This volume describes the identification of emerging organic pollutants, mainly from industrial sources, their associated toxicological threats, and the latest green methods and biotechnological solutions to abate harmful impacts on people and the environment. The chapters present reviews on current applied toxicology research, occupational health hazards and green remedial solutions for pollution control in terrestrial and aquatic environments, with the aim of raising public awareness of these issues and providing chemists, toxicologists and environmental scientists with the knowledge to combat organic pollutants through sustainable means. Readers will learn about the multi-dimensional applications of materials and processes which harvest energy out of environmental remediation technologies, as well as the roles of biotechnology and nanotechnology in addressing high pollutant load. Specific attention is paid to technologies that draw energy through wastewater remediation, as this covers the primary means by which organic pollutants are introduced into the environment from industry and other sources. The book will be of use to pollution control boards, industry regulators, and students and researchers in the fields of biotechnology, biomedical science, hydrology and water chemistry.

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed.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.

Unique and timely volume as mRNA is a hot area of research making great strides. Covers the full-scale production systems that are needed to develop vaccines as well as elements of data needed to secure the IND approvals. Introduces a commercial-scale manufacturing process using novel techniques like the PCR, in addition to the traditional plasmid DNA. First book that offers commercial technology for developing and large-scale supply of mRNA products. Renowned author and entrepreneur in the field of drug discovery and production.

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

The feld of regenerative medicine is in its infancy state. Enthusiasm for the potential of organ regeneration lies with the potential pluripotency of stem cells to differentiate into various tissue types. This volume of Methods in Molecular Biology will focus on the use of stem cells for myocardial repair and regeneration. The emphasis of this issue will be to provide basic scientists, translational investigators, and cardiologists a means to evaluate the effcacy and safety of stem cells in a standardized fashion for myocardial regeneration. Many different cell types have been considered for myocardial repair. Adult card- myocytes are unable to survive even when transplanted into normal myocardium. The use of fetal or neonatal cardiomyocytes is not a feasible source of cells due to ethical concerns and donor availability. Therefore, the use of pluripotent stem cells has become the focus of a cell source for myocardial repair and regeneration. A variety of stem cell types have been suggested to participate in myocardial repair. This has led the investigators to search for the "optimal cell type for myocardial repair". Reliable isolation of the cell source with the ability to expand the cell population is a prerequisite. In the frst section of this book, methods for isolation of commonly used stem cells being investigated for myocardial regeneration are presented. Once a stem cell source has been selected, the stem cell needs to be tested in an app- priate animal model before being translated into clinical practice.

Congenital malformations are worldwide occurrences striking in every condition of society. These severe physical abnormalities which are present at birth and affecting every part of the body happen more often than usually realized, once in every 33 births. The most common, after heart defects, are those of the neural tube (the brain and spinal cord) which happen in as many as one in every 350 births. They have been noted as curiousities in man and beast throughout recorded history and received great attention in our time by various fields of study, for example, their faulty prenatal development by embryologists, familial patterns by geneticists, causation by environmentalists and variability by population scientists.

Attention turned much in recent years to the relation of these malformations to deficiency of a particular dietary ingredient, folic acid, a subject this book analyzes in depth. The greatest conundrum of all, which this latest matter like so much else hinges on, is the amazing fact of the tremendous, almost universal decrease in the frequency of these anomalies since early in the 20th century. The puzzle is 'What can this downward trend possibly mean?' and at bottom 'Whether it is part of a long-term cyclical pattern'. This fascinating biological phenomenon is explored in the book together with various other topics.

This book will focus on DNA and histone methylation in epigenetics and describe how it is involved in the molecular mechanisms responsible for the development of cancer. Chapters will summarize the current knowledge of the molecular basis of DNA and histone methylation and explain how it is involved in cancer, describe the features of DNA and histone methylation associated with particular types of cancer, diagnostic/therapeutic applications, and future directions of DNA and histone methylation as cancer targets.

