Download or read book WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies written by World Health Organization and published by . This book was released on 2006-01-01 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt: These guidelines provide evidence-based information to national regulatory authorities, especially to those where Bovine Spongiform Encephalopathy (BSE) has not yet been reported and where surveillance systems for BSE and variant Creutzfeldt-Jakob disease (vCJD), the human disease caused by infection with the BSE agent, may not be in place. Preventive measures to minimise the risk of transmitting TSEs to humans from pharmaceutical and biological products in which ruminant animal-derived materials are used and from humans to humans by blood and blood products and by human cells, tissues and organs are discussed.
Download or read book WHO Tables on Tissue Infectivity Distribution in Tramsmissible Spongiform Encephalopathies written by World Health Organization and published by . This book was released on 2010 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Neuropathology of Neurodegenerative Diseases written by Gabor G. Kovacs and published by Cambridge University Press. This book was released on 2017-12-13 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide to the diagnosis of neurodegenerative diseases discusses modern molecular techniques, morphological classification, fundamentals of clinical symptomology, diagnostic pitfalls and immunostaining protocols. It is based on the proteinopathy concept of neurodegenerative disease, which has influenced classification and provides new strategies for therapy. Numerous high-quality images, including histopathology photomicrographs and neuroradiology scans, accompany the description of morphologic alterations and interpretation of immunoreactivities. Diagnostic methods and criteria are placed within recent developments in neuropathology, including the now widespread application of immunohistochemistry. To aid daily practice, the guide includes diagnostic algorithms and offers personal insights from experienced experts in the field. Special focus is given to the way brain tissue should be handled during diagnosis. This is a must-have reference for medical specialists and specialist medical trainees in the fields of pathology, neuropathology and neurology working with neuropathologic features of neurodegenerative diseases.
Download or read book Who Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 17 to 21 October 2011"--Introduction.
Download or read book Human Prion Diseases written by and published by Elsevier. This book was released on 2018-06-07 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human Prion Diseases, Volume 153 is designed to update the reader on the latest advances and clinical aspects of prion diseases. The book is organized into five sections, including the pathophysiology of prions and a description of animal and human diseases. This is followed by detailed reports on recent advances in diagnosis strategies for the development of novel anti-prion molecules and possible designs of clinical trials in such a rare disease. An introductory chapter gives an extensive historical background of prion research, with a final chapter highlighting recent progress, and more importantly, unsolved problems. Offers an authoritative overview of prion diseases in humans, detailing the pathogenesis of the disease, clinical investigations, and the diagnosis of both the genetic and acquired forms Provides clarity and context by presenting prion diseases in relation to other neurodegenerative diseases in humans Emphasizes the unique properties of prion diseases and consequent problems they can cause, both clinically and in public health terms
Download or read book Safe Management of Wastes from Health care Activities written by Yves Chartier and published by World Health Organization. This book was released on 2014 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).
Download or read book Laboratory Biosafety Manual written by World Health Organization and published by World Health Organization. This book was released on 2004-12-28 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the third edition of this manual which contains updated practical guidance on biosafety techniques in laboratories at all levels. It is organised into nine sections and issues covered include: microbiological risk assessment; lab design and facilities; biosecurity concepts; safety equipment; contingency planning; disinfection and sterilisation; the transport of infectious substances; biosafety and the safe use of recombinant DNA technology; chemical, fire and electrical safety aspects; safety organisation and training programmes; and the safety checklist.
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and published by World Health Organization. This book was released on 2015-06-30 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendations Guidelines and guidance documents. Following these discussions a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above three WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–4). Finally all additions and discontinuations made during the 2014 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer Nature. This book was released on 2023-06-15 with total page 597 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Download or read book Biological Safety written by Dawn P. Wooley and published by John Wiley & Sons. This book was released on 2020-07-02 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological safety and biosecurity protocols are essential to the reputation and responsibility of every scientific institution, whether research, academic, or production. Every risk—no matter how small—must be considered, assessed, and properly mitigated. If the science isn't safe, it isn't good. Now in its fifth edition, Biological safety: Principles and Practices remains the most comprehensive biosafety reference. Led by editors Karen Byers and Dawn Wooley, a team of expert contributors have outlined the technical nuts and bolts of biosafety and biosecurity within these pages. This book presents the guiding principles of laboratory safety, including: the identification, assessment, and control of the broad variety of risks encountered in the lab; the production facility; and, the classroom. Specifically, Biological Safety covers protection and control elements—from biosafety level cabinets and personal protection systems to strategies and decontamination methods administrative concerns in biorisk management, including regulations, guidelines, and compliance various aspects of risk assessment covering bacterial pathogens, viral agents, mycotic agents, protozoa and helminths, gene transfer vectors, zooonotic agents, allergens, toxins, and molecular agents as well as decontamination, aerobiology, occupational medicine, and training A resource for biosafety professionals, instructors, and those who work with pathogenic agents in any capacity, Biological safety is also a critical reference for laboratory managers, and those responsible for managing biohazards in a range of settings, including basic and agricultural research, clinical laboratories, the vivarium, field study, insectories, and greenhouses.
