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 Biological Collections written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2021-01-29 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological collections are a critical part of the nation's science and innovation infrastructure and a fundamental resource for understanding the natural world. Biological collections underpin basic science discoveries as well as deepen our understanding of many challenges such as global change, biodiversity loss, sustainable food production, ecosystem conservation, and improving human health and security. They are important resources for education, both in formal training for the science and technology workforce, and in informal learning through schools, citizen science programs, and adult learning. However, the sustainability of biological collections is under threat. Without enhanced strategic leadership and investments in their infrastructure and growth many biological collections could be lost. Biological Collections: Ensuring Critical Research and Education for the 21st Century recommends approaches for biological collections to develop long-term financial sustainability, advance digitization, recruit and support a diverse workforce, and upgrade and maintain a robust physical infrastructure in order to continue serving science and society. The aim of the report is to stimulate a national discussion regarding the goals and strategies needed to ensure that U.S. biological collections not only thrive but continue to grow throughout the 21st century and beyond.

Download or read book Biologics A History of Agents Made From Living Organisms in the Twentieth Century written by Alexander von Schwerin and published by Routledge. This book was released on 2015-10-06 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of biologics – drugs made from living organisms – has raised specific scientific, industrial, medical and legal issues. The essays contained in this collection each deal with a case study of a biologic substance, or group of biologics, and its use during the twentieth century.

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 2022-09-30 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 75th meeting of the WHO Expert Committee on Biological Standardization was held from 4 to 8 April 2022 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvao Simão, Assistant Director-General, Access to Medicines and Health Products. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, developers of vaccines and other biological products and academia.

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 Biological Autonomy written by Alvaro Moreno and published by Springer. This book was released on 2015-05-04 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since Darwin, Biology has been framed on the idea of evolution by natural selection, which has profoundly influenced the scientific and philosophical comprehension of biological phenomena and of our place in Nature. This book argues that contemporary biology should progress towards and revolve around an even more fundamental idea, that of autonomy. Biological autonomy describes living organisms as organised systems, which are able to self-produce and self-maintain as integrated entities, to establish their own goals and norms, and to promote the conditions of their existence through their interactions with the environment. Topics covered in this book include organisation and biological emergence, organisms, agency, levels of autonomy, cognition, and a look at the historical dimension of autonomy. The current development of scientific investigations on autonomous organisation calls for a theoretical and philosophical analysis. This can contribute to the elaboration of an original understanding of life - including human life - on Earth, opening new perspectives and enabling fecund interactions with other existing theories and approaches. This book takes up the challenge.

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 2014 with total page 507 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. 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 of revised WHO Recommendations and Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included the development of WHO guidance on the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated); recombinant malaria vaccines; diphtheria vaccines (adsorbed); tetanus vaccines (adsorbed); combined vaccines based on diphtheria and tetanus vaccines; and Japanese encephalitis vaccines (live, attenuated). Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of vaccines and related substances; blood products and related substances; in vitro diagnostic device reagents; biotherapeutics other than blood products; and antibiotics. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2-7). All additions made during the meeting to the list of International Standards and Reference Reagents for biological substances maintained by WHO are then summarized in Annex 8.

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 Baseless written by Nicholson Baker and published by Penguin. This book was released on 2020-07-21 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Staggeringly good.” —Counterpunch A major new work, a hybrid of history, journalism, and memoir, about the modern Freedom of Information Act—FOIA—and the horrifying, decades-old government misdeeds that it is unable to demystify, from one of America's most celebrated writers Eight years ago, while investigating the possibility that the United States had used biological weapons in the Korean War, Nicholson Baker requested a series of Air Force documents from the early 1950s under the provisions of the Freedom of Information Act. Years went by, and he got no response. Rather than wait forever, Baker set out to keep a personal journal of what it feels like to try to write about major historical events in a world of pervasive redactions, witheld records, and glacially slow governmental responses. The result is one of the most original and daring works of nonfiction in recent memory, a singular and mesmerizing narrative that tunnels into the history of some of the darkest and most shameful plans and projects of the CIA, the Air Force, and the presidencies of Harry Truman and Dwight Eisenhower. In his lucid and unassuming style, Baker assembles what he learns, piece by piece, about Project Baseless, a crash Pentagon program begun in the early fifties that aimed to achieve "an Air Force-wide combat capability in biological and chemical warfare at the earliest possible date." Along the way, he unearths stories of balloons carrying crop disease, leaflet bombs filled with feathers, suicidal scientists, leaky centrifuges, paranoid political-warfare tacticians, insane experiments on animals and humans, weaponized ticks, ferocious propaganda battles with China, and cover and deception plans meant to trick the Kremlin into ramping up its germ-warfare program. At the same time, Baker tells the stories of the heroic journalists and lawyers who have devoted their energies to wresting documentary evidence from government repositories, and he shares anecdotes from his daily life in Maine feeding his dogs and watching the morning light gather on the horizon. The result is an astonishing and utterly disarming story about waiting, bureaucracy, the horrors of war, and, above all, the cruel secrets that the United States government seems determined to keep forever from its citizens.

