WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies PDF Download
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Author: World Health Organization
Publisher:
ISBN: 9789241547017
Category : Medical
Languages : en
Pages : 53
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Book Description
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.
Author: World Health Organization
Publisher:
ISBN: 9789241547017
Category : Medical
Languages : en
Pages : 53
Get Book Here
Book Description
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.
Author: WHO Expert Committee on Biological Standardization. Meeting
Publisher: World Health Organization
ISBN: 9241209798
Category : Medical
Languages : en
Pages : 382
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Book Description
"The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 17 to 21 October 2011"--Introduction.
Author: World Health Organization. Expert Committee on Biological Standardization
Publisher: World Health Organization
ISBN: 9241209933
Category : Business & Economics
Languages : en
Pages : 282
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Book Description
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/.
Author: Gabor G. Kovacs
Publisher: Cambridge University Press
ISBN: 1316337650
Category : Medical
Languages : en
Pages : 320
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Book Description
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.
Author: John Geigert
Publisher: Springer Nature
ISBN: 3031319095
Category : Science
Languages : en
Pages : 597
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Book Description
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.
Author: Charles L. Wilson Ph.D.
Publisher: CRC Press
ISBN: 1420008471
Category : Medical
Languages : en
Pages : 632
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Book Description
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
Author: Sylvain Lehmann
Publisher: Springer Science & Business Media
ISBN: 9783764324155
Category : Medical
Languages : en
Pages : 240
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Book Description
-There is an acceleration in prion disease research because of the spread of mad cow disease. -This book covers in vitro, cellular, and animal models adapted for the study of TSEs. -Includes bio-saftey procedures.
Author: Prakash Srinivasan Timiri Shanmugam
Publisher: Springer Nature
ISBN: 3030918556
Category : Technology & Engineering
Languages : en
Pages : 382
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Book Description
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241546508
Category : Medical
Languages : en
Pages : 196
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Book Description
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.
Author: Dawn P. Wooley
Publisher: John Wiley & Sons
ISBN: 155581963X
Category : Science
Languages : en
Pages : 759
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Book Description
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.
