The second edition of this standard text guides biomedical researchers in the selection and use of advanced statistical methods and the presentation of results to clinical colleagues. It assumes no knowledge of mathematics beyond high school level and is accessible to anyone with an introductory background in statistics. The Stata statistical software package is again used to perform the analyses, this time employing the much improved version 10 with its intuitive point and click as well as character-based commands. Topics covered include linear, logistic and Poisson regression, survival analysis, fixed-effects analysis of variance, and repeated-measure analysis of variance. Restricted cubic splines are used to model non-linear relationships. Each method is introduced in its simplest form and then extended to cover more complex situations. An appendix will help the reader select the most appropriate statistical methods for their data. The text makes extensive use of real data sets available at http://biostat.mc.vanderbilt.edu/dupontwd/wddtext/.

An unprecedented compilation of state-of-the-art advances in clinical research on diabetes and obesity by premier clinical scientists around the world. This volume critically reviews the limitations and strengths of today's major techniques in clinical diabetes research, and then reviews how those methods have been used to carry out cutting-edge studies of carbohydrate, lipid, and protein metabolism in the disease.

The study of human reproduction has focused on reproductive 'success' and on the struggle to achieve this, rather than on the much more common experience of 'failure', or reproductive loss. Drawing on the latest research from The UK and Europe, The United States, Australia and Africa, this volume examines the experience of reproductive loss in its widest sense to include termination of pregnancy, miscarriage, stillbirth, perinatal and infant death, as well as - more broadly - the loss of desired normative experiences such as that associated with infertility, assisted reproduction and the medicalisation of 'high risk' pregnancy and birth. Exploring the commonalities, as well as issues of difference and diversity, Understanding Reproductive Loss presents international work from a variety of multi-disciplinary perspectives and will appeal to sociologists, anthropologists and other social scientists with interests in medicine, health, the body, death studies and gender.

Medicinal Chemistry: A Look at How Drugs Are Discovered is written for those who are interested in learning how drugs are discovered. Compared to other books on the market, this text takes a different approach by presenting the subject on chemical reaction mechanism terms, which ideally makes the subject matter more interesting and easier to comprehend. The authors describe the drug discovery process, from advancing an initial lead to the approval process, and include drug discovery sources. Additional features: Explains medicinal chemistry on chemical mechanism terms, allowing for a more interesting and easier to comprehend text Includes valuable insights toward the various pathways taken at pharmaceutical industries in drug discoveries Improved by including questions raised and suggestions made from students in the authors' medicinal chemistry classes This book will benefit both upper level undergraduates and graduates studying in the fields of medicinal chemistry and drug discovery, as well as scientists working in the pharmaceutical industry.

The leading figure in qualitative health research (QHR), Janice M. Morse, asserts that QHR is its own separate discipline--distinct from both traditional health research and other kinds of qualitative research--and examines the implications of this position for theory, research, and practice. She contends that the health care environments transform many of the traditional norms of qualitative research and shape a new and different kind of research tradition. Similarly, the humanizing ethos of qualitative health research has much to teach traditional researchers and practitioners in health disciplines. She explores how the discipline of QHR can play out in practice, both in the clinic and in the classroom, in North America and around the world. A challenging, thought-provoking call to rethink how to conduct qualitative research in health settings.

Led by both children s rights perspectives and methodological arguments, there is an increasing emphasis on children and young people s participation in health and social care research by researchers, policy makers and funding bodies with many now considering the active involvement of children and young people a requirement. There is little exploration of how to address and overcome the many challenges arising from their participation, however.

Divided into five parts, this practical book begins by considering what research with young people is and why we should do it, before leading the reader into how to undertake it. The book then provides practical examples of action and finishes with reflections about the whole process. Bringing together a variety of experienced researchers, from a wide range of backgrounds in health and social care and including young people, the chapters provide insight for practical action, as well as critical and theoretical reflection. Involving Children and Young People in Health and Social Care Research includes issues on:

• Understanding the reasons and processes for involving children and young people in research
• Making sure that involvement is meaningful and not merely tokenistic
• Developing research methods that are commensurate with different ages and abilities
• Ensuring adequate training and preparation, for children, young people and adults to make involvement meaningful
• Power and relationships between young people researchers and adult researchers
• Sustaining young people s interest and motivation
• Addressing ethical issues that arise throughout the research journey

Committed to partnership and participation throughout the entire process of the active involvement of children and young people in health and social care research, this text provides invaluable insights and is a resource for all those conducting research in and with children and young people.

