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Evaluation Of Stability Of In Vitro Diagnostic Reagents
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Book Synopsis In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA by : World Health Organization
Download or read book In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA written by World Health Organization and published by World Health Organization. This book was released on 2023-03-06 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid by : World Health Organization
Download or read book In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid written by World Health Organization and published by World Health Organization. This book was released on 2023-10-02 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid by : World Health Organization
Download or read book In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid written by World Health Organization and published by World Health Organization. This book was released on 2023-03-06 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis WHO Expert Committee on Specifications for Pharmaceutical Preparations by : World Health Organization
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2022-12-22 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
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 2018-07-18 with total page 400 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 Ebola vaccines and WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products were adopted on the recommendation of the Committee. In addition the following two WHO guidance documents on the WHO prequalification of in vitro diagnostic medical devices were also adopted: (a) Technical Specifications Series (TSS) for WHO Prequalification - Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing; and (b) Technical Guidance Series (TGS) for WHO Prequalification - Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. 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; 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 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 2017 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 catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Book Synopsis In vitro diagnostic medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid by : World Health Organization
Download or read book In vitro diagnostic medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid written by World Health Organization and published by World Health Organization. This book was released on 2021-11-30 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis In vitro diagnostic medical devices for monitoring of blood glucose in capillary blood by : World Health Organization
Download or read book In vitro diagnostic medical devices for monitoring of blood glucose in capillary blood written by World Health Organization and published by World Health Organization. This book was released on 2023-11-23 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Tietz Textbook of Clinical Chemistry and Molecular Diagnostics - E-Book by : Nader Rifai
Download or read book Tietz Textbook of Clinical Chemistry and Molecular Diagnostics - E-Book written by Nader Rifai and published by Elsevier Health Sciences. This book was released on 2017-01-16 with total page 4785 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th Edition provides the most current and authoritative guidance on selecting, performing, and evaluating the results of new and established laboratory tests. This classic clinical chemistry reference offers encyclopedic coverage detailing everything you need to know, including: analytical criteria for the medical usefulness of laboratory tests, variables that affect tests and results, laboratory medicine, applications of statistical methods, and most importantly clinical utility and interpretation of laboratory tests. It is THE definitive reference in clinical chemistry and molecular diagnostics, now fully searchable and with quarterly content updates, podcasts, clinical cases, animations, and extended content online through Expert Consult. - Analytical criteria focus on the medical usefulness of laboratory procedures. - Reference ranges show new approaches for establishing these ranges — and provide the latest information on this topic. - Lab management and costs gives students and chemists the practical information they need to assess costs, allowing them to do their job more efficiently and effectively. - Statistical methods coverage provides you with information critical to the practice of clinical chemistry. - Internationally recognized chapter authors are considered among the best in their field. - Two-color design highlights important features, illustrations, and content to help you find information easier and faster. - NEW! Internationally recognized chapter authors are considered among the best in their field. - NEW! Expert Consult features fully searchable text, quarterly content updates, clinical case studies, animations, podcasts, atlases, biochemical calculations, multiple-choice questions, links to Medline, an image collection, and audio interviews. You will now enjoy an online version making utility of this book even greater. - UPDATED! Expanded Molecular Diagnostics section with 12 chapters that focus on emerging issues and techniques in the rapidly evolving and important field of molecular diagnostics and genetics ensures this text is on the cutting edge and of the most value. - NEW! Comprehensive list of Reference Intervals for children and adults with graphic displays developed using contemporary instrumentation. - NEW! Standard and international units of measure make this text appropriate for any user — anywhere in the world. - NEW! 22 new chapters that focus on applications of mass spectrometry, hematology, transfusion medicine, microbiology, biobanking, biomarker utility in the pharmaceutical industry and more! - NEW! Expert senior editors, Nader Rifai, Carl Wittwer and Rita Horvath, bring fresh perspectives and help ensure the most current information is presented. - UPDATED! Thoroughly revised and peer-reviewed chapters provide you with the most current information possible.
Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance by : World Health Organization
Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance written by World Health Organization and published by World Health Organization. This book was released on 2024-10-24 with total page 1788 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.
Book Synopsis Tietz Textbook of Laboratory Medicine - E-Book by : Nader Rifai
Download or read book Tietz Textbook of Laboratory Medicine - E-Book written by Nader Rifai and published by Elsevier Health Sciences. This book was released on 2022-02-03 with total page 4232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Use THE definitive reference for laboratory medicine and clinical pathology! Tietz Textbook of Laboratory Medicine, 7th Edition provides the guidance necessary to select, perform, and evaluate the results of new and established laboratory tests. Comprehensive coverage includes the latest advances in topics such as clinical chemistry, genetic metabolic disorders, molecular diagnostics, hematology and coagulation, clinical microbiology, transfusion medicine, and clinical immunology. From a team of expert contributors led by Nader Rifai, this reference includes access to wide-ranging online resources on Expert Consult — featuring the comprehensive product with fully searchable text, regular content updates, animations, podcasts, over 1300 clinical case studies, lecture series, and more. - Authoritative, current content helps you perform tests in a cost-effective, timely, and efficient manner; provides expertise in managing clinical laboratory needs; and shows how to be responsive to an ever-changing environment. - Current guidelines help you select, perform, and evaluate the results of new and established laboratory tests. - Expert, internationally recognized chapter authors present guidelines representing different practices and points of view. - Analytical criteria focus on the medical usefulness of laboratory procedures. - Use of standard and international units of measure makes this text appropriate for any user, anywhere in the world. - Elsevier eBooks+ provides the entire text as a fully searchable eBook, and includes animations, podcasts, more than 1300 clinical case studies, over 2500 multiple-choice questions, a lecture series, and more, all included with print purchase. - NEW! 19 additional chapters highlight various specialties throughout laboratory medicine. - NEW! Updated, peer-reviewed content provides the most current information possible. - NEW! The largest-ever compilation of clinical cases in laboratory medicine is included with print purchase on Elsevier eBooks+. - NEW! Over 100 adaptive learning courses included with print purchase on Elsevier eBooks+ offer the opportunity for personalized education.
