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Guidelines For The Regulation Of Veterinary Biologics Produced By Biotechnology
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Book Synopsis Guidelines for the Regulation of Veterinary Biologics Produced by Biotechnology by : Bakhshish Singh Samagh
Download or read book Guidelines for the Regulation of Veterinary Biologics Produced by Biotechnology written by Bakhshish Singh Samagh and published by . This book was released on 1989 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Animal Biotechnology by : National Research Council
Download or read book Animal Biotechnology written by National Research Council and published by National Academies Press. This book was released on 2002-12-29 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.
Book Synopsis Biologics Development by : Mark P. Mathieu
Download or read book Biologics Development written by Mark P. Mathieu and published by Parexel International Corporation. This book was released on 1993 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309452058 Total Pages :231 pages Book Rating :4.3/5 (94 download)
Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Guidelines for the Release Into the Environment of Genetically Modified Organisms by : International Office of Epizootics
Download or read book Guidelines for the Release Into the Environment of Genetically Modified Organisms written by International Office of Epizootics and published by Bib. Orton IICA / CATIE. This book was released on 1991 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis FDA Biotechnology Inspection Guide by : United States. Food and Drug Administration
Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Applications of Gene-Based Technologies for Improving Animal Production and Health in Developing Countries by : Harinder P.S. Makkar
Download or read book Applications of Gene-Based Technologies for Improving Animal Production and Health in Developing Countries written by Harinder P.S. Makkar and published by Springer Science & Business Media. This book was released on 2005-08-12 with total page 787 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern Biotechnology has potential for solving many problems associated with animal productivity and health and offers exciting opportunities for enhancing agricultural productivity. At present the focus is, however, on the issues and problems of significance for livestock producers in the developed world. In order to fully realize the benefits of this technology in developing countries, there is a need to identify, characterize and apply appropriate gene-based technologies for these regions. These proceedings present peer reviewed state-of-the-art papers describing the achievements in the areas of animal breeding and genetics, animal nutrition, animal health, and environment, ethics, safety, and regulatory aspects of gene-based technologies; achievements which could be realized using these modern scientific tools to maximise the benefits from the 'livestock revolution' that is taking place; and the constraints in the use of gene-based technologies and their specific research needs. This book will help in bridging the wide gap between developed and developing countries, in the development and use of gene-based technologies, and to elucidate the current and future roles of such technologies in the developing world. It is a good reference source for researchers, students and policy-makers alike.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis Fundamentals of Biologicals Regulation by : Rebecca Sheets
Download or read book Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 2017-12-01 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
Book Synopsis Veterinary Vaccines by : Samia Metwally
Download or read book Veterinary Vaccines written by Samia Metwally and published by John Wiley & Sons. This book was released on 2021-04-01 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a concise and authoritative reference on the use of vaccines against diseases of livestock Compiled by Senior Animal Health Officers at The Food and Agriculture Organization of the United Nations, and with contributions from international leading experts, Veterinary Vaccines: Principles and Applications is a concise and authoritative reference featuring easily readable reviews of the latest research in vaccinology and vaccine immune response to pathogens of major economic impact to livestock. It covers advice and recommendations for vaccine production, quality control, and effective vaccination schemes including vaccine selection, specifications, vaccination programs, vaccine handling in the field, application, failures, and assessment of herd protection. In addition, the book presents discussions on the current status and potential future developments of vaccines and vaccination against selected transboundary animal diseases. Provides a clear and comprehensive guide on using veterinary vaccines to protect livestock from diseases Teaches the principles of vaccinology and vaccine immune response Highlights the vaccine production schemes and standards for quality control testing Offers easy-to-read reviews of the most current research on the subject Gives readers advice and recommendations on which vaccination schemes are most effective Discusses the today’s state of vaccines and vaccination against selected transboundary animal diseases as well as possible future developments in the field Veterinary Vaccines: Principles and Applications is an important resource for veterinary practitioners, animal health department officials, vaccine scientists, and veterinary students. It will also be of interest to professional associations and NGO active in livestock industry.
Book Synopsis Guideline on General Principles of Process Validation by :
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biology of Rice written by S. Tsunoda and published by Elsevier. This book was released on 2012-12-02 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a wealth of both general and specific information about rice. The first section outlines the distribution and mutual relationships of various types of rice with special attention to the adaptive strategy of wild and cultivated rice, and to the relationships between different ecotypes and their adaptation to low temperature, different photoperiods or different humidities. The section on rice morpho-physiology compares the characteristics of rice and dry land crops and different ecotypes with regard to seed dormancy and germination; describes the important steps in the photosynthetic structure process and its adjustment to the course of evolution of cultivated rice; studies the root and nutrient uptake and the responses to hormones in terrestrial and aquatic plants; considers the reproductive nature in relation to tolerance to environmental stress; and discusses the morphological characteristics of rice panicle in relation to grain filling, sink-source balance and variation in yield components of panicle structure. The last section reviews the genetics of rice and includes new findings on chromosomal analysis, cytoplasmic analysis and gene analysis and reviews recent achievements in tissue culture and genetic engineering techniques.The book is authoritative, well-documented and international in scope. It presents new and useful information of direct use to rice research workers and students, and of interest to crop physiologists, agronomists, plant physiologists and breeders throughout the world.
Book Synopsis Drug Biotechnology Regulation by : Y. Chiu
Download or read book Drug Biotechnology Regulation written by Y. Chiu and published by CRC Press. This book was released on 1991-01-07 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: An examination of the relation between biodrug development and governmental regulation, focusing on the present state of collective knowledge of biotechnological practitioners, including the identification of the scientific basis on regulatory requirements in the field, as well as ways in which the
Book Synopsis Safety of Genetically Engineered Foods by : National Research Council
Download or read book Safety of Genetically Engineered Foods written by National Research Council and published by National Academies Press. This book was released on 2004-07-08 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them. The book offers a framework to guide federal agencies in selecting the route of safety assessment. It identifies and recommends several pre- and post-market approaches to guide the assessment of unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps.
Download or read book Code of Federal Regulations written by and published by . This book was released on 1995 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Regulatory Aspects of Gene Therapy and Cell Therapy Products by : Maria Cristina Galli
Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer. This book was released on 2015-09-15 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Book Synopsis An Overview of FDA Regulated Products by : Eunjoo Pacifici
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
