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 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 WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2021-05-06 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: The seventy-second meeting of the WHO Expert Committee on Biological Standardization was held from 19 to 23 October 2020 by WebEx video conferencing due to the restrictions imposed during the coronavirus disease 2019 (COVID-19) pandemic. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvão Simão, Assistant Director-General, Access to Medicines and Health Products. Dr Simão welcomed Committee members, meeting participants and observers. Dr Simão began by noting that the Committee had met as recently as August 2020, primarily to address standardization activities related to COVID-19, and that much remains to be learnt about the pandemic. The WHO Solidarity Trial was continuing to facilitate the rapid and robust comparison of potential treatments. Recently published interim results indicated that the four small molecule treatments remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon had little or no benefit in terms of overall mortality or speed of recovery of hospitalized patients – to date only dexamethasone had proved to be effective against severe COVID-19.
Download or read book Regulation of Biological Control Agents written by Ralf-Udo Ehlers and published by Springer Science & Business Media. This book was released on 2011-02-03 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a comprehensive compilation of registration requirements necessary for authorisation of biological control agents (viruses, bacteria, fungi, active substances of natural origin and semiochemicals) in OECD countries. It also reviews data requirements for invertebrate agents (insect, mites and nematodes) and provides proposals for harmonisation of the regulation process and guidelines for completion of application forms. Based on results of the EU REBECA Policy Support Action, which gathered experts from academia, regulation authorities and industry, risks and benefits of the specific agents were reviewed and proposals for a more balanced registration process elaborated, including recommendations for acceleration of the authorisation process and discussions on trade-off effects and policy impacts. All these aspects are covered in detail in this book, which points the way forward for enhanced utilisation of biological control agents.
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 . 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 Responsible Research with Biological Select Agents and Toxins written by National Research Council and published by National Academies Press. This book was released on 2010-02-12 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.
Download or read book Biological Control written by Roy Van Driesche and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text provides readers with an in-depth exploration of how biological control functions and how it can be safely employed to solve pest problems and enhance nature conservation. It covers the principles behind biological control techniques and their implementation, and incorporates practical examples from the biological control of a variety of pests. It contains detailed chapters on conserving natural enemies through environmental management, importation of new natural enemies for control of pests, augmentation of natural enemies through rearing and release, and the development and application of pathogens and biopesticides.
Download or read book Biological Control Measures of Success written by G. Gurr and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: As well as examining successful biological control programmes this book analyses why the majority of attempts fail. Off-target and other negative effects of biological control are also dealt with. Chapters contributed by leading international researchers and practitioners in all areas of biological control afford the book a breadth of coverage and depth of analysis not possible with a single author volume. Combined with the use of other experts to review chapters and editorial oversight to ensure thematic integrity of the volume, this book provides the most authoritative analysis of biological control published. Key aspects addressed include how success may be measured, how successful biological control has been to date and how may it be made more successful in the future. With extensive use of contemporary examples, photographs, figures and tables this book will be invaluable to advanced undergraduate and postgraduate students as well as being a `must' for all involved in making biological control successful.
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2019-08-13 with total page 271 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 WHO Recommendations to assure the quality safety and efficacy of recombinant hepatitis E vaccines; WHO Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential; and WHO Guidelines for the safe production and quality control of poliomyelitis vaccines were adopted on the recommendation of the Committee. In addition a WHO questions-and-answers guidance document on the evaluation of similar biotherapeutic product (SBPs) was also adopted with the Committee recommending that it be posted on the WHO website. Subsequent sections of the report provide information on the current status proposed development and establishment of international reference materials in the areas of: antibiotics; blood products and related substances; cellular and gene therapies; in vitro diagnostics; standards for use in public health emergencies; 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 for publication on the advice of the Committee are then presented as part of this report (Annexes 2-4). Finally all additions and discontinuations made during the 2018 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 Introduction to Modeling Biological Cellular Control Systems written by Weijiu Liu and published by Springer Science & Business Media. This book was released on 2012-04-26 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook contains the essential knowledge in modeling, simulation, analysis, and applications in dealing with biological cellular control systems. In particular, the book shows how to use the law of mass balance and the law of mass action to derive an enzyme kinetic model - the Michaelis-Menten function or the Hill function, how to use a current-voltage relation, Nernst potential equilibrium equation, and Hodgkin and Huxley's models to model an ionic channel or pump, and how to use the law of mass balance to integrate these enzyme or channel models into a complete feedback control system. The book also illustrates how to use data to estimate parameters in a model, how to use MATLAB to solve a model numerically, how to do computer simulations, and how to provide model predictions. Furthermore, the book demonstrates how to conduct a stability and sensitivity analysis on a model.
