This book describes some of the key epidemiological principles, scientific approaches and quality assurance frameworks required to design and conduct biobank studies in various settings. Using examples from contemporary biobanks, the book addresses the design features and practical procedures needed in order to launch and manage biobank studies, including consent and regulatory approval, the organisation of field work, management of data and biological samples, follow-up and verification of disease outcomes, development of IT systems for data collection, quality assurance and study management. Over the last two decades, several large biobank studies have been initiated in different populations, intended to greatly enhance the development of precision medicine. Contemporary biobank studies are extremely large and complex, and involve several decades of follow-up. Such studies pose major challenges in terms of ensuring rapid recruitment, obtaining high-quality data, minimising loss to follow-up, reliably classifying disease outcomes, and optimising the use of the biological samples collected. In this regard, the key to success lies not in planning the perfect study, but in planning the most appropriate, reliable, sustainable and future-proof study given the practical constraints of available resources, time and capacity. The authors of this handbook are epidemiologists, clinicians, software engineers, and laboratory and data scientists with extensive experience in conducting large biobank studies. The eight chapters can be read separately or together, and provide readers with essential information on how to design, implement and manage these studies. The state-of-the-art, innovative and scalable approaches and methodologies presented here are intended to stimulate the development of further population-based and hospital-based biobank studies in diverse populations.

This book provides systematic knowledge of basic principles in the design of fluorescence sensing and imaging techniques together with critical analysis of recent developments. Fluorescence is the most popular technique in chemical and biological sensing because of its ultimate sensitivity, high temporal and spatial resolution and versatility that enables imaging within the living cells. It develops rapidly in the directions of constructing new molecular recognition units, new fluorescence reporters and in improving sensitivity of response up to detection of single molecules. Its application areas range from control of industrial processes to environment monitoring and clinical diagnostics. Being a guide for students and young researchers, it also addresses professionals involved in active basic and applied research. Making a strong link between education, research and product development, this book discusses prospects for future progress.

This detailed volume explores protocols for studying the many facets of Ca2+-imaging, Ca2+-signaling, and Ca2+-binding along with background information on the principles and application of these techniques. The content of the book delves into 48 chapters including subjects such as data analysis and modern technologies to study calcium-binding and signaling in cells, the superfamily of calcium-binding proteins characterized by the EF-hand structural motif, as well as their use as diagnostic and prognostic biomarkers in Laboratory Medicine and novel therapeutic drug targets. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and comprehensive, Calcium-Binding Proteins of the EF-Hand Superfamily: From Basics to Medical Applications presents state-of-the-art, lab-based methods and easy-to-follow protocols for daily use, making it interesting for basic and medical researchers, cell- and molecular biologists, clinicians, clinical chemists, and the diagnostic industry.

Proper nutrition is the single most important component of preventative health care. Heart disease, diabetes, and other ailments are all linked to dietary habits. Accurate nutritional assessment can be a matter of life or death.
Laboratory Tests for the Assessment of Nutritional Status explores the expanded number of nutrients that can now be evaluated. The author makes a compelling case for the practice and advancement of this critical health care tool. Nutritional assessment identifies undernutrition, overnutrition, specific nutrition deficiencies, and imbalances. Diligent assessment determines the appropriate nutrition intervention and monitors its effects.
This book is a total revision of the 1974 version of the same title co -authored by Sauberlich. Since then, remarkable progress has been made on the methodologies applicable to nutrition status assessment and to the expanded number of nutrients that can be evaluated, especially trace elements. The introduction of high-performance liquid chromatography, amperometric detectors, and other technologies has advanced nutritional assessment by leaps and bounds. Today, nutritionists can gauge the value of microminerals, trace elements, and ultratrace elements. Sauberlich's revision updates the reader to the latest and most important trends in nutrition. These laboratory methods for the assessment of nutritional status are vital for identifying individuals as well as populations with nutritional risks.

In Vitro Toxicology Systems brings together important issues and considerations needed in order to develop a workable, reliable, integrated testing strategy for the replacement of animals in toxicity testing regimes. This thorough volume includes sections on in vitro models for systemic organ toxicity, neurotoxicity, sensory organs, immunotoxicity and reproductive toxicity and addresses how stem cells may be used going forward. The book also tackles difficult areas of toxicology such as carcinogenicity and nanotoxicology, with additional chapters dedicated to kinetics, metabolism, and in vitro in vivo extrapolation. The book also addresses biological processes such as stress response pathways and mechanistic biomarkers and how these can be uncovered and measured using high content approaches. Reliable and authoritative, In Vitro Toxicology Systems will be of benefit not only to students, scientists and regulators working in the field of chemical safety assessment but also to a wider scientific audience.