Book Synopsis Haemoglobin A1c point-of-care analysers for professional use by : World Health Organization
Download or read book Haemoglobin A1c point-of-care analysers for professional use written by World Health Organization and published by World Health Organization. This book was released on 2024-01-29 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Devices and In Vitro Diagnostics by : Christian Baumgartner
Download or read book Medical Devices and In Vitro Diagnostics written by Christian Baumgartner and published by Springer Nature. This book was released on 2023-08-26 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
Book Synopsis Modern Medicine by : Pronobesh Chattopadhyay
Download or read book Modern Medicine written by Pronobesh Chattopadhyay and published by CRC Press. This book was released on 2024-05-02 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern Medicine: Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2 discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). In the rapidly evolving landscape of modern medicine, groundbreaking innovations have emerged that are reshaping the way we approach healthcare. Modern Medicine delves into the cutting-edge realms of medical devices, medical gases, radiopharmaceuticals, and new drug discovery, offering a comprehensive exploration of these transformative fields that are revolutionizing patient care and medical practices. Discover the future of healthcare technology, and uncover the intricate world of biomedical engineering, where state-of-the-art devices seamlessly merge with the human body to monitor, diagnose, and treat ailments Dive deep into the utilization of medical gases for respiratory conditions, pain management, and even novel applications in regenerative medicine Unravel the mysteries of radiopharmaceuticals, a fusion of molecular imaging and therapy that offers unprecedented insights into the inner workings of the human body Embark on a journey through the intricate processes of drug discovery, where groundbreaking research and cutting-edge technologies are yielding therapies that were once deemed impossible Modern Medicine is a must-read for medical professionals, researchers, students, and anyone intrigued by the remarkable intersection of science, technology, and patient well-being. Join us on a journey to the forefront of medical innovation, where the unimaginable becomes reality, and the future of healthcare takes shape before our eyes. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the pharmaceutical and health industries.
Book Synopsis Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine by : World Health Organization
Download or read book Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine written by World Health Organization and published by World Health Organization. This book was released on 2024-10-22 with total page 33 pages. Available in PDF, EPUB and Kindle. Book excerpt: The document is developed for manufacturers who are interested in applying for WHO prequalification assessment, to assist in the compilation of their product dossier. The document summarizes the minimum analytical and clinical performance studies to be conducted for rapid diagnostic tests (RDTs) for the qualitative detection of mycobacterial lipoarabinomannan (LAM) antigen for point of care professional use in urine of HIV positive individuals.
Book Synopsis Cancer diagnostics in solid tumors - from pathology to precision oncology by : Pedro Borralho
Download or read book Cancer diagnostics in solid tumors - from pathology to precision oncology written by Pedro Borralho and published by Frontiers Media SA. This book was released on 2023-04-05 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Design and Analysis of Clinical Trials for Predictive Medicine by : Shigeyuki Matsui
Download or read book Design and Analysis of Clinical Trials for Predictive Medicine written by Shigeyuki Matsui and published by CRC Press. This book was released on 2015-03-19 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming
Book Synopsis PCR for Clinical Microbiology by : Ian W.J. Carter
Download or read book PCR for Clinical Microbiology written by Ian W.J. Carter and published by Springer Science & Business Media. This book was released on 2010-07-03 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Not another textbook, but a valuable tool for doctors and microbiologists wanting to know how to set up a PCR diagnostic microbiology laboratory according to current regulatory standards and perform assays supplied with patient clinical diagnostic criteria and easy to follow protocols. Whether laboratories are using commercial kits or in-house methods developed in their own laboratories or adopted from published methods, all clinical microbiology laboratories need to be able to understand, critically evaluate, perform and interpret these tests according to rigorous and clinically appropriate standards and international guidelines. The cost and effort of development and evaluation of in-house tests is considerable and many laboratories do not have the resources to do so. This compendium is a vehicle to improve and maintain the clinical relevance and high quality of diagnostic PCR. It is a unique collection of; guidelines for PCR laboratory set up and quality control, test selection criteria, methods and detailed step by step protocols for a diagnostic assays in the field of molecular microbiology. The structure of the book provides the PCR fundamentals and describes the clinical aspects and diagnosis of infectious disease. This is followed by protocols divided into; bacteria, virus, fungi and parasites, and susceptibility screens. The inclusion of medical criteria and interpretation adds value to the compendium and benefits clinicians, scientists, researchers and students of clinical diagnostic microbiology