A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions. Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English. This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.

Childhood Obesity Prevention and Treatment, Second Edition summarizes the latest scientific knowledge on obesity in children. This edition focuses on the developmental aspects of obesity, especially on the influences and factors predisposing individuals to obesity from early periods of life. This new body of knowledge stems from both basic research and recent epidemiological and clinical studies. All chapters are updated and special attention is given to the prevention of obesity in the context of developmental physiology, lifestyle modification, and dietary and physical activity approaches. Highlighting the most recent research, this timely book covers a broad range of aspects related to the prevention and management of childhood obesity. It emphasizes early intervention and an integrated behavioral approach to overcome the ongoing challenge of this global epidemic. Features * Updates all chapters and includes new research on growing populations of obesity in the Third World * Provides information on promoting health as a means to reduce obesity * Focuses on the developmental aspects of obesity

Like an army of millions ready to defend its territory, the human immune system acts as the body's primary line of defense-a complex network of interacting cells that protects us from pathogens and other foreign substances. But many components of the immune system exhibit change after prolonged, heavy exertion, indicating that it is suppressed and stressed, albeit transiently, following prolonged endurance exercise. For marathon runners, distance swimmers and any other endurance athlete who undergoes repeated cycles of heavy exertion, a weakened immune system could lead to health complications such as respiratory infection. As a result, interest in various nutrient supplements with the potential to counter exercise-induced immunosuppression has grown. Nutrition and Exercise Immunology reviews the link between nutrition and immune function, with special application to athletic endeavor. Written by respected researchers in sports medicine and exercise immunology, this text covers topics such as carbohydrates and the immune response to prolonged exertion; protein, exercise, and immunity; and vitamins, immunity, and infection risk in athletes. It also takes a look at future directions in nutrition and exercise immunology. For sports medicine professionals, dietitians, nutritionists, exercise immunologists, as well as endurance athletes, Nutrition and Exercise Immunology provides an important and in-depth look into this exciting, new area of scientific research.

This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment. Examines excipients as a unique class of products and explores new procedures for determining toxicity! A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety identifies the differences between excipients (inactive ingredients), food ingredients, and drug products evaluates issues of dose administration, species selection, and study design for various routes of exposure provides detailed information on the historical uses of excipients in drug formulations clarifies the Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure explains how data generated in toxicity models are applied to identify hazards in drug formulations details exposure assessment to link hazard identification with risk considers the requirements and importance of purity specifications and much more! Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

This work provides descriptions, explanations and examples of the Bayesian approach to statistics, demonstrating the utility of Bayesian methods for analyzing real-world problems in the health sciences. The work considers the individual components of Bayesian analysis.;College or university bookstores may order five or more copies at a special student price, available on request from Marcel Dekker, Inc.

Co-published with the IEEE Press, this book is a practical, hands-on guide to EMC issues for medical device designers and installers. It addresses electromagnetic interference and covers the basics of EMC design, physics, and installation, minimizing theory and concentrating upon the correct way to ground and shield. Covering EMC from the inside out, the book provides the basics of electronics, discusses and evaluates problems and common causes, and explores effective remedial techniques at three levels: circuit, box, and interconnect. It contains appendices that provide important reference material such as constants and conversion factors.

Toxicokinetics in Risk Assessment discusses the noncancer risk assessment process and its reliance on uncertainty factors in order to facilitate the continued study and refinement of the scientific basis for health risk assessment. This text clearly demonstrates the application of physiologically-based pharmacokinetic (PBPK) modeling in human health risk assessment, as well as methods for data generation, extrapolation, and inclusion of laboratory results for chemical metabolism and computer-based predictions of biochemical constants to address estimates of variability between experimental animals and humans. This guide also includes recent examples of the use of toxicokinetic information to successfully replace default values for uncertainty factors with data-derived factors in risk assessments developed by the US Environmental Protection Agency.

Volume 3 takes the subject of better land husbandry further. The book first points out the sort of things which have been, and are being used, but are failing to deliver what is required. It then explains the causes of erosion, the theory and practice of soil and water conservation, and practical and lasting ways to construct terraces, including such details as how to build different kinds of terrace walls. Nothing grows from the top down, as also with soil improvement. It explains in detail the way of achieving practical and sustainable soil and water conservation, practical ways in which farmers can themselves make and use practical and lasting ways to construct terraces, including such details as how to build different kinds of terrace walls.