The purpose and subject of this book is to provide a comprehensive overview of all types of phantoms used in medical imaging, therapy, nuclear medicine and health physics. For ionizing radiation, dosimetry with respect to issues of material composition, shape, and motion/position effects are all highlighted. For medical imaging, each type of technology will need specific materials and designs, and the physics and indications will be explored for each type. Health physics phantoms are concerned with some of the same issues such as material heterogeneity, but also unique issues such as organ-specific radiation dose from sources distributed in other organs. Readers will be able to use this book to select the appropriate phantom from a vendor at a clinic, to learn from as a student, to choose materials for custom phantom design, to design dynamic features, and as a reference for a variety of applications. Some of the information enclosed is found in other sources, divided especially along the three categories of imaging, therapy, and health physics. To our knowledge, even though professionally, many medical physicists need to bridge the three catagories described above.

A unique point of this book is its low threshold, textually simple and at the same time full of self-assessment opportunities. Other unique points are the succinctness of the chapters with 3 to 6 pages, the presence of entire-commands-texts of the statistical methodologies reviewed and the fact that dull scientific texts imposing an unnecessary burden on busy and jaded professionals have been left out. For readers requesting more background, theoretical and mathematical information a note section with references is in each chapter. The first edition in 2010 was the first publication of a complete overview of SPSS methodologies for medical and health statistics. Well over 100,000 copies of various chapters were sold within the first year of publication. Reasons for a rewrite were four. First, many important comments from readers urged for a rewrite. Second, SPSS has produced many updates and upgrades, with relevant novel and improved methodologies. Third, the authors felt that the chapter texts needed some improvements for better readability: chapters have now been classified according the outcome data helpful for choosing your analysis rapidly, a schematic overview of data, and explanatory graphs have been added. Fourth, current data are increasingly complex and many important methods for analysis were missing in the first edition. For that latter purpose some more advanced methods seemed unavoidable, like hierarchical loglinear methods, gamma and Tweedie regressions and random intercept analyses. In order for the contents of the book to remain covered by the title, the authors renamed the book: SPSS for Starters and 2nd Levelers. Special care was, nonetheless, taken to keep things as simple as possible, simple menu commands are given. The arithmetic is still of a no-more-than high-school level. Step-by-step analyses of different statistical methodologies are given with the help of 60 SPSS data files available through the internet. Because of the lack of time of this busy group of people, the authors have given every effort to produce a text as succinct as possible.

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.

The book presents the latest developments in clinical medicine, particularly involved with pulmonary care and diseases. Emphasis is placed on the role of childhood obesity, often a result of the ill effects of an unhealthy diet and nutritional deficits, in shaping propensity for inflammatory pathologies, allergies, immune deficiency and respiratory and cardiovascular sequelae in adult life. Oxidative damage, caused by not full well understood cellular biochemistry, when unchecked by antioxidative rescue mechanisms, takes toll on a respiratory health. The book underscores the need to consider the complexity of mutual interactions of pathophysiological processes, which calls for tailoring the management strategies depending on the subgroups which patients belong to, be it obesity, children or elderly. The chapters also tackle biological diseases with genetic underpinnings. The application of genetics to identify the molecular alterations or mutations will serve well both diagnostics and targeted optimization of treatment; the poignant exemplar being the histological subtypes of lung cancer. The book provides a source of current facts and trends in clinical research and practice.

This book discusses recent advances in the field of translational stroke research. The editors have designed the book to provide new insight into the importance of regeneration and repair mechanisms for stroke victims. The editors have brought together a talented group of international stroke researchers and clinicians to contribute to this volume, which is written for students, researchers and physicians in biotechnology, neurosciences, neurology, neuroradiology and neurosurgery. Throughout the world, stroke is still a leading cause of mortality and morbidity; there are 152,000 strokes in the United Kingdom, 62,000 in Canada, and approximately 15 million people worldwide. Large communities of stroke survivors are eagerly awaiting scientific advances in translational stroke research related to regeneration and recovery of function that would offer new therapeutics for rehabilitation and regeneration utilizing novel stem cell and molecular-based approaches. This volume will allow the reader to undersnd the future of stroke treatment from its inception in the laboratory through to clinical trial design. The reader will learn about the recent advances made in these areas related to basic and applied stroke research and their translational potential. Dr. Paul A. Lapchak is Professor of Neurology and Director of Translational Research in the Departments of Neurology & Neurosurgery at Cedars-Sinai Medical Center in Los Angeles CA, USA. Dr. Lapchak is an internationally recognized expert conducting translational drug development research for ischemic and hemorrhagic stroke. Dr. John H. Zhang is Professor of Anesthesiology, Neurosurgery, Neurology, and Physiology, and Director, Center for Neuroscience Research at Loma Linda University School of Medicine, Loma Linda, CA, USA. Dr. Zhang is an internationally recognized expert working on drug development for hemorrhagic stroke.

