Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2020-05-15 with total page 247 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 Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines; and an Amendment document to the WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) were adopted on the recommendation of the Committee. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics; 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).
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 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 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 2016 with total page 292 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 Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee. 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 four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-5). Finally, all additions and discontinuations made during the 2015 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalog 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 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 Developments in Biological Standardization written by and published by . This book was released on 1991 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization and published by . This book was released on 2012 with total page 244 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 WHO Guidelines for the production, control and regulation of snake antivenom immunoglobulins and also an addendum to the WHO Recommendations for yellow fever vaccine. Also included are a list of recommendations, guidelines and other documents for biological substances uses in medicine, and of international standards and reference reagent for biological substances
Download or read book The Selection and Use of Essential Medicines written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part provides a brief description of the Open Session of the Committee followed by updates on the Model Formulary and the Essential Medicines Library the Priority Medicines Project and current activities in the field of rational use. There are also progress reports on the review of essential medicines for reproductive health and of the New Emergency Health Kit. The second part presents summaries of the Committee's considerations and justifications for the various deletions additions and changes to the Model List. Annexes to the main report include the 14th WHO Model List of Essential Medicines and a list of all items on the Model List sorted according to their 5-level Anatomical Therapeutic Chemical (ATC) classification codes.
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and published by . This book was released on 1950 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Allergens and Allergen Immunotherapy Second Edition written by Richard F. Lockey and published by CRC Press. This book was released on 1998-09-30 with total page 831 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers and clinicians relate their experience with immunotherapy using antigens, which has remained important throughout the enormous advances in immunology over the past 30 years. Among the topics are a historical perspective, outdoor and indoor allergens, venoms, the preparation and administration of extracts, and reactions and other adverse effects. Annotation copyrighted by Book News, Inc., Portland, OR
Download or read book Biological Standardization of Drugs Before 1928 written by Peter Stechl and published by . This book was released on 1969 with total page 662 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Fifth International Meeting of Biological Standardization written by and published by . This book was released on 1960 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Index of NLM Serial Titles written by National Library of Medicine (U.S.) and published by . This book was released on 1979 with total page 1118 pages. Available in PDF, EPUB and Kindle. Book excerpt: A keyword listing of serial titles currently received by the National Library of Medicine.
Download or read book National Library of Medicine Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on with total page 1028 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1993 with total page 1628 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Download or read book Animal Genomics for Animal Health written by Marie-Hélène Pinard and published by Karger Medical and Scientific Publishers. This book was released on 2008-01-01 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: "It includes a review of the state of the art in animal genomics and its applications to animal health. The contributions describe the new tools available, such as HapMaps for chicken and cattle, and show how the understanding of gene structure and function can be successfully applied to delineate the molecular mechanisms of disease and determine complex phenotypes associated with health traits. A critical evaluation of future needs and future applications of animal genomics is also presented. The integration of animal genomics in animal health research is likely to revolutionize the way scientists approach the challenges of discovering highly effective drugs and vaccines for animal diseases."--BOOK JACKET.
Download or read book Evaluating and Standardizing Therapeutic Agents 1890 1950 written by C. Gradmann and published by Springer. This book was released on 2010-04-08 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the testing of therapeutic sera, the quantified evaluation of a pharmaceutical's efficacy became a key feature of medicine in the twentieth century. The case studies in this volume offer comparisons across Europe, from the diphtheria antitoxin in the late 1800s to the introduction of the Salk polio vaccine in the 1950s.