Focusing on prevention rather than treatment, Obesity: Dietary and Developmental Influences reviews and evaluates the determinants of obesity. The book uses evidence-based research as a basis to define foods and dietary behaviors that should be supported and encouraged as well as those that should be discouraged. This comprehensive review represents a critical step forward in the quest to identify actionable strategies to prevent obesity. The book describes the potential role of 26 different dietary factors and 8 developmental periods in the prevention of obesity among children and adults. The dietary factors examined include macronutrients, micronutrients, specific types of foods and beverages, snack and meal patterns, portion size, parenting practices, breastfeeding, and more. The factors from each developmental period in the life cycle are examined in the context of the likelihood of obesity development. For each dietary factor and developmental period, four lines of evidence are examined: secular trends, plausible mechanisms, observational studies, and prevention trials. Providing easy access to information, the book features 38 tables that summarize observational studies, 38 graphs depicting trends in dietary intake, and 9 tables that summarize prevention trials. It provides a synopsis of the latest research on obesity, investigating all major lines of evidence, and clarifies common misconceptions while identifying which behaviors to target and which dietary factors show the most promise for prevention.

Evolution by natural selection explains the tree of life and the complex adaptations found throughout nature. The power and versatility of evolutionary explanations have proved tempting to scientists outside of biology, but adapting evolutionary concepts to new domains has been challenging. Even within biology, there are many difficult questions and problem cases that face evolutionary theory. Modelling Evolution offers a new, general account of evolution by natural selection that identifies the essential features of evolutionary models that transcend any particular discipline. Evolution by natural selection in its broad sense is the systemic advantage of a type, in contrast to the narrow definition using heritable variation in fitness. This account is explained, contextualised and applied to a variety of questions in both biology and the social sciences. Offering an accessible and comprehensive account of evolution that is applicable both to biology and the broader social sciences, Modelling Evolution will appeal to students and researchers interested in fields such as biology, economics, sociology, history, and psychology.

This work examines the issue of accelerated soil erosion, which has become an increasingly serious concern in the twentieth century. Aspects considered include on-site impact of erosion; application of soil science to problems of non-agricultural uses of soil, such as mineland restoration, urban uses and disposal of urban wastes; soil contamination and pollution by industrial activities; and athletic and recreational uses of soil. Soil Quality and Soil Erosion will be a useful text for soil scientists, agronomists, foresters, and environmental scientists as we enter the next century.

Aims to provide in-depth descriptions of the latest developments in multiple comparison methods and selection procedures, while emphasizing biometry. This text is published in honour of the 70th birthday of Charles W. Dunnett - a pioneer in statistical methodology.

Polymeric materials are now playing an increasingly important role in pharmaceuticals, as well as in sensing devices, in situ prostheses and probes, and microparticle diagnostic agents. This new volume consists of twenty-two recent research-based reports on the developments in these areas of pharmaceutical and biomaterials technology. The reports were prepared by top scientists in the field and are based on current research conducted at leading laboratories in the U.S.A., Europe, and Asia. These 22 chapters report the latest information in the application of polymers to biological systems.

This unique book examines the beneficial aspects of animal waste as a soil resource - not simply as an agricultural by-product with minimal practical use. Topics include o types of livestock waste - swine, poultry, dairy o methods and management of waste utilization o storage, handling, processing and application of animal waste o supplying crop nutrients o economics of waste utilization o new modeling and management techniques o nonpoint source pollution, water quality, leaching, and air quality.

Although standard mixed effects models are useful in a range of studies, other approaches must often be used in correlation with them when studying complex or incomplete data. Mixed Effects Models for Complex Data discusses commonly used mixed effects models and presents appropriate approaches to address dropouts, missing data, measurement errors, censoring, and outliers. For each class of mixed effects model, the author reviews the corresponding class of regression model for cross-sectional data. An overview of general models and methods, along with motivating examples After presenting real data examples and outlining general approaches to the analysis of longitudinal/clustered data and incomplete data, the book introduces linear mixed effects (LME) models, generalized linear mixed models (GLMMs), nonlinear mixed effects (NLME) models, and semiparametric and nonparametric mixed effects models. It also includes general approaches for the analysis of complex data with missing values, measurement errors, censoring, and outliers. Self-contained coverage of specific topicsSubsequent chapters delve more deeply into missing data problems, covariate measurement errors, and censored responses in mixed effects models. Focusing on incomplete data, the book also covers survival and frailty models, joint models of survival and longitudinal data, robust methods for mixed effects models, marginal generalized estimating equation (GEE) models for longitudinal or clustered data, and Bayesian methods for mixed effects models. Background materialIn the appendix, the author provides background information, such as likelihood theory, the Gibbs sampler, rejection and importance sampling methods, numerical integration methods, optimization methods, bootstrap, and matrix algebra. Failure to properly address missing data, measurement errors, and other issues in statistical analyses can lead