One of the first studies of an exciting new development in global biotechnology, this cutting edge text examines the extent of the transnational movements of tissues, stem cells, and expertise, in the developing governance framework of India.

Documenting the impact of local and global governance frames on the everyday conduct of research, this groundbreaking book traces the journey of spare human embryos in IVF clinics to public and private laboratories engaged in isolating stem cells for potential therapeutic application. The discussion also examines the gender dimension as a potential site for exploitation in the sourcing of embryonic and other biogenic materials, and suggests that a moral economy has developed in which the ethical values of the global 'North' support and encourage the donation of abundant and ethically neutral embryos by the 'South'.

This unique exploration is grounded in an empirical, multi-sited ethnographic study that takes a thoroughly comparative analysis of the ethical, religious and social issues in Europe, the United States, and organ donations already prevalent in India. In this theoretically-sensitive analysis, the authors use the resources of social anthropology and the social sciences in an innovative text which will appeal to postgraduates and professionals in the areas of STS studies, genetics, bioethics, and anthropology.

This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental industrial and clinical perspective reflecting the many advances in techniques and methodology. The title will cover new material including the use of enzymes for the synthesis and resolution of enantiomeric compounds as well, as their use in drug discovery; how stereochemistry impacts on decisions taken during the ADMET (absorption, distribution, metabolism, excretion, toxicity) stage of drug discovery; issues faced during the final stages of the drug development process; the impact of ICH (International Conference on Harmonisation) on the use of single isomer drugs; racemic switches; and legal perspectives looking at IP and patent issues surrounding chiral switches and marketing single enantiomer switches.

This Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.

New topics include:

• The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery
• How stereochemistry impacts decisions made in the Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) stages of drug discovery
• A chapter on pharmacokinetics and pharmacodynamics that discusses the issues faced during the final stages of the drug development process
• The impact of International Conference on Harmonisation on the use of single isomer drugs
• Chiral switches
• The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs
• A chapter on the legal perspectives of patent issues surrounding chiral switches and the marketing of single enantiomer switches
• This will be a one-stop shop for pharmaceutical scientists and chemists working with chiral drug molecules
  

The main focus of this book is on brown adipose tissue and its metabolic function. The book provides a timely update on the latest research and shows where the field is heading. Brown adipose tissue (BAT) dissipates energy and has received considerable attention in the last few years, having been re-discovered in adult humans in 2007/9. Moreover, BAT might offer a target for novel therapies to address obesity, a health condition that has reached pandemic dimensions.

This book provides an introduction to the principles of both cardiovascular epidemiology and molecular pathophysiology; as a unique aspect, it also outlines and discusses the molecular concepts underlying epidemiological observations. This second volume is focused on all aspects concerning "secondary risk factors" in terms of diseases associated with enhanced risk for cardiovascular events. The book promotes the use of interdisciplinary approaches in the field of preventive medicine based on recent advances in molecular and cellular pathophysiology. The book offers a valuable resource for researchers in basic biomedical fields and clinical scientists alike, as well as guidelines for novel avenues of research in both basic pathophysiology and cardiovascular therapy and prevention.

The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig s origins, anatomy, genetics, immunology, and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. Regulatory aspects of its use are considered.

The reader will find an extensive amount of theoretical and practical information in the pharmacology; ADME and toxicology chapters which will help scientists and managers when deciding which species to use in basic research; drug discovery and pharmacology; and toxicology studies of chemicals, biotechnology products and devices. The book discusses regulatory uses of minipigs in the evaluation of human and veterinary pharmaceuticals, medical devices, and other classes of xenobiotics. It describes features of normal health, normal laboratory values, and common diseases. It also carefully elucidates ethical and legal considerations in their supply, housing, and transport. The result is an all-inclusive and up to date manual about the experimental uses of the minipig that describes How to and Why and What to expect in the normal, combining enthusiasm and experience with critical assessment of its values and potential problems."

