* Innovative clinical trial design * Regulatory approval * Real world evidence

Essentials from the series "Applied Scanning Probe Methods" are put together in the area of bio and biorelated systems. The contributions spread over all 13 volumes are now combined in this one volume. Thus, the reader will easily find a comprehensive overview of SPM applications for biosystems.

For scientists and professionals in academic and industry dealing with surface analytics of plant science, living cells, nanomedicine, cosmetics and biomimetics.

This book, which is the third volume of Biomedical translational research, focuses on the fundamental role of biomedical research in developing new medicinal products. It emphasizes the importance of understanding biological and pathophysiological mechanisms underlying the disease to discover and develop new biological agents. The book uniquely explores the genomic computational integrative approach for drug repositioning. Further, it discusses the health benefits of nutraceuticals and their application in human diseases. Further, the book comprehensively reviews different computational approaches that employ GWAS data to guide drug repositioning. Finally, it summarizes the major challenges in drug development and the strategies for the rational design of the next generation more effective but less toxic therapeutic agents.

This book describes the discovery of molecules from unexploited extreme marine environments, and presents new approaches in marine genomics. It combines the current state of knowledge in marine genomics and advanced natural products' chemistry to pursue the sustainable production of novel secondary metabolites (lead compounds), as well as pharmacologically active peptides/proteins, with antimicrobial, neuroprotective, anti-osteoporotic, anti-protozoan/anti-plasmodial, anti-ageing and immune-modulating effects. Further, it employs molecular-biology-based approaches and advanced chemical techniques to obtain and to select candidate compounds for pre-clinical and clinical studies.

This detailed book explores methods to isolate, characterize, and investigate key lung innate immune cells. Beginning with an overview, the volume then continues with methods for creating in vitro and in vivo model systems to study inflammatory lung diseases. Written in the highly successful Methods in Molecular Biology series format, 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 cutting-edge, Lung Innate Immunity and Inflammation: Methods and Protocols aims to be a guidebook and will be of value and interest to researchers investigating innate immunity and inflammation in the lung as well as other organs and tissues.

This volume collects essays by the late bioethicist John D. Arras, best known for his many contributions to the methodology of bioethics. Always open-minded, Arras did not favor a single theory or view of method in bioethics, eschewing labels such as "casuist" or "pragmatist." He was conversant with the main philosophical methods that have dominated bioethics since the field's origin, including principlism, Gert's common morality, the "new casuistry", pragmatism, and others. Rather than defending any particular theory or method, though, Arras rigorously investigated those methods - and how they both expand and limit our field of vision. He sought, in the tradition of Kierkegaard, to make life "harder" for bioethics, by uncovering challenges to the field's analytical methods. His favorite mode of exploration and expression was the thoughtful essay. The essays collected here reveal him thinking through new problems and new possibilities, and they invariably yield fresh and valuable insights.

This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed.This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions. Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Discusses siRNA, mRNA, and plasmid manufacturing. Describes the importance of supplier-sponsor synergies on the path to commercialization. Diverse audience with a large number of individuals in the core technologies and supportive practices.

This book advocates the importance and value of errors for the progress of scientific research! Hans Kricheldorf explains that most of the great scientific achievements are based on an iterative process (an 'innate self-healing mechanism'): errors are committed, being checked over and over again, through which finally new findings and knowledge can arise. New ideas are often first confronted with refusal. This is so not only in real life, but also in scientific and medical research. The author outlines in this book how great ideas had to ripen over time before winning recognition and being accepted. The book showcases in an entertaining way, but without schadenfreude, that even some of the most famous discoverers may appear in completely different light, when regarding errors they have committed in their work. This book is divided into two parts. The first part creates a fundament for the discussion and understanding by introducing important concepts, terms and definitions, such as (natural) sciences and scientific research, laws of nature, paradigm shift, and progress (in science). It compares natural sciences with other scientific disciplines, such as historical research or sociology, and examines the question if scientific research can generate knowledge of permanent validity. The second part contains a collection of famous fallacies and errors from medicine, biology, chemistry, physics and geology, and how they were corrected. Readers will be astonished and intrigued what meanders had to be explored in some cases before scientists realized facts, which are today's standard and state-of-the-art of science and technology. This is an entertaining and amusing, but also highly informative book not only for scientists and specialists, but for everybody interested in science, research, their progress, and their history!