Health professionals are recognizing the major role that nutraceuticals play in health enhancement. As a result, there is a dramatic increase in research aimed at identifying new functional foods and nutraceuticals. There is not, however, a single source that presents this research in a thorough and accessible manner. Comprehensive and complete, the Dictionary of Nutraceuticals and Functional Foods is the first reference of its kind written explicitly for this rapidly developing field. The book provides clearly written, concise, science-based information on over 470 nutraceutical and functional food products and compounds. Each entry lists the most current information on the product or compound and its role in the promotion of health or the prevention of disease, as well as peer-reviewed literature references. In addition, this thorough reference contains 172 chemical structures, 102 figures, 73 schemes, and 64 tables to facilitate recognition and understanding. Concise and accessible, the Dictionary of Nutraceuticals and Functional Foods is a convenientsingle source reference that defines the most commonly used terms in the field of nutraceuticals and functional foods.

Balancing the "cookbook" approach of some texts with the more mathematical approach of others, Nonparametric Statistical Methods for Complete and Censored Data introduces commonly used non-parametric methods for complete data and extends those methods to right censored data analysis. Whenever possible, the authors derive their methodology from the general theory of statistical inference and introduce the concepts intuitively for students with minimal backgrounds. Derivations and mathematical details are relegated to appendices at the end of each chapter, which allows students to easily proceed through each chapter without becoming bogged down in a lot of mathematics. In addition to the nonparametric methods for analyzing complete and censored data, the book covers optimal linear rank statistics, clinical equivalence, analysis of block designs, and precedence tests. To make the material more accessible and practical, the authors use SAS programs to illustrate the various methods included. Exercises in each chapter, SAS code, and a clear, accessible presentation make this an outstanding text for a one-semester senior or graduate-level course in nonparametric statistics for students in a variety of disciplines, from statistics and biostatistics to business, psychology, and the social scientists. Prerequisites: Students will need a solid background in calculus and a two-semester course in mathematical statistics.

"Provides current models, tools, and examples for the formulation and evaluation of scientific hypotheses in causal terms. Introduces a new method of model parametritization. Illustrates structural equations and graphical elements for complex causal systems."

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques. Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

This book demonstrates that nutrients play a direct role as co-factors and regulators of the immune system. The book also shows that modulating the immune response with nutrients can provide a fundamental approach to preventive medicine.;Containing nearly 2300 bibliographic citations as well as illustrative figures, tables, and micrographs, this book is designed to be of interest to clinical immunologists, immunology and vitamin researchers, nutrition specialists, paediatricians, neonatologists, and upper-level undergraduate, graduate, and medical school students in these disciplines.

Unravelling Long COVID An authoritative medical reference on the various ways in which Long-COVID presents and an in-depth discussion of its mechanisms and potential therapeutic options. Unravelling Long COVID aims to provide a better awareness and understanding of the persistent health problems that can arise following SARS-CoV-2 infection. Variously described as Long-COVID, Long-Haulers' Syndrome, and Post-Acute Sequelae of SARS-CoV-2, this newly-designated disorder is estimated to have affected somewhere between 50 to 250 million people. It is in fact considered by many as the next global public health disaster. With such a broad and important topic, the authors of Unravelling Long COVID have focused primarily on two major problems in the current understanding of Long-COVID: 1.) the failure to distinguish patients with organ damage--here called Long-COVID Disease - and those with unexplained, persistent symptoms--what is termed Long-COVID syndrome, and 2.) the failure of current medical approaches to comprehend and treat those persistent unexplained symptoms. Unravelling Long COVID is: One of the first books focused specifically on defining and understanding Long-COVID with the goal of establishing optimal management A unique reference to distinguish patients with organ damage caused by Long-COVID disease from those with unexplained, persistent symptoms that manifest as Long-COVID syndrome An in-depth exploration of neuroimmune pathways to help clarify the previously unexplained symptoms of Long-COVID Unravelling Long COVID is an essential reference for anyone interested in Long-COVID and the impact that this condition has had on the population. It will be a useful resource for both patients suffering from the Long-Covid syndrome, their physicians and for the growing number of Long-COVID clinics that have been established across the US, the UK, and other countries.