Download or read book Integrative Biological Control written by Yulin Gao and published by Springer Nature. This book was released on 2020-08-18 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first to integrate biological control into a conceptual framework – ecostacking - uniting all aspects of biological control and ecosystem services. In 2018 the "First International Congress of Biological Control" was organised and held in Beijing, China. The chapters highlight some of the achievements presented at the congress, worldwide. Of particular significance are the numerous contributions by Chinese researchers illustrating the remarkable progress made on developing and adopting multiple biological control strategies over vast agricultural areas, largely replacing chemical pesticides for sustainable agricultural and horticultural production. In many parts of the world including Europe, fragmented research based on short-term funding has been unable to answer to the needs to develop sustainable long-term solutions to crop protection, while colleagues in China have been successful in implementing programs that exemplify the power of the ecostacking approach. Key contributions by European and US specialists combined with the expertise and experiences by the Chinese contributors comprise the building blocks for the integration of biological control approaches into the overall frame of ecostacking. This book will lead the way to a broader, integrated adoption of biological control techniques in sustainable pest, disease and weed management supporting also the functioning of other key ecosystem services. Chapter 2 of this book isavailable open access under a CC BY 4.0 license at link.springer.com
Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy
Download or read book Prospects for Biological Control of Plant Feeding Mites and Other Harmful Organisms written by Daniel Carrillo and published by Springer. This book was released on 2015-04-30 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of biological control of harmful organisms by mites is marked by outstanding achievements with a few premiere natural enemies. Early works concentrated on the use of predatory mites for the control of synanthropic flies, More recently, the focus has been mostly on mites of the family Phytoseiidae for the control of plant feeding mites. This is an important family of acarine predators of plant pest mites, which are effectively used in agriculture worldwide. Besides the vast knowledge in several species in this family, there are as well many opportunities for biological control, represented in an array of organisms and through the improvement of management techniques, which are constantly explored by researchers worldwide. This has resulted in an increasing interest in predatory mite species within the families Stigmaeidae, Ascidae, Laelapidae, Rhodacaroidea, Macrochelidae, Erythraeidae and Cheyletidae, among others. This book will compile important developments with predatory mite species within these families, which are emerging as important tools for integrated pest management. New developments with predatory insects and pathogenic organisms attacking mites will also be a subject of this book. Finally, the potential and gaps in knowledge in biological control of acarine plant pests will be addressed.
Download or read book Biological Management of Diseases of Crops written by P. Narayanasamy and published by Springer Science & Business Media. This book was released on 2013-06-28 with total page 691 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological disease management tactics have emerged as potential alternative to chemical application for containing crop diseases. Biotic and abiotic biological control agents (BCAs) have been demonstrated to be effective against diseases caused by microbial plant pathogens. Combination of biotic and abiotic agents leads to synergism and consequent improvement in the effectiveness of disease control. It is essential to assay the biocontrol potential of all isolates/species of fungal, bacterial and viral biocontrol agents by different techniques in vitro and under greenhouse and field conditions and to precisely identify and differentiate the most effective isolates from less effective ones by employing biological, immunological and nucleic acid-based assays.
Download or read book Biosafety in the Laboratory written by Division on Engineering and Physical Sciences and published by National Academies Press. This book was released on 1989-01-01 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safetyâ€"and more.
Download or read book Trophic and Guild Interactions in Biological Control written by Jacques Brodeur and published by Springer Science & Business Media. This book was released on 2007-06-03 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores modern concepts of trophic and guild interactions among natural enemies in natural and agricultural ecosystems - a field that has become a hot topic in ecology and biological control over the past decade. It is the first book on trophic and guild interactions to make the link to biological control, and is compiled by internationally recognized scientists who have combined their expertise.