Respiratory diseases are leading causes of death and disability globally, with about 65 million people suffering from COPD, and 334 million from asthma, the most common chronic disease. Each year, tens of millions of people develop and can die from from respiratory infections such as pneumonia and TB. Systemic inflammation may induce and exacerbate local inflammatory diseases in the lungs, and local inflammation can in turn cause systemic inflammation. There is increasing evidence of the coexistence of systemic and local inflammation in patients suffering from asthma, COPD, and other lung diseases, and the co-morbidity of two or more local inflammatory diseases often occurs. For example, rheumatoid arthritis frequently occurs together with, and promotes the development of, pulmonary hypertension. This co-morbidity significantly impacts quality of life, and can result in death for those affected. Current treatment options for lung disease are neither effective, nor condition-specific; there is a desperate need for novel therapeutics in the field. Additionally, the molecular and physiological significance of most major lung diseases is not well understood, which further impedes development of new treatments, especially in the case of coexistent lung diseases with other inflammatory diseases. Great progress has been made in recent years in many areas of the field, particularly in understanding the molecular geneses, regulatory mechanisms, signalling pathways, and cellular processes within lung disease, as well as basic and clinical technology, drug discovery, diagnoses, treatment options, and predictive prognoses. This is the first text to aggregate these developments. In two comprehensive volumes, experts from all over the world present state-of-the-art advances in the study of lung inflammation in health and disease. Contributing authors cover well-known as well as emerging topics in basic, translational, and clinical research, with the aim of providing researchers, clinicians, professionals, and students with new perspectives and concepts. The editors hope these books will also help to direct future research in lung disease and other inflammatory diseases, and result in the development of novel therapeutics.

This volume takes an in-depth look at the potential pharmacological applications of 11 important antidiabetic plants, examining their antihyperglycemic, hypoglycemic, and anti-lipidemic properties along with current genome editing research perspectives. Plant natural products, or phytoconstituents, are promising candidates for antidiabetic pharmacological actions. The phytoconstituents, such as i' avonoids, terpenoids, saponins, carotenoids, alkaloids and glycosides, play vital roles in the current and future potent antidiabetic drug development programs Each chapter reviews a particular plant with antidiabetic properties, explaining the therapeutic aspects, its active antidiabetic compounds, and relevant genome editing technology. The specific plants discussed include Azadirachta indica (commonly known as neem, nimtree or Indian lilac), Gymnema sylvestre (commonly called gymnema, Australian cowplant, and Periploca of the woods), Syzygium cumini (commonly known as Malabar plum, Java plum, black plum, jamun or jambolana), Ceylon cinnamon (or true cinnamon, as opposed to cassia cinnamon), insulin plant (or Costus pictus), Trigonella foenum-graecum (better known as fenugreek), Mulberry, Nigella sativa L. (black caraway, also known as black cumin, nigella, kalojeera, kalonji or kalanji), Aegle marmelos (L.) (commonly known as bael (or bili or bhel), also Bengal quince, golden apple, Japanese bitter orange, stone apple or wood apple), Ficus benghalensis (the banyan, banyan fig and Indian banyan), and of course, garlic (Allium sativum). Antidiabetic Plants for Drug Discovery: Pharmacology, Secondary Metabolite Profiling, and Ingredients with Insulin Mimetic Activity will serve as a valuable source of information for students, drug researchers, medical practitioners, diabetic patients, and many others in the effort to gain understand of how these plant drug molecules can help fight diabetes.

This volume explores experimental approaches used to study Duchenne muscular dystrophy (DMD), an X-linked degenerative skeletal muscle disease caused by mutations in the dystrophin gene. Including the latest progress and scientific achievements, the book covers recent discoveries achieved through in vivo gene editing which have proven to be promising in restoring dystrophin expression, at least in ameliorating skeletal muscle symptoms, and the contents focus on "Omics" techniques in gene expression, protein expression, miRNAs, and long non-coding RNA analysis, as well as experimental studies of the structural/functional changes affecting the skeletal and cardiac muscles and ongoing preclinical studies and clinical trials. Written in the highly successful Methods in Molecular Biology series format, 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 practical, Duchenne Muscular Dystrophy: Methods and Protocols serves as a guide for researchers exploring the complicated nature of dystrophin in the hope of helping the victims of this disorder.

Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions. Features Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development. Provides the most up-to-date and best practices, techniques, and methodologies in project management. Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process. Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.