Bayesian Modeling in Bioinformatics discusses the development and application of Bayesian statistical methods for the analysis of high-throughput bioinformatics data arising from problems in molecular and structural biology and disease-related medical research, such as cancer. It presents a broad overview of statistical inference, clustering, and classification problems in two main high-throughput platforms: microarray gene expression and phylogenic analysis. The book explores Bayesian techniques and models for detecting differentially expressed genes, classifying differential gene expression, and identifying biomarkers. It develops novel Bayesian nonparametric approaches for bioinformatics problems, measurement error and survival models for cDNA microarrays, a Bayesian hidden Markov modeling approach for CGH array data, Bayesian approaches for phylogenic analysis, sparsity priors for protein-protein interaction predictions, and Bayesian networks for gene expression data. The text also describes applications of mode-oriented stochastic search algorithms, in vitro to in vivo factor profiling, proportional hazards regression using Bayesian kernel machines, and QTL mapping. Focusing on design, statistical inference, and data analysis from a Bayesian perspective, this volume explores statistical challenges in bioinformatics data analysis and modeling and offers solutions to these problems. It encourages readers to draw on the evolving technologies and promote statistical development in this area of bioinformatics.

The pace and sophistication of advances in medicine in the past two decades have necessitated a growing need for a comprehensive reference that highlights current issues in medicine. Each volume in the Current Issues in Medicine series is a stand-alone text that provides a broad survey of various critical topics-all accomplished in a user-friendly yet interconnected format. The series not only highlights current advances but also explores related topics such as translational medicine, regulatory science, neglected diseases, global pandemics, patent law, immunotoxicology, theranostics, big data, artificial intelligence, novel imaging tools, combination drug products, and novel therapies. While bridging the gap between basic research and clinical medicine, this series provides a thorough understanding of medicine's potential to address health problems from both the patient's and the provider's perspectives in a healthcare setting. The range of topics covered and the expertise of the contributing authors accurately reflect the rapidly evolving areas within medicine-from basic medical sciences to clinical specialties. Each volume is essential reading for physicians, medical students, nurses, fellows, residents, undergraduate and graduate students, educators, policymakers, and biomedical researchers. The multidisciplinary approach of the series makes it a valuable reference resource for the pharmaceutical industry, academia, and governments. However, unlike other series on medicine or medical textbooks, this series focuses on current trends, perspectives, and issues in medicine that are central to healthcare delivery in the 21st century. Volume 1 focuses on the current issues in basic medical sciences, subjects that are fundamental to the practice of medicine. Specifically, it covers medical biochemistry, genomics, physiology, and pathology. These subjects, traditionally taught in the first two years of medical school that precede clinical instruction, provide a core of basic knowledge critical to the success in clinical medicine during rotations, training, and medical practice.

The pace and sophistication of advances in medicine in the past two decades have necessitated a growing need for a comprehensive reference that highlights current issues in medicine. Each volume in the Current Issues in Medicine series is a stand-alone text that provides a broad survey of various critical topics-all accomplished in a user-friendly yet interconnected format. The series not only highlights current advances but also explores related topics such as translational medicine, regulatory science, neglected diseases, global pandemics, patent law, immunotoxicology, theranostics, big data, artificial intelligence, novel imaging tools, combination drug products, and novel therapies. While bridging the gap between basic research and clinical medicine, this series provides a thorough understanding of medicine's potential to address health problems from both the patient's and the provider's perspectives in a healthcare setting. The range of topics covered and the expertise of the contributing authors accurately reflect the rapidly evolving areas within medicine-from basic medical sciences to clinical specialties. Each volume is essential reading for physicians, medical students, nurses, fellows, residents, undergraduate and graduate students, educators, policymakers, and biomedical researchers. The multidisciplinary approach of the series makes it a valuable reference resource for the pharmaceutical industry, academia, and governments. However, unlike other series on medicine or medical textbooks, this series focuses on current trends, perspectives, and issues in medicine that are central to healthcare delivery in the 21st century. Volume 2 focuses on the current issues in basic medical sciences, subjects that are fundamental to the practice of medicine. Specifically, it discusses clinical immunology, medical microbiology, COVID-19, and big data. These subjects, traditionally taught in the first two years of medical school that precede clinical instruction, provide a core of basic knowledge critical to the success in clinical medicine during rotations, training, and medical practice.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.