Download or read book Biotechnology And Safety Assessment written by J A Thomas and published by CRC Press. This book was released on 1998-11-17 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated text explains how advances in mammalian and plant genetics contribute to better therapeutics agents and more wholesome foods. It addresses such topics as new pharmaceutical agents, agribiotechnology, safety evaluation of biotechnology-derived drugs, food safety, nutritional science, and regulatory and environmental aspects of genetically-modified organisms. New to this edition are chapters on biotherapeutics and herbicide-resistant crops. It should be of interest to biotechnology, toxicologists, pharmaceutical scientists, environmental scientists and agriculturists.

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 Safety Assessment of Transgenic Organisms written by OECD. and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book Biotechnology and Safety Assessment written by J. A. Thomas and published by CRC Press. This book was released on 2020-12-18 with total page 637 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly updated and revised, this second edition of Biotechnology and Safety Assessment represents a timely update on the rapidly moving field of biopharmaceutics. While the focus is on the therapeutic potentials of various cytokines and antisense agents, the book also identifies some of the toxicologic considerations of interferons and of genetically engineered food. Experts front academia, industry, and government address risk assessment and environmental issues associated with the expanding worldwide consumption of genetically engineered foodstuffs. A series of contemporary views are also offered on the advances in both mammalian and plant genetics and how these advances contribute to safer biotherapeutic agents and more nutritious foods. Toxicologists, pharmacologists, regulatory agency professionals, environmental scientists, nutritionists, and agricultural specialists will find this book to be an essential reference on the biotechnology and toxicological safety assessment of drugs and other xenobiotics. Book jacket.

Download or read book Food Safety of Proteins in Agricultural Biotechnology written by Bruce G. Hammond and published by CRC Press. This book was released on 2007-11-28 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from internationally recognized experts, Food Safety of Proteins in Agricultural Biotechnology comprehensively addresses how toxicology testing of proteins should be accomplished and how protein safety assessments should be carried out. Beginning with a background on protein biology, the book delineates the fundamental difference

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 Safety Assessment of Transgenic Organisms in the Environment Volume 8 written by Organisation for Economic Co-operation and Development and published by . This book was released on 2018 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume 8 of the Series contains the first biosafety 'consensus document' to deal with the biology of an insect, the mosquito Aedes aegypti. Issued by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology, the science-based consensus documents collate information for use during the regulatory risk assessment of biotechnology products, i.e. transgenic organisms (plants, animals, micro-organisms) when intended for release in the environment. Ae. aegypti mosquito is vectoring yellow fever, dengue, Zika and Chikungunya diseases in tropical and sub-tropical regions worldwide. Biotechnological applications are developed to control the mosquito population and reduce virus transmission. The book provides information on Ae. aegypti taxonomy, morphology, life cycle, reproductive biology, genetics, ecology, interactions with other species and the environment. The mosquito effects on human and animal health, and the control strategies/specific programmes to limit its development are also summarised.

Download or read book Genetically Modified Food Sources written by Victor Tutelyan and published by Academic Press. This book was released on 2013-05-06 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetically Modified Food Sources reports detailed results of studies on the medical and biological safety of 14 species of genetically modified plant-derived organisms (GMOs). The authors focus on issues in GMO production and world output, specifically the basic legislative regulations of modern biotechnology in the Russian Federation. Also covered are international approaches to the medical and biological assessment of safety and control of the food produced from genetically modified organisms. A special chapter is devoted to the problem of informational coverage of novel biological technologies. Previously available only in a 2007 Russian-language edition published by the Russian Academy of Medical Sciences, this English translation has been completely revised and updated to include the latest developments in regulations and human and animal safety assessment practices. The book is addressed to a wide community of specialists working in the fields of food science, plant genetics, and food safety as well as medicine and biology. Students and postgraduates focusing on the problems of modern biotechnology and biological safety will find it a valuable guide to these topics. Specific assessments of 14 species of genetically modified plant-derived organisms used for food supply Addresses the safety assessment requirements to ensure consumer health International coverage provides comparative insights into regulation development and application

Download or read book Safety in Industrial Microbiology and Biotechnology written by C. H. Collins and published by Elsevier. This book was released on 2015-09-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety in Industrial Microbiology and Biotechnology reviews the hazards involved in work with both naturally occurring and genetically-modified microorganisms. This text is divided into 12 chapters and begins with an overview of the laboratory- and industry-associated infection hazards. The subsequent chapters deal with the legal issues, containment, risk assessment, and pathogenicity testing of infection related to industrial microbiology and biotechnology. These topics are followed by discussions of the safety considerations in recombinant plasmid preparation, the safe handling of industrially-produced mammalian cells, and some genetic designs that can be applied to processes based on recombinant DNA microorganisms. Other chapters explore the design for safety in bioprocessing and the containment in the development and manufacture of recombinant DNA-derived products. The remaining chapters look into the monitoring and validation in biotechnological processes, as well as the occupational health implications of industrial biotechnology. This book will prove useful to biotechnologists, microbiologists, safety engineers, and researchers.

Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-04-29 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Download or read book Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms Volume 4 OECD Consensus Documents written by OECD and published by OECD Publishing. This book was released on 2010-11-09 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: These OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries and some non members associated with the work.

Download or read book Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment Volume 6 OECD Consensus Documents written by OECD and published by OECD Publishing. This book was released on 2016-04-05 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This series represents a compilation of the biosafety consensus documents developed by the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology over the periods 2011-12 (Volume 5) and 2013-15 (Volume 6).

Download or read book Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms Volume 1 OECD Consensus Documents written by OECD and published by OECD Publishing. This book was released on 2006-07-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: These OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries.

Download or read book Biotechnology Risk Assessment written by J. Fiksel and published by . This book was released on 1986 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biotechnology Risk Assessment written by Joseph Fiksel and published by Elsevier. This book was released on 2013-10-22 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology Risk Assessment: Issues and Methods for Environmental Introductions tackles the environmental concerns associated with utilizing contemporary biotechnology. The title also examines the methods of implementing biotechnology while also minimizing the risks. The text first covers the suitability and applicability of risk assessment methods for environmental applications of biotechnology, and then proceeds to tackling the methods for evaluation of microorganism properties. Next, the selection deals with human exposure to viruses and genetically altered bacteria. The text also tackles the effects of bioengineered organisms on the ecosystem, along with the assessment of the transport and fate of bioengineered microorganisms in the environment. The seventh chapter discusses the analysis of the function and structure of ecosystem, while the eighth chapter details the controlled testing and monitoring methods for microorganisms. The book will be of great use to biotechnologists, microbiologists, ecologists, epidemiologists, and virologists.

Download or read book Novel Food and Feed Safety Safety Assessment of Foods and Feeds Derived from Transgenic Crops Volume 1 written by OECD and published by OECD Publishing. This book was released on 2015-04-03 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: These science-based consensus documents contain information for use during the regulatory assessment of food/feed products of modern biotechnology, i.e. developed from transgenic crops.