Details methods for computing valid limits of detection. Clearly explains analytical detection limit theory, thereby mitigating incorrect detection limit concepts, methodologies and results Extensive use of computer simulations that are freely available to readers Curated short-list of important references for limits of detection Videos, screencasts, and animations are provided at an associated website, to enhance understanding Illustrated, with many detailed examples and cogent explanations

For decades gas chromatography has been and will remain an irreplaceable analytical technique in many research areas for both quantitative analysis and qualitative characterization/identification, which is still supplementary with HPLC. This book highlights a few areas where significant advances have been reported recently and/or a revisit of basic concepts is deserved. It provides an overview of instrumental developments, frontline and modern research as well as practical industrial applications. The topics include GC-based metabolomics in biomedical, plant and microbial research, natural products as well as characterization of aging of synthetic materials and industrial monitoring, which are contributions of several experts from different disciplines. It also contains best hand-on practices of sample preparation (derivatization) and data processing in daily research. This book is recommended to both basic and experienced researchers in gas chromatography.

This practical book in instrumental analytics conveys an overview of important methods of analysis and enables the reader to realistically learn the (principally technology-independent) working techniques the analytical chemist uses to develop methods and conduct validation. What is to be conveyed to the student is the fact that analysts in their capacity as problem-solvers perform services for certain groups of customers, i.e., the solution to the problem should in any case be processed in such a way as to be "fit for purpose". The book presents sixteen experiments in analytical chemistry laboratory courses. They consist of the classical curriculum used at universities and universities of applied sciences with chromatographic procedures, atom spectrometric methods, sensors and special methods (e.g. field flow fractionation, flow injection analysis and N-determination according to Kjeldahl). The carefully chosen combination of theoretical description of the methods of analysis and the detailed instructions given are what characterizes this book. The instructions to the experiments are so detailed that the measurements can, for the most part, be taken without the help of additional literature. The book is complemented with tips for effective literature and database research on the topics of organization and the practical workflow of experiments in analytical laboratory, on the topic of the use of laboratory logs as well as on writing technical reports and grading them (Evaluation Guidelines for Laboratory Experiments). A small introduction to Quality Management, a brief glance at the history of analytical chemistry as well as a detailed appendix on the topic of safety in analytical laboratories and a short introduction to the new system of grading and marking chemicals using the "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)", round off this book. This book is therefore an indispensable workbook for students, internship assistants and lecturers (in the area of chemistry, biotechnology, food technology and environmental technology) in the basic training program of analytics at universities and universities of applied sciences.

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.

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

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

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

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.