In recent years, inorganic polymers have attracted much attention in nano-biomedicine, in particular in the area of regenerative medicine and drug delivery. This growing interest in inorganic polymers has been further accelerated by the development of new synthetic and analytical methods in the field of nanotechnology and nanochemistry. Examples for biomedical inorganic polymers that had been proven to exhibit biomedical effects and/or have been applied in preclinical or clinical trials are polysilicate / silica glass (such as naturally formed "biosilica" and synthetic "bioglass") and inorganic polyphosphate. Some members of the mentioned biomedical inorganic polymers have already been applied e.g. as "bioglass" for bone repair and bone tissue engineering, or they are used in food processing and in dental care (inorganic polyphosphates). However, there are a number of further biological and medicinal properties of these polymers, which have been elucidated in the last few years but not yet been applied for treatment of humans. In addition to polysilicates and polyphosphate, there are a series of other inorganic polymers including polyarsenate and polyvanadate, whose biological / biomedical properties have been only marginally studied so far. Moreover, the combined application of inorganic polymers and organic polymeric molecules (formation of organic-inorganic hybrid materials) provides a variety of new materials with novel property combinations and diverse applications in nanomedicine. The planned book summarizes the present state of knowledge on a large group of inorganic polymers that had hitherto been mainly considered with regard to their chemistry but not comprehensively reviewed with respect to their potential biomedical applications.

This book aims to comprehensively review the current cell-based strategies under investigation to achieve the regeneration of human hair follicles. The unique capacity of the human hair follicle to self-renew explains why this complex "mini-organ" has always attracted so much interest as a model for researchers to study stem cell biology and regenerative medicine. The hair follicle is considered a main reservoir of cutaneous stem cells, containing several pools of epithelial, melanocyte, and mesenchymal stem cells involved in hair follicle self-regeneration and pigmentation. In addition, while some of the different follicular cell types contribute to hair shaft growth, others participate in very important interfollicular functions such as dermal remodeling, re-epithelialization after wounding, and cutaneous stem cell homeostasis. The idea of human hair follicle regeneration either "de novo" or by activating dormant miniaturized follicles is not new, yet still continues to arouse enormous interest in the pursuit of a definitive cure for baldness. In contrast to hair follicle regeneration in mice, the attempts made with human follicles have been disappointing in terms of efficiency. However, recent advances in stem cell biology-as well as the appearance of new technologies like 3D printing-have revived expectations in this field of research. This book is divided into four sections. The first part includes an overview of the strategies used in hair follicle regeneration and a historical summary of the most important achievements to date. Parts two and three comprise the main body of the book, with detailed descriptions of the cells and tissue structures involved in hair follicle regeneration, followed by an elaboration of the different therapeutic strategies, engineering techniques, and a clinician's perspective of stem cell-based therapies in hair loss treatments. Finally, the fourth part reviews the important contribution of the hair follicle in healing cutaneous wounds through the regeneration and remodeling of the dermis and epidermis after injury, as well as wound induced hair follicle neogenesis that occurs when the skin is injured.

This book discusses normal sex-related differences in lung structure and function and the role these differences play in lung disease. New research on the effects of sex hormone signaling on specific cell types of the lung has begun to reveal how these hormones may drive or prevent lung disease. Expertly written chapters examine the effects of sex hormones on normal pulmonary structure and function, hormone signaling in lung health, and specific diseases such as chronic obstructive pulmonary disease, asthma, pulmonary hypertension, and lung cancer. Gender, Sex Hormones, and Respiratory Disease: A Comprehensive Guide focuses on our current understanding and the gaps in research, with suggestions for future directions and implications for therapy. This book is a useful reference for pulmonologists and researchers and will prompt further inquiry aimed at improving overall lung health.