Download or read book A History of Therapeutic Goods Regulation in Australia written by John McEwan and published by . This book was released on 2007 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Species Concepts in Biology written by Frank E. Zachos and published by Springer. This book was released on 2016-10-05 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Frank E. Zachos offers a comprehensive review of one of today’s most important and contentious issues in biology: the species problem. After setting the stage with key background information on the topic, the book provides a brief history of species concepts from antiquity to the Modern Synthesis, followed by a discussion of the ontological status of species with a focus on the individuality thesis and potential means of reconciling it with other philosophical approaches. More than 30 different species concepts found in the literature are presented in an annotated list, and the most important ones, including the Biological, Genetic, Evolutionary and different versions of the Phylogenetic Species Concept, are discussed in more detail. Specific questions addressed include the problem of asexual and prokaryotic species, intraspecific categories like subspecies and Evolutionarily Significant Units, and a potential solution to the species problem based on a hierarchical approach that distinguishes between ontological and operational species concepts. A full chapter is dedicated to the challenge of delimiting species by means of a discrete taxonomy in a continuous world of inherently fuzzy boundaries. Further, the book outlines the practical ramifications for ecology and evolutionary biology of how we define the species category, highlighting the danger of an apples and oranges problem if what we subsume under the same name (“species”) is in actuality a variety of different entities. A succinct summary chapter, glossary and annotated list of references round out the coverage, making the book essential reading for all biologists looking for an accessible introduction to the historical, philosophical and practical dimensions of the species problem.

Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

Download or read book Rethinking Health Care Ethics written by Stephen Scher and published by Springer. This book was released on 2018-08-02 with total page 177 pages. Available in PDF, EPUB and Kindle. Book excerpt: ​The goal of this open access book is to develop an approach to clinical health care ethics that is more accessible to, and usable by, health professionals than the now-dominant approaches that focus, for example, on the application of ethical principles. The book elaborates the view that health professionals have the emotional and intellectual resources to discuss and address ethical issues in clinical health care without needing to rely on the expertise of bioethicists. The early chapters review the history of bioethics and explain how academics from outside health care came to dominate the field of health care ethics, both in professional schools and in clinical health care. The middle chapters elaborate a series of concepts, drawn from philosophy and the social sciences, that set the stage for developing a framework that builds upon the individual moral experience of health professionals, that explains the discontinuities between the demands of bioethics and the experience and perceptions of health professionals, and that enables the articulation of a full theory of clinical ethics with clinicians themselves as the foundation. Against that background, the first of three chapters on professional education presents a general framework for teaching clinical ethics; the second discusses how to integrate ethics into formal health care curricula; and the third addresses the opportunities for teaching available in clinical settings. The final chapter, "Empowering Clinicians", brings together the various dimensions of the argument and anticipates potential questions about the framework developed in earlier chapters.

Download or read book Regenesis written by George M Church and published by Basic Books. This book was released on 2014-04-08 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Harvard biologist and master inventor explores how new biotechnologies will enable us to bring species back from the dead, unlock vast supplies of renewable energy, and extend human life. In Regenesis, George Church and science writer Ed Regis explore the possibilities of the emerging field of synthetic biology. Synthetic biology, in which living organisms are selectively altered by modifying substantial portions of their genomes, allows for the creation of entirely new species of organisms. These technologies-far from the out-of-control nightmare depicted in science fiction-have the power to improve human and animal health, increase our intelligence, enhance our memory, and even extend our life span. A breathtaking look at the potential of this world-changing technology, Regenesis is nothing less than a guide to the future of life.

Download or read book Measures for Progress written by Rexmond Canning Cochrane and published by . This book was released on 1966 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Immortal Life of Henrietta Lacks written by Rebecca Skloot and published by Crown. This book was released on 2010-02-02 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: #1 NEW YORK TIMES BESTSELLER • “The story of modern medicine and bioethics—and, indeed, race relations—is refracted beautifully, and movingly.”—Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE • ONE OF THE “MOST INFLUENTIAL” (CNN), “DEFINING” (LITHUB), AND “BEST” (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE • ONE OF ESSENCE’S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS • WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • Entertainment Weekly • O: The Oprah Magazine • NPR • Financial Times • New York • Independent (U.K.) • Times (U.K.) • Publishers Weekly • Library Journal • Kirkus Reviews • Booklist • Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells—taken without her knowledge—became one of the most important tools in medicine: The first “immortal” human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb’s effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta’s family did not learn of her “immortality” until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family—past and present—is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family—especially Henrietta’s daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn’t her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences.

Download or read book Measuring and Monitoring Biological Diversity written by Ronald Heyer and published by Smithsonian Institution. This book was released on 2014-12-16 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: Measuring and Monitoring Biological Diversity is the first book to provide comprehensive coverage of standard methods for biodiversity sampling of amphibians, with information on analyzing and using data that will interest biologists in general. In this manual, nearly fifty herpetologists recommend ten standard sampling procedures for measuring and monitoring amphibian and many other populations. The contributors discuss each procedure, along with the circumstances for its appropriate use. In addition, they provide a detailed protocol for each procedure's implementation, a list of necessary equipment and personnel, and suggestions for analyzing the data. The data obtained using these standard methods are comparable across sites and through time and, as a result, are extremely useful for making decisions about habitat protection, sustained use, and restoration—decisions that are particularly relevant for threatened amphibian populations.