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Second EditionAlong with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives. Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.

This fully updated edition provides selected mouse genetic techniques and their application in modeling varieties of human diseases. The chapters are mainly focused on the generation of different transgenic mice to accomplish the manipulation of genes of interest, tracing cell lineages, and modeling human diseases. 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 up-to-date, Mouse Genetics: Methods and Protocols, Second Edition delivers fundamental techniques and protocols to geneticists, molecular biologists, cell and developmental biologists, students, and postdoctoral fellows working in the various disciplines of genetics, developmental biology, mouse genetics, and modeling human diseases.

The purpose of this book is to provide an overview of the biology of the planorbid snail Biomphalaria glabrata mainly as related to the snail 's role as a host of larval trematodes . This snail is of great importance in medical and economic zoology as a vector of important trematode (fluke) diseases in human and veterinary medicine and in wildlife biology. Moreover, this snail is a useful model for numerous basic studies in biology and chemistry. A book that provides modern coverage of diverse topics from the molecule to the community of this snail as related to larval trematode parasitism is not available. This book should appeal to a wide audience of biologists, ecologists, biochemists, malacologists, parasitologists, public health workers, epidemiologists, and graduate and advanced undergraduate students in biomedical and allied health sciences.

The authoritative source on clinical data management Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text will be a timely publication in an ever-changing field. The volume:

• Is written by well-known and experienced authors in this area
• Provides new approaches to major topics in clinical data management
• Contains new chapters on systems software validation, database design and performance measures

This valuable new book, Handbook of Research on Medicinal Chemistry: Innovations and Methodologies, presents some of the latest advancements in the various fields of combinatorial chemistry, drug discovery, biochemical aspects, pharmacology of medicinal agents, current practical problems, and nutraceuticals. The editors keep the drug molecule as the central component of the volume and aim to explain the associated features essential to exhibiting pharmacological activity. With a unique combination of chapters in biology, clinical aspects, biochemistry, synthetic chemistry, medicine and technology, the volume provides broad exposure to the essential aspect of pharmaceuticals. The volume many important aspects of medicinal chemistry, including techniques in drug discovery pharmacological aspects of natural products chemical mediators: druggable targets advances in medicinal chemistry The field of medicinal chemistry is growing at an unprecedented pace, and this volume takes an interdisciplinary approach, covering a range of new research and new practices in the field. The volume takes into account the latest therapeutic guidelines put forward by the World Health Organization and the U.S Food and Drug Administration.. Topics include: drug design drug discovery natural products and supplements and nutraceuticals pharmaceutical approaches to sexual dysfunction drug resistance parasites new natural compounds and identification of new targets stereochemistry aspects in medicinal chemistry common drug interactions in daily practices Handbook of Research on Medicinal Chemistry: Innovations and Methodologies will be a valuable addition to the bookshelves of pharmaceutical scientists and faculty as well as for industry professionals.

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon. Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.

The detrimental effects of incomplete data sets on the results of clinical trials are both well known and all too commonly recurrent. It is essential that the correct statistical methodology be applied in order to effectively analyse the results of trials affected by missing data.

Missing Data in Clinical Trials provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described.

Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism. Illustrated throughout with real-life case studies and worked examples from clinical trials. Details the use and implementation of the necessary statistical software, primarily SAS.

Missing Data in Clinical Trials has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.

From Napoleon's penis to Van Gogh's ear, from Marie Antoinette's teeth to Marie Curie's bone marrow, this book brings together the remarkable stories of body parts that have made history. We have always used and abused bodies. We've torn them apart, dug them up, experimented on them or taken bits home to display as trophies. Body parts have been used for propaganda in wars and pulled off in punishment. They've answered medical mysteries, been turned into relics and even saved lives. Now TikTok sensation and medical historian, Dr Suzie Edge, brings us a history of the world's most famous body parts told through its most notable limbs, organs, and appendages, including how Queen Victoria's armpit led the development of antiseptics; why Percy Shelley's heart refused to burn; and the strange case of Hitler's right testicle.

