Discover how analytical chemistry supports the latest clinical research This book details the role played by analytical chemistry in fostering clinical research. Readers will discover how a broad range of analytical techniques support all phases of clinical research, from early stages to the implementation of practical applications. Moreover, the contributing authors' careful step-by-step guidance enables readers to better understand standardized techniques and steer clear of everyday problems that can arise in the lab. Analytical Techniques for Clinical Chemistry opens with an overview of the legal and regulatory framework governing clinical lab analysis. Next, it details the latest progress in instrumentation and applications in such fields as biomonitoring, diagnostics, food quality, biomarkers, pharmaceuticals, and forensics. Comprised of twenty-five chapters divided into three sections exploring Fundamentals, Selected Applications, and Future Trends, the book covers such critical topics as: Uncertainty in clinical chemistry measurements Metal toxicology in clinical, forensic, and chemical pathology Role of analytical chemistry in the safety of drug therapy Atomic spectrometric techniques for the analysis of clinical samples Biosensors for drug analysis Use of X-ray techniques in medical research Each chapter is written by one or more leading pioneers and experts in analytical chemistry. Contributions are based on a thorough review and analysis of the current literature as well as the authors' own firsthand experiences in the lab. References at the end of each chapter serve as a gateway to the literature, enabling readers to explore individual topics in greater depth. Presenting the latest achievements and challenges in the field, Analytical Techniques for Clinical Chemistry sets the foundation for future advances in laboratory research techniques.
The Retinoids: Biology, Biochemistry, and Disease provides an overview and synthesis of the retinoid molecules, from basic biology to mechanisms of diseases and therapy. Divided into five sections, the book covers retinoic acid signaling from biochemical, genetic, developmental, and clinical perspectives. The text is divided into five sections, the first of which examines vitamin A metabolic and enzymatic pathways. Focus then shifts to the role of retinoic acid signaling in development, and then to retinoids and physiological function. The book concludes with chapters on retinoids, disease and therapy. Comprehensive in scope and written by leading researchers in the field, The Retinoids: Biology, Biochemistry, and Disease will be an essential reference for biologists, biochemists, geneticists and developmental biologists, as well as for clinicians and pharmacists engaged in clinical research involving retinoids.
The emerging field of green analytical chemistry is concerned with the development of analytical procedures that minimize consumption of hazardous reagents and solvents, and maximize safety for operators and the environment. In recent years there have been significant developments in methodological and technological tools to prevent and reduce the deleterious effects of analytical activities; key strategies include recycling, replacement, reduction and detoxification of reagents and solvents. The Handbook of Green Analytical Chemistry provides a comprehensive overview of the present state and recent developments in green chemical analysis. A series of detailed chapters, written by international specialists in the field, discuss the fundamental principles of green analytical chemistry and present a catalogue of tools for developing environmentally friendly analytical techniques. Topics covered include: Concepts: Fundamental principles, education, laboratory experiments and publication in green analytical chemistry. The Analytical Process: Green sampling techniques and sample preparation, direct analysis of samples, green methods for capillary electrophoresis, chromatography, atomic spectroscopy, solid phase molecular spectroscopy, derivative molecular spectroscopy and electroanalytical methods. Strategies: Energy saving, automation, miniaturization and photocatalytic treatment of laboratory wastes. Fields of Application: Green bioanalytical chemistry, biodiagnostics, environmental analysis and industrial analysis. This advanced handbook is a practical resource for experienced analytical chemists who are interested in implementing green approaches in their work.
The study and management of abnormal heart rhythms is the core of Electrophysiology, but the successful identification and management of arrhythmias is important to a much wider range of physicians, from trainees in cardiology to general clinical cardiologists to practitioners in other areas of specialization, for example internists. This book is a thorough overview of clinical arrhythmology designed to help general clinical cardiologists and trainees in the fields of clinical cardiology and electrophysiology achieve the competency they need for clinical practice or for further specialization in the topics covered within the book.
Integrated Clinical Orthodontics provides an important new resource on the clinical interactions between the practice of orthodontics and other areas of clinical dentistry and medicine. Having at its heart the paradigm of patient-centred care, the book not only integrates the knowledge, skills, and experience of all the disciplines of dentistry and medicine, but also eases the work of orthodontists in arriving at an accurate diagnosis and a comprehensive treatment plan. Presented in a highly visual and practical format, Integrated Clinical Orthodontics uses clinical case presentations to illustrate the rationale and application of the integrated approach to a variety of clinical scenarios. Integrated Clinical Orthodontics covers areas of complexity in clinical orthodontics, specifically the role of the orthodontist as a member of a multidisciplinary team. The book outlines and details the management of congenital orofacial deformities, sleep disorders, esthetic smile creation and temporomandibular joint problems, and additionally and importantly includes specific protocols for effective communication with experts in other specialties.
