Download or read book User Protocol for Evaluation of Qualitative Test Performance written by Patricia E. Garrett and published by . This book was released on 2008 with total page 47 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book User protocol for evaluation of qualitative test performance written by Larry W. Clark and published by . This book was released on 2002 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book User protocol for evaluation of qualitative test performance written by Larry W. Clark and published by . This book was released on 2000 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Essentials for verifying test performance accreditation preparedness SCQ02 written by and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Journal of the National Cancer Institute written by and published by . This book was released on 2012 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Immunoassay Handbook written by David Wild and published by Newnes. This book was released on 2013-01-21 with total page 1037 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of The Immunoassay Handbook provides an excellent, thoroughly updated guide to the science, technology and applications of ELISA and other immunoassays, including a wealth of practical advice. It encompasses a wide range of methods and gives an insight into the latest developments and applications in clinical and veterinary practice and in pharmaceutical and life science research. Highly illustrated and clearly written, this award-winning reference work provides an excellent guide to this fast-growing field. Revised and extensively updated, with over 30% new material and 77 chapters, it reveals the underlying common principles and simplifies an abundance of innovation. The Immunoassay Handbook reviews a wide range of topics, now including lateral flow, microsphere multiplex assays, immunohistochemistry, practical ELISA development, assay interferences, pharmaceutical applications, qualitative immunoassays, antibody detection and lab-on-a-chip. This handbook is a must-read for all who use immunoassay as a tool, including clinicians, clinical and veterinary chemists, biochemists, food technologists, environmental scientists, and students and researchers in medicine, immunology and proteomics. It is an essential reference for the immunoassay industry. Provides an excellent revised guide to this commercially highly successful technology in diagnostics and research, from consumer home pregnancy kits to AIDS testing.www.immunoassayhandbook.com is a great resource that we put a lot of effort into. The content is designed to encourage purchases of single chapters or the entire book. David Wild is a healthcare industry veteran, with experience in biotechnology, pharmaceuticals, medical devices and immunodiagnostics, which remains his passion. He worked for Amersham, Eastman-Kodak, Johnson & Johnson, and Bristol-Myers Squibb, and consulted for diagnostics and biotechnology companies. He led research and development programs, design and construction of chemical and biotechnology plants, and integration of acquired companies. Director-level positions included Research and Development, Design Engineering, Operations and Strategy, for billion dollar businesses. He retired from full-time work in 2012 to focus on his role as Editor of The Immunoassay Handbook, and advises on product development, manufacturing and marketing. Provides a unique mix of theory, practical advice and applications, with numerous examples Offers explanations of technologies under development and practical insider tips that are sometimes omitted from scientific papers Includes a comprehensive troubleshooting guide, useful for solving problems and improving assay performancee Provides valuable chapter updates, now available on www.immunoassayhandbook.com
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
Download or read book Clinical Virology Manual written by Richard L. Hodinka and published by John Wiley & Sons. This book was released on 2020-07-10 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive clinical virology resource for physicians and clinical laboratory virologists The clinical virology field is rapidly evolving and, as a result, physicians and clinical laboratory virologists must have a reliable reference tool to aid in their ability to identify and diagnose viral infections to prevent future outbreaks. In this completely revised edition of the Clinical Virology Manual, Editor in Chief, Michael Loeffelholz, along with Section Editors, Richard Hodinka, Benjamin Pinsky, and Stephen Young, have complied expert perspectives of a renowned team of clinical virology experts and divided these contributions into three sections to provide the latest information on the diagnosis of viral infections, including ebola, HIV and Human papillomavirus state of the art diagnostic technologies, including next-generation sequencing and nucleic acid amplification methods taxonomy of clinically important viruses such as polyomaviruses and zoonotic viruses This comprehensive reference also includes three appendices with vital information on reference virology laboratories at the Centers for Disease Control and Prevention, state and local public health laboratories, and international reference laboratories and laboratory systems. Additionally, a new section "Diagnostic Best Practices," which summarizes recommendations for diagnostic testing, and cites evidence-based guidelines, is included in each viral pathogens chapter. Clinical Virology Manual, Fifth Edition serves as a reference source to healthcare professionals and laboratorians in providing clinical and technical information regarding viral diseases and the diagnosis of viral infections.
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
Download or read book Molecular Microbiology written by David H. Persing and published by John Wiley & Sons. This book was released on 2020-07-24 with total page 835 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting the latest molecular diagnostic techniques in one comprehensive volume The molecular diagnostics landscape has changed dramatically since the last edition of Molecular Microbiology: Diagnostic Principles and Practice in 2011. With the spread of molecular testing and the development of new technologies and their opportunities, laboratory professionals and physicians more than ever need a resource to help them navigate this rapidly evolving field. Editors David Persing and Fred Tenover have brought together a team of experienced researchers and diagnosticians to update this third edition comprehensively, to present the latest developments in molecular diagnostics in the support of clinical care and of basic and clinical research, including next-generation sequencing and whole-genome analysis. These updates are provided in an easy-to-read format and supported by a broad range of practical advice, such as determining the appropriate type and quantity of a specimen, releasing and concentrating the targets, and eliminating inhibitors. Molecular Microbiology: Diagnostic Principles and Practice Presents the latest basic scientific theory underlying molecular diagnostics Offers tested and proven applications of molecular diagnostics for the diagnosis of infectious diseases, including point-of-care testing Illustrates and summarizes key concepts and techniques with detailed figures and tables Discusses emerging technologies, including the use of molecular typing methods for real-time tracking of infectious outbreaks and antibiotic resistance Advises on the latest quality control and quality assurance measures Explores the increasing opportunities and capabilities of information technology Molecular Microbiology: Diagnostic Principles and Practice is a textbook for molecular diagnostics courses that can also be used by anyone involved with diagnostic test selection and interpretation. It is also a useful reference for laboratories and as a continuing education resource for physicians.
