Download or read book Replacement Reduction and Refinement of Animal Testing in the Quality Control of Human Vaccines written by and published by . This book was released on 2015 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccines are recognised as a highly cost effective tool for preventing infectious diseases. They are derived from biological sources and due to the complexity of composition and heterogeneity of products, vaccine lots undergo legally required quality control before they are released. Traditionally, laboratory animals have played an important role in quality control of vaccines and still, many laboratory animals are used in Europe for this purpose. Over the last decades, Replacement, Reduction and Refinement (3Rs) methods to classical animal tests have been developed by control authorities, academia and vaccine manufacturers. The purpose of this report is to inform the EURL ECVAM stakeholders on ongoing activities in development and validation of 3Rs methods for the quality control of vaccines for human use. The focus of the report is on methods for lot release testing (e.g. safety, pyrogenicity, potency) and projects related to the implementation of the consistency approach to established vaccines such as diphtheria, tetanus, pertussis and rabies vaccines.

Download or read book Laboratory animals in vaccine production and control written by C.F.M. Hendriksen and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: 9. REFERENCES 90 CHAPTER 9: OPPORTUNITIES FOR REPLACEMENT, REDUCTION AND REFINEMENT: HUMAN VIRAL VACCINES 93 1. INTRODUCTION 93 2. TESTS FOR EXTRANEOUS MICROORGANISMS 94 3. MUMPS VACCINE . . . 94 4. HEPATITIS B VACCINE 95 4. 1. Test for freedom from live hepatitis virus 95 4. 2. Potency test 95 5. INFLUENZA VACCINE 96 5. 1. Potency test 96 5. 2. Abnormal-toxicity test 96 6. MEASLES VACCINE. . . . . 96 6. 1. Tests for extraneous agents 97 6. 1. 1. Test for Mycobacterium tuberculosis 97 6. 1. 2. Test for extraneous viruses 97 6. 2. Abnormal-toxicity test 98 7. POLIOMYELITIS VACCINE. . . 99 7. A. Inactivated poliomyelitis vaccine 99 7. A. l. Production. . . . . . 99 7. A. 2. Test for residual live virus 99 7. A. 3. Tests for extraneous agents 100 7. A. 3. l. Test for Mycobacterium tuberculosis . . . . . 100 7. A. 3. 2. Test for extraneous viruses 100 7. A. 4. Tumourigenicity test. . . . . 100 XII 7 . A. 5. Potency test . . . . . . . 101 7. A. 6. Test for abnormal toxicity 102 7. B. Live, oral poliomyelitis vaccine 103 7. B. l. Test for extraneous agents 103 7. B. 2. Test for neurovirulence 105 7. B. 3. Test for abnormal toxicity 106 8. RABIES VACCINE 106 8. 1. Production 106 8. 2. Test for residual live virus 107 8. 3. Tests for extraneous microorganisms 107 8. 3. 1. Test for Mycobacterium tuberculosis 107 8. 3. 2. Tests for extraneous viruses 108 8. 3. 2. 1. In dogs 108 8. 3. 2. 2.

Download or read book Replacement Reduction and Refinement of Animal Experiments in the Development and Control of Biological Products written by Fred Brown and published by S. Karger AG (Switzerland). This book was released on 1996 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past, animal experimentation has played an important part in the development and quality control of immunobiological products. These days, however, concern about animal welfare is growing and, consequently, increasing emphasis is placed on the use of in vitro methods. This book reports the proceedings of a symposium held at the Paul Ehrlich Institute in Langen, Germany, in November 1994, at which the application of the three Rs principle - replacement, reduction and refinement of the use of animal experiments - was evaluated and recommendations were given. A review of the history of animal experimentation is followed by reports of various international organizations (including the European Pharmacopoeia and the World Health Organization) about their activities with respect to upholding the three Rs principle. It is shown that significant progress has been made in the last few years in the fields of pyrogen testing, hormones, blood products and vaccines. Several new in vitro methods for potency, efficacy and safety testing of vaccines are presented and discussed. General problems such as harmonization, statistics and validation, serological methods and cell cultures are also addressed. Demonstrating that sound science and animal welfare are not irreconcilable, this volume is a valuable resource for all those concerned with the development and manufacture of biological products.

Download or read book Alternatives to Animal Testing written by Hajime Kojima and published by Springer. This book was released on 2018-12-27 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.

Download or read book Animal Experimentation Working Towards a Paradigm Change written by Kathrin Herrmann and published by BRILL. This book was released on 2019-04-30 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal experimentation has been one of the most controversial areas of animal use, mainly due to the intentional harms inflicted upon animals for the sake of hoped-for benefits in humans. Despite this rationale for continued animal experimentation, shortcomings of this practice have become increasingly more apparent and well-documented. However, these limitations are not yet widely known or appreciated, and there is a danger that they may simply be ignored. The 51 experts who have contributed to Animal Experimentation: Working Towards a Paradigm Change critically review current animal use in science, present new and innovative non-animal approaches to address urgent scientific questions, and offer a roadmap towards an animal-free world of science.

