was released on 2021-08-25 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic principles of applied life sciences such as recombinant DNA technology is used in most life sciences industries marketing bio-formulations for designing more effective protein-based drugs, such as erythropoietin and fast-acting insulin etc. In recent times genetically engineered host cells from mammal, animal and plants are also being used in life sciences industries to manufacture biologics. This book discusses the most basic as well advanced issues on biological products for successfully managing a life sciences industry. It elucidates the life cycle of biological molecules, right from the conceptual development of different types of biopolymers, and their subsequent transfer from the conical flasks in laboratory to life sciences industries for large scale production and marketing. It focuses on sustainable longevity in the life cycle of commercial biopolymers. Cumulative facts and figures in this volume would immensely help in inspiring life sciences industry promoters to monitor value chain transfer process of biologics for better profitability. Additionally, it would serve as a perusal document for the students and researchers interested in entrepreneurial ventures or having their own start-up projects for the commercialization of biologics.

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Download or read book NASA Historical Data Book written by and published by . This book was released on 1988 with total page 1080 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Life Sciences Industry written by Basanta Kumara Bahera and published by Springer Nature. This book was released on 2021-08-24 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic principles of applied life sciences such as recombinant DNA technology is used in most life sciences industries marketing bio-formulations for designing more effective protein-based drugs, such as erythropoietin and fast-acting insulin etc. In recent times genetically engineered host cells from mammal, animal and plants are also being used in life sciences industries to manufacture biologics. This book discusses the most basic as well advanced issues on biological products for successfully managing a life sciences industry. It elucidates the life cycle of biological molecules, right from the conceptual development of different types of biopolymers, and their subsequent transfer from the conical flasks in laboratory to life sciences industries for large scale production and marketing. It focuses on sustainable longevity in the life cycle of commercial biopolymers. Cumulative facts and figures in this volume would immensely help in inspiring life sciences industry promoters to monitor value chain transfer process of biologics for better profitability. Additionally, it would serve as a perusal document for the students and researchers interested in entrepreneurial ventures or having their own start-up projects for the commercialization of biologics.

Download or read book Issues in Radiation Biology and Toxicology Research 2011 Edition written by and published by ScholarlyEditions. This book was released on 2012-01-09 with total page 714 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues in Radiation Biology and Toxicology Research: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Radiation Biology and Toxicology Research. The editors have built Issues in Radiation Biology and Toxicology Research: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Radiation Biology and Toxicology Research in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Radiation Biology and Toxicology Research: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Download or read book New World Situation New Directions in Concurrent Engineering written by Jerzy Pokojski and published by Springer Science & Business Media. This book was released on 2010-11-02 with total page 599 pages. Available in PDF, EPUB and Kindle. Book excerpt: The proceedings contain papers accepted for the 17th ISPE International Conference on Concurrent Engineering, which was held in Cracow, Poland, September 6-10, 2010. Concurrent Engineering (CE) has a history of over twenty years. At first, primary focus was on bringing downstream information as much upstream as possible, by introducing parallel processing of processes, in order to prevent errors at the later stage which would sometimes cause irrevocable damage and to reduce time to market. During the period of more than twenty years, numerous new concepts, methodologies and tools have been developed. During this period the background for engineering/manufacturing has changed extensively. Now, industry has to work with global markets. The globalization brought forth a new network of experts and companies across many different domains and fields in distributed environments. These collaborations integrated with very high level of profesionalism and specialisation, provided the basis for innovations in design and manufacturing and succeeded in creating new products on a global market.