This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmuller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements

Saliva as a unique sample for health assessment is gaining attention among researchers of different fields in the last 20 years; being reflected in an impressive increase in the number of papers published studying saliva from different biological aspects in human and veterinary species. Once deemed merely a digestive juice is now considered a biological fluid capable of communicating information about physiopathological processes occurring in organisms, since saliva has been shown to contain molecular and bacterial compounds that can change in response to local and systemic pathologies. Furthermore, the interest of saliva as a diagnostic, prognostic and monitoring biofluid is forced by its non-invasive nature being of easy and inexpensive sampling, involving only minimal discomfort and allowing the collection of multiple/repeated specimens at anytime, anywhere and without need for specialized staff. In this contributed volume, the authors bring together, summarize and reflect the generated knowledge about saliva as a source of biomarkers for health and welfare evaluation in humans and animal models. This volume also highlights the importance of confounding factors, such as sampling methods, flow, total protein content, contamination, or storage. This book will serve as a manual for graduates, practitioners and researchers by providing general ideas about the possibilities and utilities of saliva in clinical practice or investigation, and indicating the main cautions each should have in mind before saliva usage.

The textbook is based on the APPLIED use of laboratory instrumentation and apparatus in practice in the real working world with absolute minimum use of complex calculations and mathematics. Instrumental theory is kept to a minimum, with useful practical hints and unbiased instruction on lab instruments' capabilities and operations. All text is in simple to understand language of the complexities of chemical analyses.

This book presents the latest data from basic research and clinical trials supporting the effectiveness of ketamine as a treatment for depression, bipolar disorder, and suicidal behavior, setting these positive findings within the context of the serious problem of ketamine abuse. The first part of the book focuses on the evidence regarding ketamine abuse, with specific reference to Asian countries, and discusses countermeasures and complication management. It then addresses the mechanisms underlying the antidepressant and side effects of ketamine, which have remained elusive, describing and discussing important new research findings. Further, it explains insights gained from whole brain imaging in rodents and from behavioral pharmacology, and presents evidence regarding the role of gut microbiota, the NMDA receptor GluN2D subunit, and the lateral habenula in the actions of ketamine. These advances form the basis for the safer use of ketamine in patients with treatment-resistant depression and are expected to lead to the development of new antidepressants.

This book is a compilation of experimentally determined solubility ranges of over 1,700 compounds in the National Toxicology Program's Chemical Repository. Each compound's solubility was determined in a consistent manner in one to six solvents. Solvents chosen were those most commonly used for toxicology studies, spill cleanups, and chemical synthesis or chemical reaction experiments. These solvents include acetone, 95% ethanol, water, dimethyl sulfoxide, methanol, and toluene. Data for many of the research and industrial chemicals featured in this volume do not exist anywhere else. If you are a toxicologist, safety professional, industrial hygienist, or chemist, this book is a valuable reference tool you'll find yourself using every day.

This book provides an introduction to the principles of pharmacogenomics and precision medicine, followed by the pharmacogenomics aspects of major therapeutic areas such as cardiovascular disease, cancer, organ transplantation, psychiatry, infection, antithrombotic drugs. It also includes genotyping technology and therapeutic drug monitoring in Pharmacogenomics; ethical, Legal and Regulatory Issues; cost-effectiveness of pharmacogenetics-guided treatment; application of pharmacogenomics in drug discovery and development and clinical Implementation of Pharmacogenomics for Personalized Precision Medicine. The contributors of Pharmacogenomics in Precision Medicine come from a team of experts, including professors from academic institutions and practitioner from hospital. It will give an in-depth overview of the current state of pharmacogenomics in drug therapy for all health care professionals and graduate students in the era of precision medicine.

Animal experimentation has long been a controversial issue, with impassioned arguments on both sides of the debate. Increasingly, it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved. Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics included are: the safety evaluation of chemicals; international validation and barriers to the validation of alternative tests; in vitro testing for endocrine disruptors; intelligent approaches to safety evaluation of chemicals; alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate students wishing to pursue a career in the pharmaceutical and cosmetics industries.

