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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 Here
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: 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:
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: Johannes A. Wesselingh
Publisher: John Wiley & Sons
ISBN: 0470517786
Category : Technology & Engineering
Languages : en
Pages : 310
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Book Description
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.
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: Babak Arjmand
Publisher: Springer Nature
ISBN: 3030356264
Category : Medical
Languages : en
Pages : 164
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Book Description
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.
Author: Marian V. Jones
Publisher: Edward Elgar Publishing
ISBN: 1849808201
Category : Business & Economics
Languages : en
Pages : 361
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Book Description
'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.
Author: Richard Earle
Publisher: CRC Press
ISBN: 9780849312090
Category : Technology & Engineering
Languages : en
Pages : 402
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Book Description
Product development, from refining an established product range to developing completely new products, is the lifeblood of the food industry. It is, however, a process fraught with risk, often ending in failure. What are the keys to making the process a success? Based on a wealth of experience gathered over 40 years, Food Product Development provides the answers. After an introductory chapter, the first half of the book considers the four core elements of product development: the overall business strategy which directs product development, the various steps in the product development process itself, the knowledge required to fuel the process and, last but not least, keeping product development focused on consumer needs and aspirations. The second part of the book looks at managing the product development process in practice with four case studies of successful product launches. It also discusses how to evaluate and improve the process to make future product innovation more successful. Filled with examples and practical suggestions, and written by a distinguished team with unrivalled academic and industry expertise, Food Product Development will be an essential guide for R & D and product development staff, and all managers concerned with this key issue throughout the food industry. Mary D. Earle and Richard L. Earle are both Professors Emeritus in Massey University, New Zealand. Mary Earle is a pioneer in product development research, and both she and her husband have worked with industry on numerous product development projects. Allan M. Anderson is Chief Executive of the New Zealand Dairy Research Institute, the central R & D organisation for the New Zealand dairy industry, and has extensive experience of managing successful product development projects.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030948832X
Category : Medical
Languages : en
Pages : 231
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Book Description
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.
Author: Shayne C. Gad
Publisher: Springer Science & Business Media
ISBN: 146140049X
Category : Medical
Languages : en
Pages : 213
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Book Description
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.
