Download or read book Evaluation of the Linearity of Quantitative Measurement Procedures written by Daniel W. Tholen and published by . This book was released on 2003 with total page 47 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evaluation of Linearity of Quantitative Measurement Procedures written by and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book EP06 EVALUATION OF LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES written by and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evaluation of Precision of Quantitative Measurement Procedures written by and published by . This book was released on 2014 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This document provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures."--cover. CLSI document: EP05-A3.
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 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 Tietz Textbook of Clinical Chemistry and Molecular Diagnostics written by Nader Rifai and published by Elsevier Health Sciences. This book was released on 2017-01-16 with total page 1888 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.
Download or read book Trace Environmental Quantitative Analysis written by Paul R. Loconto and published by CRC Press. This book was released on 2020-12-27 with total page 767 pages. Available in PDF, EPUB and Kindle. Book excerpt: An introduction to the importance of trace environmental quantitative analysis. Fundamental principles are introduced for the more significant experimental approaches to sample preparation. Principles of instrumental analysis (determinative techniques) for trace organics and trace inorganics analysis. Fundamental principles of measurement and environmental sampling. An introduction to the statistical treatment of trace analytical data. How to calculate instrument detection limits based on weighted least squares confidence band calibration statistics. Includes an updated series of student-tested experiments.
Download or read book Tietz Textbook of Clinical Chemistry and Molecular Diagnostics E Book written by Carl A. Burtis and published by Elsevier Health Sciences. This book was released on 2011-12-16 with total page 2259 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the definitive reference for clinical chemistry, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th Edition offers the most current and authoritative guidance on selecting, performing, and evaluating results of new and established laboratory tests. Up-to-date encyclopedic coverage details everything you need to know, including: analytical criteria for the medical usefulness of laboratory procedures; new approaches for establishing reference ranges; variables that affect tests and results; the impact of modern analytical tools on lab management and costs; and applications of statistical methods. In addition to updated content throughout, this two-color edition also features a new chapter on hemostasis and the latest advances in molecular diagnostics. Section on Molecular Diagnostics and Genetics contains nine expanded chapters that focus on emerging issues and techniques, written by experts in field, including Y.M. Dennis Lo, Rossa W.K. Chiu, Carl Wittwer, Noriko Kusukawa, Cindy Vnencak-Jones, Thomas Williams, Victor Weedn, Malek Kamoun, Howard Baum, Angela Caliendo, Aaron Bossler, Gwendolyn McMillin, and Kojo S.J. Elenitoba-Johnson. Highly-respected author team includes three editors who are well known in the clinical chemistry world. Reference values in the appendix give you one location for comparing and evaluating test results. NEW! Two-color design throughout highlights important features, illustrations, and content for a quick reference. NEW! Chapter on hemostasis provides you with all the information you need to accurately conduct this type of clinical testing. NEW! Six associate editors lend even more expertise and insight to the reference. NEW! Reorganized chapters ensure that only the most current information is included.
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. Expert Consult provides the entire text as a fully searchable eBook, and includes regular content updates, animations, podcasts, more than 1300 clinical case studies, over 2500 multiple-choice questions, a lecture series, and more. 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 on Expert Consult. NEW! Over 100 adaptive learning courses on Expert Consult offer the opportunity for personalized education.
Download or read book Statistical Methods in Biomarker and Early Clinical Development written by Liang Fang and published by Springer Nature. This book was released on 2019-12-26 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.
Download or read book Henry s Clinical Diagnosis and Management by Laboratory Methods E Book written by Richard A. McPherson and published by Elsevier Health Sciences. This book was released on 2021-06-09 with total page 1960 pages. Available in PDF, EPUB and Kindle. Book excerpt: For more than 100 years, Henry's Clinical Diagnosis and Management by Laboratory Methods has been recognized as the premier text in clinical laboratory medicine, widely used by both clinical pathologists and laboratory technicians. Leading experts in each testing discipline clearly explain procedures and how they are used both to formulate clinical diagnoses and to plan patient medical care and long-term management. Employing a multidisciplinary approach, it provides cutting-edge coverage of automation, informatics, molecular diagnostics, proteomics, laboratory management, and quality control, emphasizing new testing methodologies throughout. Remains the most comprehensive and authoritative text on every aspect of the clinical laboratory and the scientific foundation and clinical application of today's complete range of laboratory tests. Updates include current hot topics and advances in clinical laboratory practices, including new and extended applications to diagnosis and management. New content covers next generation mass spectroscopy (MS), coagulation testing, next generation sequencing (NGS), transfusion medicine, genetics and cell-free DNA, therapeutic antibodies targeted to tumors, and new regulations such as ICD-10 coding for billing and reimbursement. Emphasizes the clinical interpretation of laboratory data to assist the clinician in patient management. Organizes chapters by organ system for quick access, and highlights information with full-color illustrations, tables, and diagrams. Provides guidance on error detection, correction, and prevention, as well as cost-effective test selection. Includes a chapter on Toxicology and Therapeutic Drug Monitoring that discusses the necessity of testing for therapeutic drugs that are more frequently being abused by users.
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 Ligand Binding Assays written by Masood N. Khan and published by John Wiley & Sons. This book was released on 2009-10-22 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: A consolidated and comprehensive reference on ligand-binding assays Ligand-binding assays (LBAs) stand as the cornerstone of support for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning interest in the pharmaceutical industry. Yet, outside of the Crystal City Conference proceedings, little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena answers that growing need, serving as a reference text discussing critical aspects of the development, validation, and implementation of ligand-binding assays in the drug development field. Ligand-Binding Assays covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include: A general discussion of challenges and proven approaches in the development of ligand-binding assays More detailed examination of characteristics of these assays when applied to support of pharmacokinetic and toxicokinetic studies of compounds at different stages in the discovery or development timeline A concise, but detailed, discussion of validation of ligand-binding assays for macromolecules A practical approach to "fit-for-purpose" validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies Written by a team of world-recognized authorities in the field, Ligand-Binding Assays provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry.
Download or read book Contemporary Practice in Clinical Chemistry written by William Clarke and published by Academic Press. This book was released on 2020-06-11 with total page 1070 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contemporary Practice in Clinical Chemistry, Fourth Edition, provides a clear and concise overview of important topics in the field. This new edition is useful for students, residents and fellows in clinical chemistry and pathology, presenting an introduction and overview of the field to assist readers as they in review and prepare for board certification examinations. For new medical technologists, the book provides context for understanding the clinical utility of tests that they perform or use in other areas in the clinical laboratory. For experienced laboratorians, this revision continues to provide an opportunity for exposure to more recent trends and developments in clinical chemistry. Includes enhanced illustration and new and revised color figures Provides improved self-assessment questions and end-of-chapter assessment questions
Download or read book Bioanalytical Aspects in Biological Therapeutics written by Xiaohui (Sophia) Xu and published by John Wiley & Sons. This book was released on 2022-07-06 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.
Download or read book Advances in Clinical Chemistry written by and published by Academic Press. This book was released on 2009-08-03 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume 47 in the internationally acclaimed Advances in Clinical Chemistry contains chapters submitted from leading experts from academia and clinical laboratory science. Authors are from a diverse field of clinical chemistry disciplines and diagnostics, ranging from basic biochemical exploration to cutting-edge microarray technology. Leading experts from academia and clinical laboratory science Volume emphasizes novel laboratory advances with application to clinical laboratory diagnostics and practical basic science studies