Download or read book Advancing Science and Elimination of the Use of Laboratory Animals for the Development and Control of Vaccines and Hormones written by Fred Brown and published by S. Karger AG (Switzerland). This book was released on 2002 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal experimentation plays a major role in the development and control of biological products and large numbers of animals are used for routine batch control. During the past few years considerable attention has been paid to the concept of replacing, reducing and refining (the three Rs) the use of animals for this purpose. This volume contains the proceedings of an international meeting held in Utrecht in November 2001 in which the problems associated with applying the three Rs were discussed. Particular emphasis was given to the validation and regulatory acceptance of in vitro methods and new concepts of quality control. Those issues are important for the scientific community at large as well as manufacturers, regulatory authorities and everyone concerned with animal welfare.

Download or read book Animals in Biomedical Research written by Coenraad F. M. Hendriksen and published by Elsevier Publishing Company. This book was released on 1991 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: This selection of articles reflects the growing concern for experimental animals and the continuing moral dilemma surrounding the use of animals in research. The increase in knowledge, improvement of health care and creation of useful products that is derived from experimentation on animals, carries the cost of pain and distress that the animals experience, but if such experimentation was not carried out, the alleviation of suffering in the longterm for both man and animals would not be possible. This book addresses on a technical and scientific level, the obligations that man has to animals and to their welfare. It provides insight and information on the high level of professionalism required in the handling of research animals and discusses whether the use of animals in research could be reduced, replaced or refined so as to limit distress. Experimental scientists will find the articles of interest in their endeavor to minimise distress by improving the scientific quality of experimental work.

Download or read book The Principles of Humane Experimental Technique written by William Moy Stratton Russell and published by Hyperion Books. This book was released on 1992 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guide for the Care and Use of Laboratory Animals written by National Research Council and published by National Academies Press. This book was released on 2011-01-27 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.

Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by . This book was released on 2005 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Committee reports on general issues discussed and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterisation and establishment of international and other biological reference standards.

Download or read book Management of Animal Care and Use Programs in Research Education and Testing written by Robert H. Weichbrod and published by CRC Press. This book was released on 2017-09-07 with total page 917 pages. Available in PDF, EPUB and Kindle. Book excerpt: AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

Download or read book Critical Needs for Research in Veterinary Science written by National Research Council and published by National Academies Press. This book was released on 2005-10-18 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research in veterinary science is critical for the health and well-being of animals, including humans. Food safety, emerging infectious diseases, the development of new therapies, and the possibility of bioterrorism are examples of issues addressed by veterinary science that have an impact on both human and animal health. However, there is a lack of scientists engaged in veterinary research. Too few veterinarians pursue research careers, and there is a shortage of facilities and funding for conducting research. This report identifies questions and issues that veterinary research can help to address, and discusses the scientific expertise and infrastructure needed to meet the most critical research needs. The report finds that there is an urgent need to provide adequate resources for investigators, training programs, and facilities involved in veterinary research.

Download or read book The International Encyclopedia of Primatology 3 Volume Set written by Agustín Fuentes and published by John Wiley & Sons. This book was released on 2017-04-24 with total page 1596 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Encyclopedia of Primatology represents the first comprehensive encyclopedic reference focusing on the behaviour, biology, ecology, evolution, genetics, and taxonomy of human and non-human primates. Represents the first comprehensive encyclopedic reference relating to primatology Features more than 450 entries covering topics ranging from the taxonomy, history, behaviour, ecology, captive management and diseases of primates to their use in research, cognition, conservation, and representations in literature Includes coverage of the basic scientific concepts that underlie each topic, along with the latest advances in the field Highly accessible to undergraduate and graduate students in primatology, anthropology, and the medical, biological and zoological sciences Essential reference for academics, researchers and commercial and conservation organizations This work is also available as an online resource at www.encyclopediaofprimatology.com

Download or read book Drug Discovery and Evaluation Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Download or read book Applied Ethics in Animal Research written by John P. Gluck and published by Purdue University Press. This book was released on 2002 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is a collection of chapters all contributed by individuals who have presented their ideas at conferences and who take moderate stands with the use of animals in research. Specifically the chapters bear of the issues of: notions of the moral standings of animals, history of the methods of argumentation, knowledge of the animal mind, nature and value of regulatory structures, how respect for animals can be converted from theory to action in the laboratory. The chapters have been tempered by open discussion with individuals with different opinions and not audiences of true believers. It is the hope of all, that careful consideration of the positions in these chapters will leave reader with a deepened understanding--not necessarily a hardened position.

Download or read book The Ethics of Research Involving Animals written by and published by . This book was released on 2005-01-01 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: A report of the Nuffield Council on Bioethics working party investigating the ethical issues of research involving animals.

Download or read book Alternatives To Animal Testing written by R E Hester and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal experimentation has long been a controversial issue with impassioned arguments on both sides of the debate. Increasingly it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved. Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics include; the safety evaluation of chemicals, international validation and barriers to the validation of alternative tests, in vitro testing for endocrine disruptors, intelligent approaches to safety evaluation of chemicals, alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate students wishing to pursue a career in the pharmaceutical and cosmetic industries.