This book discusses the fundamental concepts of the green synthesis of nanoparticles and presents the latest advances in this emerging field. Providing a comprehensive overview of developments related to nanoparticle synthesis using fungi, algae, bryophytes, pteridophytes, gymnosperms, monocotyledons, dicotyledonous (angiosperms) and animal systems, it also explores techniques for the characterization of these nanoparticles. Lastly, it reviews the applications and toxicity of biologically synthesized green nanoparticles. Given its scope, it is a valuable resource for students, researchers and policymakers working in the field of nanobiotechnology and nanoscience.

Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

This volume explores the dynamic topic of tight junctions. The book focuses on tight junctions' role in sealing adjacent epithelial cells in a narrow band just beneath their apical surface. The book explains how tight junctions consist of a network of claudins and other proteins, and delves into how they hold cells together and form functional and protective barriers, regulating the passage of molecules and ions through the space between cells. The book opens with a discussion of the evolution of research on tight junctions, discussing a range of primary areas of growth, including the current knowledge on the particular physiological function of different claudins due to the development of an array of knock out mice. The chapters also explore in-depth studies of tight junctions in specific tissues (gut, lung and endothelia). This book offers a comprehensive understanding on post-translational modifications of occludin and its impact on tight junction function, as well as the molecular composition and function of tricellular tight junctions. This volume is particularly relevant to students and scientists in neuroscience, cell biology, physiology, cell differentiation, and cancer research.

Understanding Research in Clinical and Counseling Psychology, Second Edition, is written and designed for graduate students in the psychology and counseling fields, for whom the value of psychological research is not always readily apparent. Contributed to by experts in their respective fields, this text presents research as an indispensable tool for practice, a tool that is used every day to advance knowledge and improve assessment, treatment choice, and client outcomes. The book is divided into four logical parts: Research Foundations, Research Strategies, Research Practice, and finally, Special Problems. Included is a chapter that addresses one of the most important controversies, the distinction between realistic and "gold standard" efficacy studies. The remainder of the book addresses salient issues such as conducting research in various cultures, operating an empirically-oriented practice, and performing research with families, children, and the elderly. Students and professors will find the coverage ample and penetrating, without being too overwhelming.

As a result of new statistical and mathematical approaches, improved visualization tools, and recognition by international regulatory groups, quantitative structure-activity relationships (QSARs) now play important roles in pharmacology for the design of new drugs as well as in toxicology and ecotoxicology for hazard identification and risk assessment. Providing up-to-date coverage of the field, Three Dimensional QSAR: Applications in Pharmacology and Toxicology presents the most recent QSAR methods and illustrates their scope, advantages, and limitations. Part I The first part of the book addresses CoMFA and related methods, such as CoMSIA, FLUFF, SOMFA. It also describes shape-, surface-, and volume-based approaches, including MSA, excluded volume, LIV, HASL, receptor surface model, COMPASS, and CoMSA. Part II Focusing on methods that use 3D information, the second part covers autocorrelation methods, such as GRIND; similarity-based methods, including similarity matrices and quantum similarity indices; and quantitative spectroscopic data-activity relationships. Some applications in data mining are also explored. Part III The third part deals with post-3D models. The authors discuss the adaptation of the receptor and simultaneous presence of several conformers or solvation mechanisms. Part IV The final part presents receptor-related approaches as well as docking and free energy calculations, which are treated at various levels. This part concerns the extensive sampling of phase space and approximate methods, such as linear interaction energy, Poisson-Boltzmann, and generalized Born models. A case study covering several parallel approaches is also developed. An appendix offers the basic principles of modeling and statistical tools routinely required in QSAR methodologies, including optimization methods, molecular mechanics and dynamics, multivariate analysis, nonlinear models, and evolutionary techniques. It provides newcomers