Download or read book Blood Donor Selection written by World Health Organization and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The WHO guidelines on assessing donor suitability for blood donation have been developed to assist blood transfusion services in countries that are establishing or strengthening national systems for the selection of blood donors. They are designed for use by policy makers in national blood programmes in ministries of health, national advisory bodies such as national blood commissions or councils, and blood transfusion services.
Download or read book Red Book Atlas of Pediatric Infectious Diseases written by American Academy of Pediatrics and published by . This book was released on 2007 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on key content from Red Book: 2006 Report of the Committee on Infectious Diseases, 27th Edition, the new Red Bookr Atlas is a useful quick reference tool for the clinical diagnosis and treatment of more than 75 of the most commonly seen pediatric infectious diseases. Includes more than 500 full-color images adjacent to concise diagnostic and treatment guidelines. Essential information on each condition is presented in the precise sequence needed in the clinical setting: Clinical manifestations, Etiology, Epidemiology, Incubation period, Diagnostic tests, Treatment
Download or read book Medical Device Guidelines and Regulations Handbook written by Prakash Srinivasan Timiri Shanmugam and published by Springer Nature. This book was released on 2022-04-22 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
Download or read book Microbial Food Contamination written by Charles L. Wilson Ph.D. and published by CRC Press. This book was released on 2007-10-08 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: Divided into five parts, Microbial Food Contamination, Second Edition looks at emerging foodborne human pathogens andcomprehensively evaluates the microbiology, biochemistry, detection, risk, and threat of foodborne illness in today's global market. The first section introduces new insights into the pathogenic effect of E. coli, viral
Download or read book Prions in Humans and Animals written by Beat Hörnlimann and published by Walter de Gruyter. This book was released on 2009-05-08 with total page 743 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive work, aimed at both students and researchers alike, systematically covers all aspects of prion diseases (transmissible spongiform encephalopathies), from their history, microbiology and pathology to their transmissibility and prevention. The book describes diseases such as Creutzfeldt-Jakob disease, kuru, mad cow disease (BSE), chronic wasting disease and scrapie, highlighting their biochemical, molecular biological, genetic, and clinical aspects. A detailed presentation of the impact of prion diseases in fields such as pharmaceutics, blood products, disinfection, surgical instruments and epidemiology concludes with a discussion of preventive measures. A renowned editorial team, representing the fields of medicine, veterinary medicine and molecular biology, brought together 80 internationally respected authors for this translation and new edition of the successful German publication, not only from relevant research fields, but also from industry and public health institutions. The book includes chapters by, among many other notable scientists, William J. Hadlow, who discovered the relationship between the human and animal forms of prion diseases and Michael P. Alpers, with 45 years of experience in Papua New Guinea investigating the first known human epidemic form, kuru, transmitted by endocannibalism. Further contributions from Gerald A. H. Wells, a veterinary pathologist who described BSE and recognised its similarity to scrapie, thus recording the first cases in 1986 of the most important animal epidemic of modern times, and Robert G. Will, a medical neurologist and epidemiologist who discovered the emergence of the variant form of Creutzfeldt-Jakob disease in 1996, underscore the strength of this author team. Carefully edited with numerous illustrations, this work offers a systematic approach committed to a clear presentation of the current knowledge of prion diseases. It aims to inspire and stimulate interdisciplinary cooperation, innovative research ideas and effective prevention.
Download or read book Neurological Complications of Infectious Diseases written by Rodrigo Hasbun, MD MPH and published by Springer Nature. This book was released on 2020-12-13 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a comprehensive review of the most common infectious diseases that affect the nervous system. Written by international experts, it provides a guide to clinicians for accurately diagnosing and treating these challenging syndromes. Organized into six sections, the book presents didactic, up-to-date information on the following topics relating to central nervous system (CNS) infections: diagnosis and evaluation of the patient, bacterial, viral, fungal and mycobacterial infections, disorders of the spinal cord, and a myriad of miscellaneous infections. Chapters specifically reflect and look to resolve the common obstacles clinicians face in the field, such as having unknown etiologies on the majority of CNS infections, insensitive and slow microbiological techniques, an increasing number of immunosuppressed individuals with atypical presentations and pathogens, and a lack of standardized diagnostic algorithms. A complex yet accessible addition to the Current Clinical Neurology Series, Neurological Complications of Infectious Diseases invaluably examines a wide range of infections that have neurological complications and sequelae.
