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Author: World Health Organization Publisher: World Health Organization ISBN: 9241547537 Category : Business & Economics Languages : en Pages : 219
Book Description
This fourth edition of the anthrax guidelines encompasses a systematic review of the extensive new scientific literature and relevant publications up to end 2007 including all the new information that emerged in the 3-4 years after the anthrax letter events. This updated edition provides information on the disease and its importance, its etiology and ecology, and offers guidance on the detection, diagnostic, epidemiology, disinfection and decontamination, treatment and prophylaxis procedures, as well as control and surveillance processes for anthrax in humans and animals. With two rounds of a rigorous peer-review process, it is a relevant source of information for the management of anthrax in humans and animals.
Author: World Health Organization Publisher: World Health Organization ISBN: 9241547537 Category : Business & Economics Languages : en Pages : 219
Book Description
This fourth edition of the anthrax guidelines encompasses a systematic review of the extensive new scientific literature and relevant publications up to end 2007 including all the new information that emerged in the 3-4 years after the anthrax letter events. This updated edition provides information on the disease and its importance, its etiology and ecology, and offers guidance on the detection, diagnostic, epidemiology, disinfection and decontamination, treatment and prophylaxis procedures, as well as control and surveillance processes for anthrax in humans and animals. With two rounds of a rigorous peer-review process, it is a relevant source of information for the management of anthrax in humans and animals.
Author: Jürgen Meier Publisher: Kluwer Law International B.V. ISBN: 9403510803 Category : Law Languages : en Pages : 516
Book Description
Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have come to dominate the ranks of blockbuster drugs, currently accounting for 10 out of the top 15 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, most notably Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which have severely curtailed the possibilities to obtain broad antibody patents. It is therefore essential to understand how antibody inventions are assessed in different jurisdictions in order to secure an optimal patent protection and to successfully enforce such patents. This book provides practitioners with a comprehensive resource elucidating all aspects of the patenting of antibodies from initial drafting and prosecution to enforcement, using a country-by-country format. It covers 23 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland, the United Kingdom, Israel, the United States of America, Argentina, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Brazil, Canada, Chile, Mexico, China, India, Japan, Singapore, South Korea, and Australia. The 35 contributors to this book, all distinguished experts in this field, provide clear and practice-oriented advice on a range of topics including: – Which types of antibody inventions are patent-eligible? – Which types of functional and structural features are accepted for claiming antibodies? – What needs to be considered when defining antibodies in terms of their antigen, target affinity, binding specificity, epitope, competitive binding and other characteristics in relation to reference antibodies, as well as their effects on the target? – Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits? – Which breadth of claims is accepted for antibody inventions, and what experimental support is required? – Which specific medical applications of antibodies can be claimed? – How is inventive step assessed in the specific case of antibody inventions? – What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence? All chapters follow the same structure, which makes this book easily accessible and allows a direct comparison between different jurisdictions. Practitioners will find the much-needed tools and guidance to secure the best possible patent protection for antibody inventions in 23 of the most important jurisdictions worldwide. This book is the fifth volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated, non-profit organization dedicated to improving and promoting the protection of intellectual property at both national and international levels.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309219396 Category : Science Languages : en Pages : 570
Book Description
Many potential applications of synthetic and systems biology are relevant to the challenges associated with the detection, surveillance, and responses to emerging and re-emerging infectious diseases. On March 14 and 15, 2011, the Institute of Medicine's (IOM's) Forum on Microbial Threats convened a public workshop in Washington, DC, to explore the current state of the science of synthetic biology, including its dependency on systems biology; discussed the different approaches that scientists are taking to engineer, or reengineer, biological systems; and discussed how the tools and approaches of synthetic and systems biology were being applied to mitigate the risks associated with emerging infectious diseases. The Science and Applications of Synthetic and Systems Biology is organized into sections as a topic-by-topic distillation of the presentations and discussions that took place at the workshop. Its purpose is to present information from relevant experience, to delineate a range of pivotal issues and their respective challenges, and to offer differing perspectives on the topic as discussed and described by the workshop participants. This report also includes a collection of individually authored papers and commentary.
Author: Annette M. Doherty Publisher: Elsevier ISBN: 0080471978 Category : Science Languages : en Pages : 447
Book Description
Annual Reports in Medicinal Chemistry continues to focus on providing timely and critical reviews of important topics in medicinal chemistry together with an emphasis on emerging topics in the biological sciences, which are expected to provide the basis for entirely new future therapies. Sections I-IV are disease orientated and generally report on specific medicinal agents. Sections V and VI continue to emphasize important topics in medicinal chemistry, biology, and drug design. - Annual comprehensive reviews of the past year literature in many topics of interest to medicinal chemists - Includes a comprehensive set of indices to easily locate topics in Volumes 1-38 of this series - Provides critical review on hot topics in medicinal chemistry
Author: Feroz Jameel Publisher: Springer ISBN: 9783030314170 Category : Medical Languages : en Pages : 893
Book Description
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
Author: Robert Gordon Wasson Publisher: Houghton Mifflin Harcourt P ISBN: Category : History Languages : en Pages : 156
Book Description
"Presented here is an astonishing solution to the Mysteries of Eleusis, the secret religious rites of ancient Greece that have remained a riddle for the Western World for close to 4,000 years. Acting on an insight into the true nature of the rites, R. Gordon Wasson sought the collaboration of Albert Hoffman, the renowned chemist who discovered LSD, and Carl A. P. Ruck, a classical scholar specializing in Greek ethnobotany. Wasson, the author of three books on the role of hallucinogenic mushrooms in human societies, has already uncovered the mushroom cult of Mesoamerica and identified the elusive "Soma" of the Vedic hymns. Closely coordinating their research, the three scholar-scientists first offered documentation on the religious rites at an International Conference on Hallucinogenic Mushrooms in late 1977. These sensational findings, given here in a much expanded version, leave little doubt that the ancient secret of Eleusis has at last been unveiled."--Pg. [4] of cover.
Author: David Green Publisher: Academic Press ISBN: 0128129557 Category : Science Languages : en Pages : 286
Book Description
Hemophilia and Von Willebrand Disease: Factor VIII and Von Willebrand Factor serves as a must-have reference on the important role these essential blood-clotting proteins play in research and clinical medicine. Clinicians and researchers face the daily challenge of staying current on the vast amounts of research that is now generated. The reference to Janus in the title refers to the two roles of the Factor VIII/Von Willebrand Factor Complex: initiation of coagulation and propagation of clot formation. The complex prevents bleeding in hemophilia and Von Willebrand disease but also augments arterial and venous thrombosis. - Presents one source of information on Hemophilia and Von Willebrand Disease, as well as Factor VIII and Von Willebrand Factor, eliminating the search through hundreds of journal articles - Combines the multi-disciplinary research that is generated from Factor VIII/Von Willebrand Factor – hematology, drug discovery, genetics, cell biology, and oncology - Delves into unanswered questions and future directions of this important blood-clotting complex
Author: World Health Organization
Author: World Health Organization
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Author: Jürgen Meier
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Author: Institute of Medicine
Author: Annette M. Doherty
Author: Feroz Jameel
Author: Robert Gordon Wasson
Author: David Green