The over-arching goal of this volume is to help infertility practitioners evaluate and manage their patients with poor semen quality. The authors review the existing literature on the effects of medications on male fertility, and provide detailed information about what is known, giving the number of individuals and population characteristics for studies of medication effects on male fertility. Medications are designed to treat illness and reduce symptoms, but all have undesirable adverse effects such as headache or stomach upset. Some adverse reactions can even be life-threatening, so it is no surprise that some drugs have negative effects on male reproduction. Medical practitioners rarely consider a man's reproductive plans when prescribing medications. Men are routinely treated with drugs that can impair or abolish fertility. Although practitioners in the field of reproductive medicine generally realize that certain drugs impact negatively on reproductive health, there are limited resources providing evidence-based knowledge useful in counseling patients. Tables throughout this volume summarize the information for each drug, providing a handy reference for clinical use.

The book provides a reference for years to come, written by world-renowned expert investigators studying sex differences, the role of sex hormones, the systems biology of sex, and the genetic contribution of sex chromosomes to metabolic homeostasis and diseases. In this volume, leaders of the pharmaceutical industry present their views on sex-specific drug discovery. Many of the authors presented at the Keystone Symposium on "Sex and gender factors affecting metabolic homeostasis, diabetes and obesity" to be held in March 2017 in Lake Tahoe, CA. This book will generate new knowledge and ideas on the importance of gender biology and medicine from a molecular standpoint to the population level and to provide the methods to study them. It is intended to be a catalyst leading to gender-specific treatments of metabolic diseases. There are fundamental aspects of metabolic homeostasis that are regulated differently in males and females, and influence both the development of diabetes and obesity and the response to pharmacological intervention. Still, most preclinical researchers avoid studying female rodents due to the added complexity of research plans. The consequence is a generation of data that risks being relevant to only half of the population. This is a timely moment to publish a book on sex differences in diseases as NIH leadership has asked scientists to consider sex as a biological variable in preclinical research, to ensure that women get the same benefit of medical research as men.

The atlas of the Light and Specular Microscopy of the Cornea, particularly of the corneal endothelium presents photographs of healthy and pathological corneas, as well as corneas prepared for grafting. Photographs are taken from donor or patient's corneas. The first part section of the atlas shows healthy corneas and its particular layers: the epithelium (superficial and basal cells, subepithelial nerve plexus), stroma and keratocytes, and the endothelium. Blood vessels or palisades of Vogt in limbus are shown as well. The second part section that shows corneas processed for grafting is focused focuses on the endothelial layer. Main causes of exclusion of corneas from grafting, such as the presence of dead cells, polymeghatism, pleomorphism, cornea guttata or stromal scars have been shown. The third part section of the atlas shows corneas before and after storage in tissue cultures or hypothermic conditions with the aim to assess its suitability of for tissue for grafting. The last final section contains photographs of pathological corneal explants

This book discusses in detail various serological tests that are used to identify medical conditions and diseases, from a general overview of each test to the equipment and steps needed to carry them out. The book is aimed specifically at immunology students and professionals who may occasionally need to use these tests, and thus lack training and experience in performing them. The book provides a brief overview of the immune system, including antibodies, antigens, and their interactions. The bulk of the book is comprised of 16 chapters that each explain different serological tests. These chapters start with a general introduction of the test or disease being detected, followed by the test principle, reagents required for the test, procedures and steps to perform the test, and, finally, result interpretation. Both test principles and result interpretation segments include illustrations to aid comprehension. In addition, the book also enables the reader to distinguish between positive and negative results in serological testing.

Prepared under the auspices of the American College of Laboratory Animal Medicine, this second edition has been thoroughly updated and revised to improve utility and readability. The book is now organized by vertebrate host species, with parasites presented phylogenetically within chapters. Additional highlights of this edition include introductory chapters on modern diagnostic techniques and parasite biology, and a new appendix features a complete drug formulary. The well-presented and extensively illustrated volume addresses all aspects of laboratory animal parasites. Regarded as the most comprehensive and authoritative work available on the topic, this book is an essential reference for veterinary parasitologists, clinicians, students and laboratory animal scientists.

Plasmodium falciparum malaria is responsible for the deaths of nearly 500,000 people each year. Much attention has been paid to antibody and cellular mechanisms of immunity against this pathogen. By contrast, the role that the complement system plays in immunity and pathogenesis in this infection is not very well recognized or understood. Based on the work of a number of research groups, we know that complement plays an important role in these processes. In this book, some of the leading scientists in the field discuss the mechanisms of complement activation during malaria infection as well as the role of complement in the pathogenesis of key syndromes such as severe malarial anemia, cerebral malaria, and placental malaria. In addition, they review recently-identified complement evasion strategies of P. falciparum merozoites, and how these mechanisms may translate into paradoxical enhancement of infection rather than protection. Finally, they also discuss the role of the mosquito complement system on immunity against the parasite.

