While regression models have become standard tools in medical research, understanding how to properly apply the models and interpret the results is often challenging for beginners. Regression Models as a Tool in Medical Research presents the fundamental concepts and important aspects of regression models most commonly used in medical research, including the classical regression model for continuous outcomes, the logistic regression model for binary outcomes, and the Cox proportional hazards model for survival data. The text emphasizes adequate use, correct interpretation of results, appropriate presentation of results, and avoidance of potential pitfalls. After reviewing popular models and basic methods, the book focuses on advanced topics and techniques. It considers the comparison of regression coefficients, the selection of covariates, the modeling of nonlinear and nonadditive effects, and the analysis of clustered and longitudinal data, highlighting the impact of selection mechanisms, measurement error, and incomplete covariate data. The text then covers the use of regression models to construct risk scores and predictors. It also gives an overview of more specific regression models and their applications as well as alternatives to regression modeling. The mathematical details underlying the estimation and inference techniques are provided in the appendices.

This timely book provides a succinct summary of methods for the synthesis of bioactive heterocycles using a multicomponent reaction (MCR) approach. The majority of pharmaceuticals and biologically active agrochemicals are heterocycles while countless additives and modifiers used in industrial applications are heterocyclic in nature. With the recent introduction of high-throughput biological evaluation, the importance of MCRs for drug discovery has been recognized and considerable efforts have been focused especially on the design and development of multi-component procedures for the generation of various bioactive heterocycles due to their significant therapeutic potential.

Presents health benefits and medicinal importance of dietary polyphenols having antioxidative effects and their possible preventive role against oxidative stress (OS)-induced chronic human diseases Summarizes latest understanding on the biochemical mechanism(s) involved in the antioxidative action of dietary polyphenols along with their bioavailability, pharmacokinetic, and toxicological considerations Highlights novel approaches of drug discovery from dietary polyphenols through computational screening of bioactive phytochemical components

Contents:
Preface Acknowledgements The Pacific Theatre, World War II Introduction Part I. Japanese Factories of Death 1. Manchuria 2. Ishii Shiro 3. The Beiyinhe Bacteria Factory 4. Phase 1. Building Ping Fan 5. Phase 2. Hell in Ping Fan 6. The Secret of Secrets: Human Experiments 7. The Death Factory in Changchun 8. The Death Factory in Nanking 9. Experiments on prisoners of War 10. Who Knew? Part II. American Cover-Up The American Biological Warfare Program 12. Discovery of the Secret of Secrets 13. Investigations 14. Scientists and the Cover-Up 15. The Military and the Cover-Up 16. Epilogue Notes Select Bibliography Index

New Developments in Dementia Prevention Research addresses a dearth of knowledge about dementia prevention and shows the importance of considering the broader social impact of certain risk factors, including the role we each play in our own cognitive health throughout the lifespan. The book draws on primary and secondary research in order to investigate the relationship between modifiable factors, including vascular and psychosocial risks, that may affect the incidence of dementia. Bringing together world-leading expertise from applied science, medicine, psychology, health promotion, epidemiology, health economics, social policy and primary care, the book compares and contrasts scientific and service developments across a range of settings. Each chapter presents these themes in a way that will ensure best practice and further research in the field of dementia prevention is disseminated successfully throughout the world. Perhaps most importantly, chapters also question what type of social responsibility we are prepared to embrace in order to address the challenges inherent in dementia prevalence. New Developments in Dementia Prevention Research includes contributions from leading authorities in brain health and dementia prevention and provides an essential contribution to the discourse on dementia prevention. It will be of great interest to academics, researchers and postgraduate students engaged in the study of the psychological and social aspects of aging and dementia.

Biotechnology is a multidisciplinary field encompassing microbiology, bichemistry, genetics, molecular biology, chemistry, immunology, cell and tissue culture physiology. This book describes the recent developments in these areas. Current research topics such as Quorum sensing, Integrons, Phytomining are discussed, which would serve as an excellent reference work for both academicians and researchers in the field.

In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives. The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices. With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.

The microfluidic lab-on-a-chip allows scientists to conduct chemical and biochemical analysis in a miniaturized format so small that properties and effects are successfully enhanced, and processes seamlessly integrated. This microscale advantage translates into greater sensitivity, more accurate results, and better information. Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery focuses on all aspects of the microfluidic lab-on-a-chip technologies and offers an overview of the available technology, its limitations, and its breakthroughs over the years. It emphasizes analytical applications of microfluidic technology and offers in-depth coverage of micromachining methods, microfluidic operations, chemical separations, sample preparation and injection methods, detection technology, and various chemical and biological analyses. Other topics of interest include the use of polymeric chips, fluid flow valve and control, single-cell analysis, DNA and RNA amplification techniques, DNA hybridization, immunoassays and enzymatic assays. Originally conceived as a single chapter published in Ewing's Analytical Instrumentation, this book is a gateway to the vast literature and conference proceedings on the topic. Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery expands upon its roots to present a comprehensive treatment of microfluidic lab-on-a-chip methods and applications for novices and advanced researchers alike.

Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug

This new book educates readers about new technologies before they appear in hospitals, enabling medical physicists and clinicians to prepare for new technologies thoroughly and proactively, and provide better patient care once new equipment becomes available. Emerging technologies in imaging, treatment planning, treatment delivery, dosimetry and informatics are all discussed. The book is divided into three parts: recently developed technologies available for practice; technologies under development nearing completion; and technologies in an early stage of development that could have potential radiotherapy applications. Features: Introduces emerging technologies in imaging, treatment planning, treatment delivery, dosimetry and informatics The advantages and limitations of each technology in clinical settings are discussed, and recommendations on how to adopt the technologies are provided Critiques and improvement points are provided for researchers, in addition to suggestions on how to prepare quality assurance are provided as needed

FROM THE PREFACE The field of medical devices represents one of the most advanced technological areas in the United States. In 1991, over 12 million Americans had at least one medical device; fixation devices had the highest incidence, followed by contact lens use and lens implants and, lastly, artificial joints. The public has come to expect that medical devices will alleviate maladies and/or conditions that were not treatable fifty years ago. It is hard to believe that the first pacemaker was invented in the 1950s, the first artificial heart valve in 1952, and the first artificial hip replacement was performed in 1954. In 1992, the medical device industry exported a total of $6.9 billion, while the country imported a total of $3.9 billion, representing a $3.0 billion trade surplus. Medical devices are among the most regulated products in the world. The FDA maintains a constant vigil over medical device manufacturers and importers; even medical device definitions are subject to official scrutiny. Title 21 of the Code of Federal Regulations publishes these definitions, but the definitions are spread over several medical specialty areas and are, thus, difficult to find. This book attempts to bring a measure of order by providing an alphabetical listing of officially defined devices.

Building on its best-selling predecessors, Basic Statistics and Pharmaceutical Statistical Applications, Third Edition covers statistical topics most relevant to those in the pharmaceutical industry and pharmacy practice. It focuses on the fundamentals required to understand descriptive and inferential statistics for problem solving. Incorporating new material in virtually every chapter, this third edition now provides information on software applications to assist with evaluating data. New to the Third Edition Use of Excel (R) and Minitab (R) for performing statistical analysis Discussions of nonprobability sampling procedures, determining if data is normally distributed, evaluation of covariances, and testing for precision equivalence Expanded sections on regression analysis, chi square tests, tests for trends with ordinal data, and tests related to survival statistics Additional nonparametric procedures, including the one-sided sign test, Wilcoxon signed-ranks test, and Mood's median test With the help of flow charts and tables, the author dispels some of the anxiety associated with using basic statistical tests in the pharmacy profession and helps readers correctly interpret their results using statistical software. Through the text's worked-out examples, readers better understand how the mathematics works, the logic behind many of the equations, and the tests' outcomes.

Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website.

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in the healthcare field. The book provides valuable insight on where to look for information and material on sample size and statistical techniques commonly used in clinical research, and on how best to communicate with clinicians. It also covers the best practices to adopt in terms of project, time, and data management; relationship with collaborators; etc.

In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development (such as bioavailability/bioequivalence), bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems. Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia.

Measures of Interobserver Agreement and Reliability, Second Edition covers important issues related to the design and analysis of reliability and agreement studies. It examines factors affecting the degree of measurement errors in reliability generalization studies and characteristics influencing the process of diagnosing each subject in a reliability study. The book also illustrates the importance of blinding and random selection of subjects. New to the Second Edition New chapter that describes various models for methods comparison studies New chapter on the analysis of reproducibility using the within-subjects coefficient of variation Emphasis on the definition of the subjects' and raters' population as well as sample size determination This edition continues to offer guidance on how to run sound reliability and agreement studies in clinical settings and other types of investigations. The author explores two ways of producing one pooled estimate of agreement from several centers: a fixed-effect approach and a random sample of centers using a simple meta-analytic approach. The text includes end-of-chapter exercises as well as downloadable resources of data sets and SAS code.

Recent Advancement in Prodrugs Drugs used as medicines have many limitations like low chemical stability, aqueous solubility, or oral absorption/bioavailability, rapid presystemic metabolism, toxicity, inadequate site specificity, or poor patient acceptance/compliance (unwanted adverse effects, unacceptable taste or odor, irritation or pain). Prodrugs design is an approach to overcome these limitations. Key features Covers recent advancements in development of prodrugs Presents balanced synthesis and applications of prodrug chemistry Discusses broad spectrum of prodrug categories and outlines industrial applications Reviews prodrugs in cancer nanomedicine, its therapy and treatment Elucidates mathematical models to study the kinetics of prodrugs This book covers recent advances in the design of prodrugs. It contains all the significant recent examples of prodrug chemistry developments and will aid academics and researchers seeking to generate new projects in the field.