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/.
Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2013-09-30 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.
Download or read book Drug Development for Gene Therapy written by Yanmei Lu and published by John Wiley & Sons. This book was released on 2024-02-28 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Development for Gene Therapy Industry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. The chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics / lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Written by two highly qualified authors with significant experience in the field, Drug Development for Gene Therapy includes information on: Bioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsids Detection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy products Nonclinical and clinical study considerations and methods for biodistribution and shedding Quantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapy Detection and quantification of rAAV integration and off-target editing Current regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics With comprehensive coverage of the subject, Drug Development for Gene Therapy is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences.
Download or read book Drugs and Laboratory Parameters written by Achille Patrizio Caputi and published by SEEd. This book was released on 2011-02-28 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Even if clinical and laboratory parameters can be considered as predictors for ADRs, the possibility of a drug-related variation of blood tests is seldom taken into consideration. Aim of this easy-to-read book is to help physicians in the routine interpretation of laboratory results, drawing their attention to the possibility that abnormal laboratory results may be drug-related. The book describes the most common variations (increase/decrease) of blood parameters that can be caused by drugs intake. Functions of each blood parameter are schematically reported, together with its standard blood concentration and a list of the most common disease for whose diagnosis that test is performed. Active principles are then listed, that can cause an increase or a decrease of that parameter.
Download or read book Automation and Emerging Technology in Clinical Microbiology An Issue of Clinics in Laboratory Medicine written by Carey-Ann D. Burnham and published by Elsevier Health Sciences. This book was released on 2013-09-28 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of Clinical Microbiology is evolving at a rapid pace, perhaps more so than any other arm of laboratory medicine. This can be attributed to new technology, including high throughput gene sequencing, multiplex molecular assays, rapid evolution of antimicrobial resistance, and discovery of new pathogens. In addition, modern medical procedures, such as solid organ and stem cell transplantation, have resulted in an explosion of infections with agents that historically have been considered to be of low virulence. This issue of Clinics in Laboratory Medicine will highlight some of the advances in diagnostic microbiology, including MALDI-TOF MS, pathogen discovery, and personalized antimicrobial chemotherapy. In addition, one of the papers will focus on implementation of new technologies and how to maximize patient impact of these new methods.
Download or read book Six Sigma and Quality Management written by Paulo Pereira and published by BoD – Books on Demand. This book was released on 2024-03-20 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Six Sigma and Quality Management serves as an indispensable resource for professionals, practitioners, and enthusiasts seeking a clear roadmap for implementing and optimizing Six Sigma and quality management system methodologies. From the fundamental principles of Six Sigma, including the DMAIC approach, to the broader spectrum of quality management, readers will gain practical insights into enhancing processes, reducing variation, and fostering a culture of continuous improvement. The text covers essential topics such as Total Quality Management (TQM), Lean principles, and improvement methodologies, offering actionable tools and techniques to streamline operations and enhance overall efficiency. With a focus on audits, corrective action/preventive action (CAPA) processes, and the intricacies of controlling externally provided processes, products, and services, this book provides a holistic view of quality management practices. In a specialized section, the book explores the unique challenges and stringent requirements for quality and competence in medical laboratories within the healthcare sector. Additionally, it delves into the integration of digital technologies into quality management, known as Quality 4. 0, showcasing the transformative potential of data analytics and artificial intelligence. Real-world examples and practical insights throughout the book make it a valuable resource for both those new to these methodologies and seasoned professionals seeking to refine their approach. This book is a practical and insightful companion for organizations navigating the intricacies of Six Sigma and quality management to achieve excellence in their operations and deliver enhanced value to their stakeholders.
Download or read book Manual of Molecular and Clinical Laboratory Immunology written by Barbara Detrick and published by John Wiley & Sons. This book was released on 2016-05-02 with total page 3144 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE authoritative guide for clinical laboratory immunology For over 40 years the Manual of Molecular and Clinical Laboratory Immunology has served as the premier guide for the clinical immunology laboratory. From basic serology testing to the present wide range of molecular analyses, the Manual has reflected the exponential growth in the field of immunology over the past decades. This eighth edition reflects the latest advances and developments in the diagnosis and treatment of patients with infectious and immune-mediated disorders. The Manual features detailed descriptions of general and specific methodologies, placing special focus on the interpretation of laboratory findings, and covers the immunology of infectious diseases, including specific pathogens, as well as the full range of autoimmune and immunodeficiency diseases, cancer, and transplantation. Written to guide the laboratory director, the Manual will also appeal to other laboratory scientists, especially those working in clinical immunology laboratories, and pathologists. It is also a useful reference for physicians, mid-level providers, medical students, and allied health students with an interest in the role that immunology plays in the clinical laboratory.