Cardiovascular immunology is a newly emerging research area, investigating the crosstalk between the cardiovascular and the immune system. This crosstalk is evident through (1) crucial immunological capacities and functions of cardiovascular cell types, including cardiomyocytes, fibroblasts, endothelial cells, pericytes and cardiac resident macrophages, (2) the impact of aberrant immune function on the development of cardiovascular disease such as atherosclerosis, direct and indirect immune-mediated heart disease and vasculitis, and (3) the crucial role of the immune system in cardiac repair and regeneration. The Immunology of Cardiovascular Homeostasis and Pathology covers all these aspects of cardiovascular immunology, starting with homeostatic immunological functions of traditional cardiovascular cell types, and moving then to the role of the immune system in cardiovascular pathology and to recent research into targeting the immune system to boost cardiac healing and regeneration.

This book explains how SaaS works and lists and describes many common misconceptions and pitfalls that laboratories have about implementing Quality Management Systems (QMS). By walking the reader through all ISO 15189 Standards and describing each in detail, we can show how to implement them in common sense and meaningful ways. This book demonstrates to clinical laboratories how to combine the rigor of international standards with the inherent benefits of contemporary cloud-based software systems so that they can involve the entire laboratory in making quality a shared habit.

This book provides basic, simple, and logical explanations for choices to be made to run the best Elispot possible. It allows the newcomer to truly understand the best options for specific protocol steps, reagents and materials, and provides even the experienced Elispot user with insight into best practices. The techniques presented here are supported by the author's twenty-plus years of first-hand experience working with this assay, as well as the shared experiences of numerous colleagues and collaborators. The enzyme-linked immunospot (Elispot) assay is a widely used technique to monitor cells on the single cell level for the release of analytes like cytokines, chemokines or immunoglobulins (antibodies), in response to particular stimuli. The most important feature of Elispot is its outstanding sensitivity, allowing the detection of specific cells in very low frequencies. The advantages of Elispot have resulted in it being widely adapted for use in research and translational applications in numerous fields including cancer, infectious diseases, autoimmunity, and transplantation.

Olesja Rissling analyzes the potential interaction of mycophenolic acid (MPA) and pantoprazole. MPA is used as an immunosuppressive drug to prevent acute organ rejections after organ transplantation. Pantoprazole, known to interact with the bioavailability of drugs, is used to prevent upper gastrointestinal disorders. The author performed a clinical pharmacokinetic study in renal transplant patients to evaluate a potential interaction of MPA and pantoprazole. The bioavailability and the maximum concentration of MPA were determined with or without pantoprazole intake. An influence on the immunosuppressive effect was evaluated by measuring the target enzyme activity. Overall, no significant change in the bioavailability or the maximum concentration was found. Similar results were obtained for the target enzyme activity after pantoprazole intake with MPA. The results suggest that the interaction of pantoprazole with MPA does not compromise the immunosuppressive effect to a clinically meaningful extent.

The clinical laboratory is often known as a "black box" to nurses, physicians, and surgeons, but this concise book removes the veil by covering all the pertinent aspects of the clinical laboratory. This book bridges between medicine and chemistry by offering an overview to a clinical laboratory's structure and function, the importance of laboratory utilization and test ordering, as well as pre-analytical, analytical, and post-analytical issues of importance to recognize in any clinical laboratory. An interactive FAQ and a detailed index are also available.

This book presents the latest data from basic research and clinical trials supporting the effectiveness of ketamine as a treatment for depression, bipolar disorder, and suicidal behavior, setting these positive findings within the context of the serious problem of ketamine abuse. The first part of the book focuses on the evidence regarding ketamine abuse, with specific reference to Asian countries, and discusses countermeasures and complication management. It then addresses the mechanisms underlying the antidepressant and side effects of ketamine, which have remained elusive, describing and discussing important new research findings. Further, it explains insights gained from whole brain imaging in rodents and from behavioral pharmacology, and presents evidence regarding the role of gut microbiota, the NMDA receptor GluN2D subunit, and the lateral habenula in the actions of ketamine. These advances form the basis for the safer use of ketamine in patients with treatment-resistant depression and are expected to lead to the development of new antidepressants.

A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: *Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. *Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. *Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. *Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. *Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.