Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.

Neglected Diseases: Extensive Space for Modern Drug Discovery provides in-depth reviews on the last progresses about neglected tropical diseases research. Topics covered in this volume include Leishmaniasis, Tripanosomiasis, Onchocerciasis and Ebolavirus infections, with insights on the future of the research on them. Part of the volume is devoted to recent contributions this field received from X-Ray crystallography.

Sphingolipids in Cancer, Volume 140, the latest release in the Advances in Cancer Research series, provides invaluable information on the exciting and fast-moving field of cancer research. Topics discussed in this updated volume include Mechanisms of ceramide-dependent cancer cell death, Sphingolipids as regulators of autophagy and endocytic trafficking, The role and function of sphingomyelin biosynthesis in the development of cancer, Neutral sphingomyelinases in cancer: Friend or foe?, Sphingolipid rendezvous at the crossroad of NAFLD and senescence, Ceramide signaling and p53 pathways, Sphingolipid regulation of RNA Biology in cancer phenotypes, The role of ceramide-1-phosphate in tumor cell survival and dissemination, and more.

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.

A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.

This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts.
An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicinesA number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan)Acomprehensive guide for performing risk management more effectively throughout a product s life-cycle"

The philosopher Henry Richardson's short book is a defense of a position on a neglected topic in medical research ethics. Clinical research ethics has been a longstanding area of study, dating back to the aftermath of the Nazi death-camp doctors and the Tuskegee syphilis study. Most ethical regulations and institutions (such as Institutional Review Boards) have developed in response to those past abuses, including the stress on obtaining informed consent from the subject. Richardson points out that that these ethical regulations do not address one of the key dilemmas faced by medical researchers - whether or not they have obligations towards subjects who need care not directly related to the purpose of the study, termed 'ancillary care obligations'. Does a researcher testing an HIV vaccine in Africa have an obligation to provide anti-retrovirals to those who become HIV positive during the trial? Should a researcher studying a volunteer's brain scan, who sees a possible tumor, do more than simply refer him or her to a specialist? While most would agree that some special obligation does exist in these cases, what is the basis of this obligation, and what are its limits? Richardson's analysis of those key questions and the development of his own position are at the heart of this book, which will appeal to bioethicists studying research ethics, to policy makers, and to political and moral philosophers interested in the obligations of beneficence, one of the key issues in moral theory.

The authors of this book argue that there is a great divide between species that makes extrapolation of biochemical research from one group to another utterly invalid. In their previous book, "Sacred Cows and Golden Geese: The Human Cost of Experiments on Animals", the Greeks showed how an amorphous but insidious network of drug manufacturers, researchers dependent on government grants to earn their living, even cage-manufacurers - among others benefiting from "white-coat welfare" - have perpetuated animal research in spite of its total unpredictability when applied to humans. (Cancer in mice, for example, has long been cured. Chimps live long and relatively healthy lives with AIDS. There is no animal form of Alzheimer's disease.) In doing so, the Greeks aimed to blow the lid off the "specious science" we have been culturally conditioned to accept. Taking these revelations one step further, this book uses accessible language to provide the scientific underpinning for the Greeks' philosophy of "do no harm to any animal, human or not," by examining paediatrics, diseases of the brain, new surgical techniques, in vitro research, the Human Genome and Proteome Projects, an array of scien

The primary aim of Writing Research is to create a frame of reference for writing research from a number of approaches to inquiry; and for a number of purposes. The content is directed to identifying principles for writing from within commonly used methodologies and methods in health research, which will guide writers to transform research data into written forms. The emphasis will be on the writing task, not on how to conduct the research, which follows after research data has been collected. The explanatory aspects of the content of the book will assist researchers in the development of research proposals and those who critique or review research for any purpose. The theory and practice of research writing are comprehensively covered. Information on how to arrange material for specific purposes is provided. A range of commonly used research approaches is encompassed, and the writing task is discussed from within each. The writing process is linked to a philosophical basis of the research approach.

For all its costs, flaws, and inequities, American health care is fundamentally rooted in a belief that treatment should be based on solid scientific research. To this end, between 2003 and 2010, three different federal laws were enacted, the most recent being the Affordable Care Act of 2010, that mandated new federal investments in a type of clinical research called comparative effectiveness research (CER) - research into what works best in medical care. Comparative Effectiveness Research: Evidence, Medicine, and Policy provides the first complete account of how - and why - the federal government decided to make CER an important feature of health reform. Despite earlier legislative uptake of policy proposals on CER, support for federal mandates took dramatic twists and turns, with eventual compromises forged amid failing bipartisan alliances, special interests, and mobilized public opinion. Based on exhaustive research and first-hand interviews, the authors examine where CER fits in the production of scientific evidence about the benefits and harms of treatments for human diseases and conditions. Their work offers sobering confirmation that contemporary American medical care falls, not surprisingly, well short of the evidence-based ideal. Comparative Effectiveness Research demonstrates that dealing constructively with the vast uncertainties inherent to medical care requires policies to make the generation of high-quality evidence an inseparable part of routine health care.