The essays in Where's the Evidence? focus on problems ignored. This book is a unique collection of critical andw controversial essays on intractable ethical issues and evidence-based problems in modern medicine. Most, but notr therapeutic disasters. Although it is impossible to prevent all missteps in medicine, the author argues, a hedging strategy using concurrent controls when new therapies are introduced always reduces the number of patients killed or injured. It is dangerous to use treatments widely, he warns, before they are subject to rigorous comparative trials. Additionally, the author points out, questions have emerged about how to wield medicine's new capabilities wisely. How do we draw the line,' he asks 'between "knowing" (the acquisition of new medical information) and "doing" (the application of that new knowledge). What are the long- term consequences (moral, social, economic, and biological) of responding to a demand that medicine always do everything that can be done?' This book now issued in paperback is a collection of critical and controversial essays discussing intractable ethical issues and evidence-based problems in modern medicine. The essays together with responses were published over a ten-year period in the journal Paediatric and Perinatal Medicine. Most of the examples, but not all are taken from perinatal medicine, the field in which the author has worked for many years. The essays are thought provoking and will be of great interest to those involved in the ongoing evidence-based medicine debate. (See selected reviews)

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is easy to donate blood or even organs, but it is virtually impossible to donate one's own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes.

Precision Medicine in Neurodegenerative Disorders, Part One, Volume 192 deals with the "Why" in the approach to slow the progression of those suffering from diseases of accelerated brain aging. Matching a biology-correcting therapy with those biologically suitable to benefit from such therapy represents the vision and mission of precision medicine, the highest level of personalized medicine. This first Handbook of Clinical Neurology volume is intended to provide a scholarly background on the framework, basic science, and conceptual pitfalls related to disease-modifying efforts in Parkinson, Alzheimer, and other neurodegenerative disorders. Among the topics covered are the different models of precision medicine, the lumping-versus-splitting tension in biomarker development and therapeutics, and the rationale for replacing the convergence of the prevailing autopsy-based nosology of neurodegenerative diseases with the divergence of a systems biology approach to human diseases. Specific chapters are dedicated to the promise of genetic subtypes and the lessons in disease modification offered by the fields of oncology and cystic fibrosis that can be adapted to the field of neurodegeneration.

This book gives insight into the functional role of non-coding RNAs in central pathways contributing to the development of obesity, type 2 diabetes, non-alcoholic fatty liver disease, atherosclerosis, myocardial infarction, cardiomyopathy, and heart failure. It also sheds light on the relationship of this cluster with cancer. Tumor cells, in contrast to cells in cardiometabolic tissues, can regulate this cluster of non-coding RNAs to escape from oxidative stress and anti-tumor immunity and maintain insulin sensitivity, facilitating cancer progression. The book presents a cluster of non-coding RNAs that may be prospectively analyzed in extensive cohort studies to determine their value in risk-predicting machine learning algorithms. In addition, it emphasizes the role of microvesicles in communication between tumor-adjacent tissue, inflammatory cells, and tumor cells, with a special focus on the role of miR-155. The book intends to promote interdisciplinary research. Due to the comprehensive background information provided in each chapter, it is suitable for researchers in academia and industry and for graduate students in biology, bioengineering, and medicine.

This multi-chapter book focuses on one of the hottest topics in ageing research - the role of hormones in health and longevity, offering a comprehensive and up-to-date overview of their mechanistic roles in health, ageing and longevity. Hormones are an excellent system of communication between cells and tissues within an organism, and they coordinate a wide range of processes in biological systems, including neuroendocrine and immunological controls. The book offers insights into the latest significant advances in our understanding of the mechanisms of hormonal signaling that control a variety of processes involved in development and ageing. It is divided into four parts: Part I includes a review of the hundred-year history of hormones by the illustrious hormone biochemist Dr. J.R. Tata. Part II presents various chapters on the hormones involved in growth, stress and metabolism, while Part III addresses the hormones controlling cognition and rhythms in ageing processes. Lastly, Part IV discusses the hormones affecting reproduction, immunity and life span. It also explores the use of hormones as pharmaceuticals to maintain health in the elderly. It is a valuable resource for those working in the area of hormone signaling in general and in the field of ageing research in particular.

The book presents the latest advances in research into health effects of air pollution, with heavy motor vehicle traffic or cigarette smoke as the exemplar of pollution. The airways are the first-line defense system against pollution. The book focuses on respiratory ailments underlain by inflammation, increased susceptibility to infection, particularly acquired during harsh environmental conditions and exposures to particulate matter or pathogens. The importance of astute analysis of lung function for early diagnosis of disorders is underscored. A knowledge deficit concerning the aerosolized drug delivery through the airways also is addressed. Recent developments and viewpoints in the field of environmental health hazards as well as methodological advances in their assessment are provided. The book will be of interest to pulmonologists, healthcare providers, researchers and clinicians engaged in environment-related respiratory diseases, but also to policy makers concerned with clean ambient air quality.

