Guidance On Increasing Supplies Of Plasma Derived Medicinal Products In Low And Middle Income Countries Through Fractionation Of Domestic Plasma

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Global status report on blood safety and availability 2021

Author : World Health Organization
Publisher : World Health Organization
Page : 184 pages
File Size : 55,5 Mb
Release : 2022-06-30
Category : Medical
ISBN : 9789240051683

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Global status report on blood safety and availability 2021 by World Health Organization Pdf

Screening Donated Blood for Transfusion-transmissible Infections

Author : World Health Organization
Publisher : World Health Organization
Page : 73 pages
File Size : 40,7 Mb
Release : 2010
Category : Medical
ISBN : 9789241547888

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Screening Donated Blood for Transfusion-transmissible Infections by World Health Organization Pdf

"Blood transfusion is a life-saving intervention that has an essential role in patient management within health care systems. All Member States of the World Health Organization (WHO) endorsed World Health Assembly resolutions WHA28.72 (1) in 1975 and WHA58.13 (2) in 2005. These commit them to the provision of adequate supplies of safe blood and blood products that are accessible to all patients who require transfusion either to save their lives or promote their continuing or improving health." --Preface.

WHO Expert Committee on Biological Standardization

Author : World Health Organization
Publisher : WHO Technical Report
Page : 0 pages
File Size : 43,9 Mb
Release : 2017
Category : Medical
ISBN : 9241210133

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WHO Expert Committee on Biological Standardization by World Health Organization Pdf

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 revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document "Labeling information of inactivated influenza vaccines for use in pregnant women" was also adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; 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 nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.

Science, the Endless Frontier

Author : Vannevar Bush
Publisher : Princeton University Press
Page : 186 pages
File Size : 44,5 Mb
Release : 2021-02-02
Category : Science
ISBN : 9780691201658

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Science, the Endless Frontier by Vannevar Bush Pdf

The classic case for why government must support science—with a new essay by physicist and former congressman Rush Holt on what democracy needs from science today Science, the Endless Frontier is recognized as the landmark argument for the essential role of science in society and government’s responsibility to support scientific endeavors. First issued when Vannevar Bush was the director of the US Office of Scientific Research and Development during the Second World War, this classic remains vital in making the case that scientific progress is necessary to a nation’s health, security, and prosperity. Bush’s vision set the course for US science policy for more than half a century, building the world’s most productive scientific enterprise. Today, amid a changing funding landscape and challenges to science’s very credibility, Science, the Endless Frontier resonates as a powerful reminder that scientific progress and public well-being alike depend on the successful symbiosis between science and government. This timely new edition presents this iconic text alongside a new companion essay from scientist and former congressman Rush Holt, who offers a brief introduction and consideration of what society needs most from science now. Reflecting on the report’s legacy and relevance along with its limitations, Holt contends that the public’s ability to cope with today’s issues—such as public health, the changing climate and environment, and challenging technologies in modern society—requires a more capacious understanding of what science can contribute. Holt considers how scientists should think of their obligation to society and what the public should demand from science, and he calls for a renewed understanding of science’s value for democracy and society at large. A touchstone for concerned citizens, scientists, and policymakers, Science, the Endless Frontier endures as a passionate articulation of the power and potential of science.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
Publisher : National Academies Press
Page : 69 pages
File Size : 49,9 Mb
Release : 2019-04-05
Category : Medical
ISBN : 9780309487818

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Continuous Manufacturing for the Modernization of Pharmaceutical Production by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology Pdf

On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

Biofuel Co-products as Livestock Feed

Author : Harinder P. S. Makkar
Publisher : Food & Agriculture Organization of the UN (FAO)
Page : 556 pages
File Size : 54,7 Mb
Release : 2012
Category : Agriculture and energy
ISBN : UIUC:30112110382204

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Biofuel Co-products as Livestock Feed by Harinder P. S. Makkar Pdf

This publication covers a wide array of co-products.

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Author : World Health Organization
Publisher : WHO Technical Report
Page : 0 pages
File Size : 44,5 Mb
Release : 2018
Category : Medical
ISBN : 9241210192

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WHO Expert Committee on Specifications for Pharmaceutical Preparations by World Health Organization Pdf

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: - WHO guidelines on good herbal processing practices for herbal medicines; - Guidelines on good manufacturing practices for the manufacture of herbal medicines; - Considerations for requesting analysis of medicine samples; - WHO model certificate of analysis; - WHO guidance on testing of "suspect" falsified medicines; - Good pharmacopoeial practices - Chapter on monographs for compounded preparations; - Good pharmacopoeial practices - Chapter on monographs on herbal medicines; - Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products; - Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions; - Stability testing of active pharmaceutical ingredients and finished pharmaceutical products; and - Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.

Dietary reference values for energy

Author : Scientific Advisory Committee on Nutrition
Publisher : The Stationery Office
Page : 232 pages
File Size : 45,7 Mb
Release : 2012-05-02
Category : Business & Economics
ISBN : 0108511375

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Dietary reference values for energy by Scientific Advisory Committee on Nutrition Pdf

Dietary reference values (DRVs) for energy are based on estimating the total energy expenditure (TEE) for groups of people. TEE provides a measure of the energy requirement at energy balance i.e. when energy intake matches energy expenditure. The methodology to measure TEE - the doubly labelled water (DLW) method - has advanced and as a result, the evidence base on TEE in a wide variety of population groups has expanded considerably. With the high levels of overweight and obesity currently seen in the UK and the wealth of new data now available, it was considered timely for the Scientific Advisory Committee on Nutrition (SACN) to review recommendations for the UK population. This report details the evidence and approaches SACN have considered in order to update the DRVs for energy. SACN chose a prescriptive approach to estimating energy reference values; suitable reference body weight ranges consistent with long-term good health were used to calculate energy reference values. Thus, basal metabolic rate (BMR) values were predicted using healthy reference body weights. Using this approach, if overweight groups consume the amount of energy recommended for healthy weight groups, they are likely to lose weight, whereas underweight sections of the population should gain weight towards the healthy body weight range. SACN has derived new energy reference values. For most population groups, except for infants and young children, the values have increased. DRVs should be used to assess the energy requirements for large groups of people and populations, but should not be applied to individuals due to the large variation in physical activity and energy expenditure observed between people.

Oral Health in America

Author : Anonim
Publisher : Unknown
Page : 32 pages
File Size : 43,5 Mb
Release : 2000
Category : Dental public health
ISBN : UOM:39015043709578

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Oral Health in America by Anonim Pdf