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EBookClubs

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Book International Symposium on Pyrogenicity  Innocuity and Toxicity Test Systems for Biological Products

Download or read book International Symposium on Pyrogenicity Innocuity and Toxicity Test Systems for Biological Products written by International Symposium on Pyrogenicity, Innocuity and Toxicity Test Systems for Biological Products 1976, Budapest and published by . This book was released on 1977 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book WHO Expert Committee on Biological Standardization

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.

Book WHO Expert Committee on Biological Standardization

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 2002 with total page 104 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 quality 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 issues relevant to international guidelines recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy various antigens blood products cytokines growth factors and endocrinological substances. The second part of the report of particular interest to manufacturers and national control authorities contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine and other relevant documents.

Book Essential Clinical Immunology

Download or read book Essential Clinical Immunology written by John B. Zabriskie and published by Cambridge University Press. This book was released on 2009-01-12 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ways in which we can better understand cancer, HIV, and other autoimmune diseases through clinical immunology are of great interest to practitioners from the student level to the advanced PhD. Designed as an introduction for practitioners and residents. This book focuses on the clinical disease-state level of immunology, beginning with the basic concepts and then detailing the immunological aspects of various disease states involving major organs of the body. It explores how we can better understand disease and its treatment through clinical immunology; each chapter concludes with patterns for future research.

Book Medical Device Design

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Book Chemistry and Technology of the Cosmetics and Toiletries Industry

Download or read book Chemistry and Technology of the Cosmetics and Toiletries Industry written by S.D. Williams and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition has been designed to monitor the progress in develop ment over the past few years and to build on the information given in the first edition. It has been extensively revised and updated. My thanks go to all who have contributed to this work. D.F.W. May 1996 Preface to the first edition This book is the result of a group of development scientists feeling that there was an urgent need for a reference work that would assist chemists in understanding the science involved in the development of new products. The approach is to inform in a way that allows and encourages the reader to develop his or her own creativity in working with marketing colleagues on the introduction of new products. Organised on a product category basis, emphasis is placed on formulation, selection of raw materials, and the technology of producing the products discussed. Performance considerations, safety, product liability and all aspects of quality are covered. Regulations governing the production and sale of cosmetic products internationally are described, and sources for updated information provided. Throughout the book, reference is made to consumer pressure and environmental issues-concerns which the development scientist and his or her marketing counterpart ignore at their own, and their employer's peril. In recent years, many cosmetic fragrances and toiletry products have been converted from aerosols to mechanically press uri sed products or sprays, and these are described along with foam products such as hair conditioning mousses.

Book Biocompatibility and Performance of Medical Devices

Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

Book Applied Mineralogy of Cement   Concrete

Download or read book Applied Mineralogy of Cement Concrete written by Maarten A.T.M. Broekmans and published by Walter de Gruyter GmbH & Co KG. This book was released on 2018-12-17 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume 74 of Reviews in Mineralogy and Geochemistry contains a selection of papers on the applied mineralogy of cement and concrete, by far the most popular modern building material by volume, with an annual production exceeding 9 billion cubic meters, and steadily growing. Not even all 'concrete' topics can be covered by a single volume, but an interesting assortment was finally obtained. The seven chapters deal with mineralogy and chemistry of (alumina) clinker production and hydration (Pöllmann), alternative raw clinkering materials to reduce CO2 emission (Justnes), assessment of clinker constituents by optical and electron microscopy (Stutzman), industrial assessment of raw materials, cement and concrete using X-ray methods in different applications (Meier et al.), in situ investigation of clinker and cement hydration based on quantitative crystallographic phase analysis (Aranda et al.), characterization and properties of supplementary cementitious materials (SCMs) to improve cement and concrete properties (Snellings et al.), and deleterious alkali-aggregate reaction (AAR) in concrete (Broekmans).

Book Current Trends in Cryobiology

Download or read book Current Trends in Cryobiology written by Audrey U. Smith and published by Springer. This book was released on 2013-11-11 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past 20 years there have been amazing developments in low temperature physics, engineering, and biology. They form part of the very rapid post-war growth in pure and applied sciences of every kind. During this period several branches of biology including immunology, molecular biology and, of course, cryobiology, have split off from their parent disciplines. One result of this splintering has been the development of separate jargons used by the specialists and sometimes incomprehensible to those working in closely allied fields. The pure physicists, chemists, and the applied scientists, including physicians, surgeons, and pathologists, find the new jargons particularly baffling. We have attempted in this monograph to present to cryogenic engineers a picture of cryobiologists and their problems using as few strange technical words as possible. We hope that this book will help to bridge the gap which has already formed between them in spite of the opportunities for collaboration in many projects. We hope that it may also be useful to scientific research workers and postgraduate students of many kinds united only by curiosity about cryobiology. We are very much indebted to Dr. K. Mendelssohn, who insti gated us to produce a monograph and who reassured us that cryogenic engineers are as keen to understand the current trends in biology, and particularly in cryobiology, as we are to enlist their help. We have had much help in preparing this book.

Book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.

Book Theriogenology in Camelidae

Download or read book Theriogenology in Camelidae written by Ahmed Tibary and published by . This book was released on 1997 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Fractional Processes and Fractional Order Signal Processing

Download or read book Fractional Processes and Fractional Order Signal Processing written by Hu Sheng and published by Springer Science & Business Media. This book was released on 2011-10-20 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fractional processes are widely found in science, technology and engineering systems. In Fractional Processes and Fractional-order Signal Processing, some complex random signals, characterized by the presence of a heavy-tailed distribution or non-negligible dependence between distant observations (local and long memory), are introduced and examined from the ‘fractional’ perspective using simulation, fractional-order modeling and filtering and realization of fractional-order systems. These fractional-order signal processing (FOSP) techniques are based on fractional calculus, the fractional Fourier transform and fractional lower-order moments. Fractional Processes and Fractional-order Signal Processing: presents fractional processes of fixed, variable and distributed order studied as the output of fractional-order differential systems; introduces FOSP techniques and the fractional signals and fractional systems point of view; details real-world-application examples of FOSP techniques to demonstrate their utility; and provides important background material on Mittag–Leffler functions, the use of numerical inverse Laplace transform algorithms and supporting MATLAB® codes together with a helpful survey of relevant webpages. Readers will be able to use the techniques presented to re-examine their signals and signal-processing methods. This text offers an extended toolbox for complex signals from diverse fields in science and engineering. It will give academic researchers and practitioners a novel insight into the complex random signals characterized by fractional properties, and some powerful tools to analyze those signals.