Phycotoxins are a diverse group of poisonous substances produced by certain seaweed and algae in marine and fresh waters and are important to the scientific community for many reasons, the most obvious being that they pose food safety issues which requires a large investment to regularly monitor the presence of these compounds in foods. Phycotoxins: Chemistry and Biochemistry, second edition presents the most updated information available on phycotoxins. Major emphases are given to chemistry and biochemistry, while origins, mechanism of action, toxicology, and analytical methodology are also covered. Since the publication of the first edition, there have been major advances in the science of marine and aquatic toxins, as well as advances in toxicology, analytical chemistry and pharmacology. This fully revised and updated edition includes several new chapters, including those on ciguatoxins, pinnatoxin, ichthyotoxins, as well as new chapters on food safety control of marine toxins, climate change and water toxins, and microalgae as a source of nutraceuticals. The book will be of interest to toxicologists, marine, food, and plant scientists, as well as researchers and academics in the areas of food science, medicine, public health, toxicology, pharmacology and marine biology.
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code
Human Blood Groups is a comprehensive and fully referenced text covering both the scientific and clinical aspects of red cell surface antigens, including: serology, inheritance, biochemistry, molecular genetics, biological functions and clinical significance in transfusion medicine. Since the last edition, seven new blood group systems and over 60 new blood group antigens have been identified. All of the genes representing those systems have now been cloned and sequenced. This essential new information has made the launch of a third edition of Human Blood Groups, now in four colour, particularly timely. This book continues to be an essential reference source for all those who require clinical information on blood groups and antibodies in transfusion medicine and blood banking.
The textbook has been written according to the approved curriculum in biological chemistry for medical students specializing in Stomatology. It contains illustrated text of lectures on biochemistry as well as list of references and tests for knowledge control which can be used by students for biochemistry study.
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Provides an introduction to the various statistical techniques involved in medical research and drug development with a focus on estimating the success probability of an experiment Success Probability Estimation with Applications to Clinical Trials details the use of success probability estimation in both the planning and analyzing of clinical trials and in widely used statistical tests. Devoted to both statisticians and non-statisticians who are involved in clinical trials, Part I of the book presents new concepts related to success probability estimation and their usefulness in clinical trials, and each section begins with a non-technical explanation of the presented concepts. Part II delves deeper into the techniques for success probability estimation and features applications to both reproducibility probability estimation and conservative sample size estimation. Success Probability Estimation with Applications to Clinical Trials: • Addresses the theoretical and practical aspects of the topic and introduces new and promising techniques in the statistical and pharmaceutical industries Features practical solutions for problems that are often encountered in clinical trials Includes success probability estimation for widely used statistical tests, such as parametric and nonparametric models Focuses on experimental planning, specifically the sample size of clinical trials using phase II results and data for planning phase III trials Introduces statistical concepts related to success probability estimation and their usefulness in clinical trials Success Probability Estimation with Applications to Clinical Trials is an ideal reference for statisticians and biostatisticians in the pharmaceutical industry as well as researchers and practitioners in medical centers who are actively involved in health policy, clinical research, and the design and evaluation of clinical trials.
This book in the new American Heart Association Clinical Series, explores and explains state-of-the-art use of antiplatelet agents and draws on the expertise of global leaders in antiplatelet therapy. Skillfully organized for fast reference, the book is divided into five parts: Concepts in Platelet Physiology, Function, and Measurement Pharmacology of Oral Antiplatelet Agents Pharmacology of Intravenous Antiplatelet Agents Clinical Use of Antiplatelet Agents in Cardiovascular Disease Special Circumstances. Each chapter in the clinical section contains an overview of guidelines, plus specifics on medical and interventional uses. Clinical cardiologists, platelet biologists, and a wide range of practicing and prospective clinicians in allied fields will find this text an exceptional source of current information.
Offering a concise, illustrated summary of biochemistry and its relevance to clinical medicine, Medical Biochemistry at a Glance is intended for students of medicine and the biomedical sciences such as nutrition, biochemistry, sports science, medical laboratory sciences, physiotherapy, pharmacy, physiology, pharmacology, genetics and veterinary science. It also provides a succinct review and reference for medical practitioners and biomedical scientists who need to quickly refresh their knowledge of medical biochemistry. The book is designed as a revision guide for students preparing for examinations and contains topics that have been identified as 'high-yield' facts for the United States Medical Licensing Examination (USMLE), Step 1. This third edition: Has been thoroughly revised and updated and is now in full colour throughout Is written by the author of the hugely successful Metabolism at a Glance (ISBN 9781405107167) Features updated and improved clinical correlates Expands its coverage with a new section on Molecular Biology Includes a brand new companion website of self-assessment questions and answers at www.ataglanceseries.com/medicalbiochemistry