This volume provides a comprehensive collection of classical and cutting edge protocols and techniques to examine the normal development and physiological functions of the gastrointestinal system and to model the most common digestive diseases. The chapters focus on diverse research topics including ex vivo systems to study gastrointestinal development and functions, in vivo imaging of the gastrointestinal tract, isolation and characterization of intestinal immune cells, and animal models of gastrointestinal inflammation and cancer. The Gastrointestinal Physiology and Diseases: Methods and Protocols book targets wide audience of physiologists, cell and developmental biologists, immunologists, and physician-scientists working in the field of gastroenterology and beyond. 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. Highly practical and clearly written, Gastrointestinal Physiology and Diseases: Methods and Protocols will serve both seasoned researchers as well as newcomers to the field and will provide a unique resource and expert guidance to modern laboratory techniques developed for examining normal functions and diseases of the gastrointestinal tract.

This invaluable volume serves as a guide to up-to-the-minute techniques for the discovery and evaluation of pharmacologically active compounds for therapeutic development. Focusing on practical applications, provided by expert practitioners from both industry and academic research laboratories, Advances in Drug Discovery Techniques covers rational drug design, high-throughput screening and genetic approaches to drug discovery. Moreover, chapters also focus on advances in the use of combinatorial chemistry and natural products, both of which support the chemical diversity for many drug screening programmes. Typical screening studies and their link to robotics and informatics are also presented in detail, together with an overview of current progress within antisense therapeutics. Overall, this book will be an excellent reference source for all individuals interested in making sense of the rapid changes in drug discovery that result from developments in molecular biology, robotics and informatics.

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.

The impairment of lung function caused by environmental exposure to pollutants and toxicants is a rising health problem, particularly in highly industrialized parts of the world. The problem is urgently calling for the development of new methodologies to assess both the level of elemental exposure and the effects for quality of health and longevity. This volume provides state-of-the-art information about the recent advances in occupational and non-occupational pollutant-related disorders of the respiratory tract, and the assessment of a threat they pose for the health-span. Heavy traffic-related air pollution, unnoticeable but salient health detriment, is dealt with at length.

The Eighth Annual Research Conference of the American Institute for Cancer Research, held in Washington, D.C., September 3-4, 1998, was on the subject "Colon Cancer Prevention: Dietary Modulation of Cellular and Molecular Mechanisms," with participants representing various disciplines interested in this area. One of the speak ers provided an appropriate quote from 17th century physician Thomas Adams: "Pre vention is better than healing because it saves the labor of being sick," which aptly describes the need for the prevention of cancer. An overview of normal and abnormal colonic development emphasized that although the typical human colon undergoes 1013 cell divisions by age 60, with the asso ciated possibilities for error, relatively few colon tumors develop. Since dietary modu lation leads to extremely small changes in colonic cells over a long period, animal models are useful to time, observe, and delineate the events associated with colon cancer. In the development colon cancer, the inactivation of the adenomatous polyposis coli (Apc) gene is one of the earliest known events. Normally Apc downregulates the cellular protein beta-catenin, but this is lost during cancer development. Beta-catenin may itself be an oncogene; it has a short half-life, but it is stabilized by binding to is more prevalent in the cell nucleus, the gene shuttles caherin. Although the Apc between the nucleus and the cytoplasm."

Grapevine is one of the most widely cultivated plant species worldwide. With the publication of the grapevine genome sequence in 2007, a new horizon in grapevine research has unfolded. Thus, we felt that a new edition of Molecular Biology & Biotechnology of the Grapevine could expand on all the latest scientific developments. In this edition and with the aid of 73 scientists from 15 countries, ten chapters describe new aspects of Grapevine Molecular Physiology and Biotechnology and eleven chapters have been revised and updated.

This book is intended to be a reference book for researchers, scientists and biotechnological companies, who want to be updated in viticultural research, but also it can be used as a textbook for graduate and undergraduate students, who are interested in the Molecular Biology and Biotechnology of Plants with an emphasis on the Grapevine.

In this book the results of current multidisciplinary research on different aspects of spine deformities as the etiology, the pathogenesis, the pathomechanism, the three-dimensional imaging of the spine and back, the biomechanics and kinematics of the normal and deformed spine, as well as the conservative and surgical treatment of these conditions are presented by world's most prominent researchers in the different fields of the topic.

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.

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.