In this monograph, the author -Head researcher at the Institute of Cell Biophysics of Russian Academy of Sciences- discusses the results of his own long-term studies of mitochondria as well as alternative points of view and experiments of other important researchers in the field. The monograph contains the main aspects of mitochondrial research by a number of physical methods: fluorescence spectroscopy, UV-vis spectrophotometry, IR spectroscopy, light-scattering, optical microscopy, fluorescence microscopy, colorimetry, photobleaching, polarography, among others. The monograph is very useful for researchers and graduate students specializing in mitochondrial biophysics, biochemistry, molecular biology and cytology. The book was published in Russian in 2019 by Photon Publishers (Pushchino, Moscow region).

This book is a compendium of articles providing insights into a range of contemporary ideas concerning the core yet unsettled clinical issues. Important aspects of pulmonary disorders are tackled such as occupational respiratory health hazards, asthma, or the role of vitamin D in obstructive airway diseases. Genotyping offers a clear promise in the diagnostics of chronic pulmonary lesions of autoimmune background. Cardiac and respiratory-driven pulsation of cerebrospinal fluid content offers novel arguments in the pathophysiologic savvy of a range of brain dysfunctional conditions, including respiratory-related hypoxic pathologies. Some other articles tackle the heady topics of rehabilitation medicine, offering an insight into research-underpinned diagnostics and practical management solutions in a range of musculoskeletal disorders and injuries that affect the human body's movement, particularly those controlled by the autonomic nervous system. The book is addressed to clinicians, researchers, physiotherapists, and medical professionals engaged in patient care.

Covering all major arthropods of medical importance worldwide, this award-winning resource has established itself as a standard reference for almost 25 years. With the globilization of commerce and the world becoming more intimately connected through the everyday ease of travel, unknown arthropod species are being increasingly encountered. This means access to up-to-date, authoritative information in medical entomology has never been more important. Now in its seventh edition, this book maintains its well-acclaimed status as the ultimate easy-to-use guide to identify disease-carrying arthropods, the common signs and symptoms of vector-borne diseases, and the current recommended procedures for treatment. Includes an in-depth chapter with diagnostic aids to help physicians to recognize and accurately diagnose arthropod-related diseases and conditions more easily Updates all chapters with the latest medical and scientific findings, including Zika virus, red meat allergy, new viruses found in ticks, and vaccine development for malaria and dengue fever Presents a greater medical parasitology emphasis throughout Offers electronic downloads containing additional photographs of arthropod-caused diseases and lesions, as well as instructional videos with pest identification aids, basic entomology, and insect and pest ecology. Illustrated throughout with detailed color images to aid identification, The Goddard Guide to Arthropods of Medical Importance, Seventh Edition will remain an essential guide for physicians, public health officials, and pest control professionals.

This volume reviews disparities in cancer genetics, etiology, treatment and survivorship that are associated with differences in energy balance and how those differences and disparities may be affected by geography, socioeconomic status, ethnicity, biology, behavior and others. State-of-the-art strategies are outlined to alter these problems at the individual, community and policy levels. The book provides a comprehensive assessment of the multiple contributions of disparities in energy balance and how they affect cancer. this volume should constitute a valuable resource to disparity focused investigators at all levels and serves an important guide to professionals that deal with these issues, especially those who determine and implement policy."

MILS-13 provides an up-to-date review on the relationships between essential metals and human diseases, covering 13 metals and 3 metalloids: The bulk metals sodium, potassium, magnesium, and calcium, plus the trace elements manganese, iron, cobalt, copper, zinc, molybdenum, and selenium, all of which are essential for life. Also covered are chromium, vanadium, nickel, silicon, and arsenic, which have been proposed as being essential for humans in the 2nd half of the last century. However, if at all, they are needed only in ultra-trace amounts, and because of their prevalence in the environment, it has been difficult to prove whether or not they are required. In any case, all these elements are toxic in higher concentrations and therefore, transport and cellular concentrations of at least the essential ones, are tightly controlled; hence, their homeostasis and role for life, including deficiency or overload, and their links to illnesses, including cancer and neurological disorders, are thoroughly discussed. Indeed, it is an old wisdom that metals are indispensable for life. Therefore, Volume 13 provides in an authoritative and timely manner in 16 stimulating chapters, written by 29 internationally recognized experts from 7 nations, and supported by more than 2750 references, and over 20 tables and 80 illustrations, many in color, a most up-to-date view on the vibrant research area of the Interrelations between Essential Metal Ions and Human Diseases.

Despite extensive physiological, biochemical, and structural studies, the mechanisms of muscle contraction operating in living muscle fibres are still not clearly understood. This book aims to describe and assess various experimental methods currently used in the field of muscle research. For
each method discussed, there is a comprehensive description of its advantages, problems, and limitations. Each chapter also contains a summary of the central results to have been obtained using each method. Comprehensively written by experts in their respective fields, this book will be of interest
to all investigators in muscle physiology.