Free Radicals in Biology and Medicine has become a classic text in the field of free radical and antioxidant research. Now in its fifth edition, the book has been comprehensively rewritten and updated whilst maintaining the clarity of its predecessors. Two new chapters discuss 'in vivo' and 'dietary' antioxidants, the first emphasising the role of peroxiredoxins and integrated defence mechanisms which allow useful roles for ROS, and the second containing new information on the role of fruits, vegetables, and vitamins in health and disease. This new edition also contains expanded coverage of the mechanisms of oxidative damage to lipids, DNA, and proteins (and the repair of such damage), and the roles played by reactive species in signal transduction, cell survival, death, human reproduction, defence mechanisms of animals and plants against pathogens, and other important biological events. The methodologies available to measure reactive species and oxidative damage (and their potential pitfalls) have been fully updated, as have the topics of phagocyte ROS production, NADPH oxidase enzymes, and toxicology. There is a detailed and critical evaluation of the role of free radicals and other reactive species in human diseases, especially cancer, cardiovascular, chronic inflammatory and neurodegenerative diseases. New aspects of ageing are discussed in the context of the free radical theory of ageing. This book is recommended as a comprehensive introduction to the field for students, educators, clinicians, and researchers. It will also be an invaluable companion to all those interested in the role of free radicals in the life and biomedical sciences.

Stem cell therapy is ushering in a new era of medicine in which we will be able to repair human organs and tissue at their most fundamental level- that of the cell. The power of stem cells to regenerate cells of specific types, such as heart, liver, and muscle, is unique and extraordinary. In 1998 researchers learned how to isolate and culture embryonic stem cells, which are only obtainable through the destruction of human embryos. An ethical debate has raged since then about the ethics of this research, usually pitting pro-life advocates vs. those who see the great promise of curing some of humanity's most persistent diseases.
In this book Cynthia Cohen agrees that we need to work toward a consensus on the issue of how we treat the embryo. But more broadly she claims that we need to transform and expand the ethical and policy debates on stem cells (adult and embryonic). This important and much-needed book is both a primer and a means by which to understand the implications of this research. Cohen starts by introducing readers to the basic science of stem cell research, and the core ethical questions surrounding the embryo. She then expands the scope of the debate, looking at the moral questions that will crop up down the line, such as e.g. the use of therapeutic cloning to overcome the body's immune resistance to stem cells; the ethics of using animals to test stem cells; how to disentangle federal and state legal and regulatory policies in pursuit of a coherent national policy; and how to develop an ethics of stem cell research that will accommodate new techniques and controversies that we cannot even foresee now. Her final chapter develops a concrete plan for an oversight systemfor this research.
This is the first single-author book that addresses the many broad ethical and legal issues related to stem cells, and it should be of great interest to bioethicists, researchers, clinicians, philosophers, theologians, lawyers, policy makers, and general readers.

Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

Consumption was the deadliest, most common disease that mankind has faced up till now. Three billion people in Europe and North America died between the fourteenth and the end of the eighteenth century. It was a death sentence with no known cause which led to the development of unusual empirical therapies. Lucky Consumptive patients reached a Sanatorium. Sanatoria were developed to house sick patients in an environment where they stood the best chance of recovery from their illness. There was no organised healthcare system and funding for a Sanatorium depended upon provision provided by wealthy individuals, or societies. Charles Dunnell Rudd was a Cape Merchant who had made a fortune in South Africa successfully prospecting for Gold and Diamonds. His mother had died from Consumption and he wished to invest some of his money in building a Sanatorium. It had been shown that Consumptive patients survived longer if they took vigorous exercise, slept out of doors, and were nursed on higher land near to forests. Rudd anonymously purchased raised land at Northwood for this purpose. Helena (later Princess Christian) was Queen Victoria's third daughter, and had a marked social awareness, arranging charitable meals for the less fortunate. She was very hard working and became the Principal Patron for Mount Vernon Hospital, donating money and attending annual fundraising Festival Dinners. Contemporary photographs from this period show female patients walking around the grounds and occupying designated rest shelters. The male patients had a more vigorous lifestyle, working in the gardens and sleeping in their beds out of doors. Those surviving often acquired new skills which might enhance their future employment prospects. These measures greatly improved the prognosis for consumptive patients. After Koch discovered the Tubercle Bacillus effective curative anti-tuberculous therapy evolved.

'Lab USA is to comics what C-Span is to network television. If you are looking to escape into an entertaining fantasy world, this is not the comic for you. If you harbor suspicions that the powerful are committing human rights atrocities and are getting away with murder, then this collection reveals the when and where. A docucomic that reveals bad science, in the language of great art.' - Sue Coe, author of Dead Meat 'The release of Lab USA is a moment in the annals of true horror. Kevin Pyle has broken a communications barrier by making a concise and accurate visual narrative of how brutality and racism have been dressed in the respectable silk of scientific research. These illuminated documents vividly display the powerlessness of US citizens and the intellectualized arrogance of doctors.' - Bob Helms, editor of Guinea Pig Zero'Pyle's vivid documentation offers a chilling indictment of a long and despicable history of bogus science inflicted for the most part on poor and working-class people.' - Publishers WeeklyElectromagnetic mind-control, open-air biological testing in New York City subways, and clandestine dosing of citizens with psychotropic drugs are all part of America's little known, yet well-footnoted history of medical abuse. Lab USA chronicles and illuminates these and many more events through the medium of comics.Employing declassified documents, court testimony, and interviews, Lab USA contrasts objective facts with powerful images to reveal the role of language and authority in the implementation of these dark deeds.