Features Represents the first book to provide comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials Describes the up-to-date theory and practice for model-assisted designs Presents many practical challenges and issues arising from early-phase clinical trials Illustrates with many real trial applications Offers numerous tips and guidance on designing dose finding and optimization trials Provides step-by-step illustration of using software to design trials Develops a companion website (www.trialdesign.org) to provide easy-to-use software to assist learning and implementing model-assisted designs.

Discover the Most Advanced Technologies in Biomagnetics Co-edited by Professor Ueno, a leader in the biomagnetics field for over 40 years, Biomagnetics: Principles and Applications of Biomagnetic Stimulation and Imaging explains the physical principles of biomagnetic stimulation and imaging and explores applications of the latest techniques in neuroscience, clinical medicine, and healthcare. The book shows you how the techniques are used in hospitals and why they are so promising. A brief overview of recent research trends in biomagnetics provides you with an up-to-date, informative guide to explore further in this field. The book focuses on three important areas: Magnetic nerve stimulation and transcranial magnetic stimulation Biomagnetic measurements and imaging of the human brain by advanced technologies of magnetoencephalography and MRI Biomagnetic approaches to potential treatments of cancers, pains, and other neurological and psychiatric diseases, such as Alzheimer's disease and depression These core areas of the book were developed from the editors' prestigious graduate-level courses in biomedical engineering. The text also discusses biomagnetic approaches to advanced medicine, including regenerative and rehabilitation medicine.

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

A volume in the new Principles and Applications in Engineering series, Tissue Engineering provides an overview of the major physiologic systems of current interest to biomedical engineers: cardiovascular, endocrine, nervous, visual, auditory, gastrointestinal, and respiratory. It contains useful definitions, tables of basic physiologic data, and an introduction to the literature. Then, the book reviews the status of tissue engineering of specific organs, including bone marrow, skeletal muscle, and cartilage. Readers will acquire a good understanding of the engineering and cell biological fundamentals of tissue engineering and will develop ideas for further development of this emerging and important field.

Biomimetics is the idea of creating new technologies abstracted from what we find in biology. Ocean Innovation: Biomimetics Beneath the Waves seeks that technological inspiration from the rich biodiversity of marine organisms. Bringing both a biological and engineering perspective to the biomimetic potential of oceanic organisms, this richly illustrated book investigates questions such as: How can we mimic the sensory systems of sea creatures like sharks, sea turtles, and lobsters to improve our ability to navigate underwater? What can we do to afford humans the opportunity to go unnoticed by marine life? How can we diffuse oxygen from water to enable deep diving without the risk of decompression sickness? Each chapter explores an area where we, as divers and technologists, can benefit from understanding how animals survive in the sea, presenting case studies that demonstrate how natural solutions can be applied to mankind's engineering challenges.

Over the past several decades there has been increasing research interest in thermodynamics as applied to biological systems. This concerns topics such as muscle work and internal energy such as fat and starch. Applications of the first and second laws of thermodynamics to the human body are important to dieticians and health science experts, and applications of these concepts to the animal body are a major concern of animal scientists. This book covers these key topics, which are typically not covered in classic or traditional thermodynamics texts used in mechanical and chemical engineering.

One of Nature's most important talents is evolutionary development of systems capable of molecular recognition: distinguishing one molecule from another. Molecular recognition is the basis for most biological processes, such as ligandreceptor binding, substrate-enzyme reactions and translation and transcription of the genetic code and is therefore of universal interest. Over the past four decades, researchers have been inspired by Nature to produce biomimetic materials with molecular recognition properties, by design rather than by evolution. A particularly exciting area of biomimetics is Molecular Imprinting, which can be defined as process of template-induced formation of specific recognition sites (binding or catalytic) in a material where the template directs the positioning and orientation of the material's structural components by a self-assembling mechanism. The material itself could be oligomeric (the typical example is DNA replication process), polymeric (organic MIPs and inorganic imprinted silica gels) or 2-dimensional surface assembly (grafted monolayers). Essentially the current progress in the field of molecular imprinting is a result of fundamental achievements made by more than a hundred groups working in the areas of non-covalent and reversible covalent imprinting. The goal of this title is to capture this momentum and publish a new book that will reflect the current situation in this rapidly evolving technology. Very few of the tens of reviews already published on this subject present a critical analysis of the technological aspects of molecular imprinting. Leaders in this field have been approached with requests to provide their views and analyses of specific areas of design, characterization and application of these polymers. The main body of Molecular Imprinting of Polymers starts with chapters covering polymer design, synthesis, and characterization that are prepared by well-recognized experts such as Andrew Mayes and Natalia Perez-Moral, Claud