User Protocol for Evaluation of Qualitative Test Performance PDF Download
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Author: Patricia E. Garrett
Publisher:
ISBN: 9781562386542
Category :
Languages : en
Pages : 47
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Book Description
Author: Patricia E. Garrett
Publisher:
ISBN: 9781562386542
Category :
Languages : en
Pages : 47
Get Book Here
Book Description
Author: Shein-Chung Chow
Publisher: John Wiley & Sons
ISBN: 1118458141
Category : Mathematics
Languages : en
Pages : 838
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Book Description
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.
Author: Shigeyuki Matsui
Publisher: CRC Press
ISBN: 1466558164
Category : Mathematics
Languages : en
Pages : 394
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Book Description
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
Author: Ian W.J. Carter
Publisher: Springer Science & Business Media
ISBN: 9048190398
Category : Science
Languages : en
Pages : 420
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Book Description
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
Author: David Wild
Publisher: Newnes
ISBN: 0080970389
Category : Science
Languages : en
Pages : 1037
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Book Description
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
Author: Yanmei Lu
Publisher: John Wiley & Sons
ISBN: 1119852781
Category : Medical
Languages : en
Pages : 500
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Book Description
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.
Author: Richard L. Hodinka
Publisher: John Wiley & Sons
ISBN: 155581915X
Category : Medical
Languages : en
Pages : 639
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Book Description
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.
Author:
Publisher:
ISBN:
Category : Cancer
Languages : en
Pages : 548
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Book Description
Author: Paulo Pereira
Publisher: BoD – Books on Demand
ISBN: 1803567287
Category : Business & Economics
Languages : en
Pages : 224
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Book Description
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.
Author: Shailendra K. Saxena
Publisher: BoD – Books on Demand
ISBN: 953512580X
Category : Medical
Languages : en
Pages : 174
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Book Description
This book gives a comprehensive overview of the recent advancements and developments of rapid diagnostic tests (RDTs) and technologies, which are quite novel approaches and might be used as laboratory bench manual for the rapid diagnosis of the various disease conditions. The book focuses on various aspects and properties of RDTs, point-of-care tests (POCTs), quality control, assurance, calibration, safety, nano-/microfluidic technologies, and fusion with DNA technologies. I hope that this work might increase the interest in this field of research and that the readers will find it useful for their investigations, management, and clinical usage.