This book is about pleasure. It's also about pain. Most important, it's about how to find the delicate balance between the two, and why now more than ever finding balance is essential.

We're living in a time of unprecedented access to high-reward, high-dopamine stimuli: drugs, food, news, gambling, shopping, gaming, texting, sexting, Facebooking, Instagramming, YouTubing, tweeting... The increased numbers, variety, and potency is staggering. The smartphone is the modern-day hypodermic needle, delivering digital dopamine 24/7 for a wired generation. As such we've all become vulnerable to compulsive overconsumption.

In Dopamine Nation, Dr. Anna Lembke, psychiatrist and author, explores the exciting new scientific discoveries that explain why the relentless pursuit of pleasure leads to pain...and what to do about it. Condensing complex neuroscience into easy-to-understand metaphors, Lembke illustrates how finding contentment and connectedness means keeping dopamine in check. The lived experiences of her patients are the gripping fabric of her narrative. Their riveting stories of suffering and redemption give us all hope for managing our consumption and transforming our lives. In essence, Dopamine Nation shows that the secret to finding balance is combining the science of desire with the wisdom of recovery.

Neurostimulation for Epilepsy: Advances, Applications and Opportunities comprehensively reviews the diverse array of neurostimulation technologies currently in use and development for the treatment of epilepsy. The book covers basic research on mechanisms of neurostimulation, technical features of various FDA-approved and investigational devices for neurostimulation, clinical applications and programming considerations of these devices, and emerging insights and research based on data derived from these devices. It provides a contemporary assessment of neurostimulation in epilepsy, one that reveals recent progress in clinical applications and outcomes, fundamental questions that remain unanswered in the field, and future directions and considerations in developing next-generation devices.

Standardizing Pharmacology: Assays and Hormones, Volume Two in the Discoveries in Pharmacology series, presents selected articles from historic discoveries that are enhanced with commentary from contemporary scholars who present discussions on the importance of each chapter, along with an updated bibliography on the subject and contributions from a Nobel Prize winner and other pioneers in pharmacology. Academic and industry researchers in pharmacology and medicine, as well as advanced students will find this series a useful teaching tool and launch to new discoveries. Sections cover key discoveries in receptor theory, pharmacological methods and the development of hormone therapy, including J. Parascandola on the development of receptor theory, R.S. Yalow on radioimmunoassay, M. van Rossum and J.T L.A. Hurkmans on bioassays, M. Tausk on androgen therapy and C. Djerassi on oral contraceptives, with commentaries from experts such as T. Hoekfelt and V.C. Jordan.

The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching.

Advances in Cancer Research, Volume 144, the latest release in this ongoing, well-regarded serial, provides invaluable information on the exciting and fast-moving field of cancer research. Chapters in this new release include Gene-Environment-Microenvironment Interactions in Melanomagenesis, PP2A and the Cell Cycle, Current Progress Defining Calcium Signals as Therapeutic Targets in Cancer Cells, and much more.

Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into ‘building blocks’ that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry.

The Epigenetics of Autoimmunity covers a topic directly related to translational epigenetics. Via epigenetic mechanisms, a number of internal and external environmental risk factors, including smoking, nutrition, viral infection and the exposure to chemicals, could exert their influence on the pathogenesis of autoimmune diseases. Such factors could impact the epigenetic mechanisms, which, in turn, build relationship with the regulation of gene expression, and eventually triggering immunologic events that result in instability of immune system. Since epigenetic aberrations are known to play a key role in a long list of human diseases, the translational significance of autoimmunity epigenetics is very high. To bridge the gap between environmental and genetic factors, over the past few years, great progress has been made in identifying detailed epigenetic mechanisms for autoimmune diseases. Furthermore, with rapid advances in technological development, high-throughput screening approaches and other novel technologies support the systematic investigations and facilitate the epigenetic identification. This book covers autoimmunity epigenetics from a disease-oriented perspective and several chapters are presented that provide advances in wide-spread disorders or diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple sclerosis (MS), type 1 diabetes (T1DM), systemic sclerosis (SSc), primary Sjoegren's syndrome (pSS) and autoimmune thyroid diseases (AITDs). These emerging epigenetic studies provide new insights into autoimmune diseases, raising great expectations among researchers and clinicians. This seminal book on this topic comprehensively covers the most recent advances in this exciting and rapidly developing new science. They might reveal not only new clinical biomarkers for diagnosis and disease progression, but also novel targets for potential epigenetic therapeutic treatment.