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.

Developments in the area of biomaterials, bionanotechnology, tissue engineering, and medical devices are becoming the core of health care. Almost all medical specialties involve the use of biomaterials, and research plays a key role in the development of new and improved treatment modalities. This volume focuses on several current trends in tissue engineering, remodelling and regeneration. Leading researchers describe the use of nanomaterials to create new functionalities when interfaced with biological molecules or structures. In addition to coverage of basic science and engineering aspects, a range of applications in bionanotechnology are presented, including diagnostic devices, contrast agents, analytical tools, physical therapy applications, and vehicles for targeted drug delivery. The use of polymers, alloys, and composites, or a combination of these, for biomaterials applications in orthopaedics is also explored. These contributions represent essential reading for the biomaterials and biomedical engineering communities, and can serve as instructional course lectures targeted at graduate and post-graduate students.

This book provides a comprehensive overview of the role of neuroglia in neurodegenerative diseases. Neuroglia are the most abundant cells in the nervous system and consist of several distinct cell types, such as astrocytes, oligodendrocytes,and microglia. Accumulating evidence suggests that neuroglia participate in the neurodegenerative process, and as such are essential players in a variety of diseases, including Alzheimer's, Parkinson's, and Huntington's. Intended for researchers and students, the book presents recent advances concerning the biology of neuroglia as well as their interaction with neurons during disease progression. In addition, to highlight the function of neuroglia in different types of neurodegenerative disease, it also discusses their mechanisms and effects on protecting or damaging neurons.

This book discusses the unique ion channels and transporters found within the epithelial tissues of various organs, including the kidney, intestine, pancreas and respiratory tract. Authors focus on demonstrating the crucial roles that each of these channels and transporters play in transepithelial ion and fluid transport across epithelia, as well as in maintaining homeostasis. It allows readers to gain an understanding of the fundamentals of ion transport, in terms of function, modelling, regulation, trafficking, structure and pharmacology. This is the second of three volumes highlighting the importance of epithelial ion channels and transporters in basic physiology and pathophysiology of human diseases. This volume focuses on a wide array of epithelial tissues and the use of organoids to study epithelial function. Furthermore, clinical researchers and basic scientists from various fields provide a medical perspective on the physiology of a number of tissues and organs of the body including the pancreas, intestine, sweat glands, mammary gland, inner ear epithelia, retinal pigment epithelia of the eye, choroid plexus, and the ectodermal epithelia in dental enamel formation. This volume aims to 'round out' the reader's journey from basic science to the laboratory bench and clinical management of molecular diseases, making Volume 2 a must-read for students and scientists in the field of physiology, as well as for clinicians.

-Integration of Systems Biology with Bioprocess Engineering: L-Threonine Production by Systems Metabolic Engineering of Escherichia Coli, By Sang Yup Lee and Jin Hwan Park; -Analysis and Engineering of Metabolic Pathway Fluxes in Corynebacterium glutamicum, By Christoph Wittmann; -Systems Biology of Industrial Microorganisms, Marta Papini, Margarita Salazar, and Jens Nielsen; -De Novo Metabolic Engineering and the Promise of Synthetic DNA, By Daniel Klein-Marcuschamer, Vikramaditya G. Yadav, Adel Ghaderi, and Gregory N. Stephanopoulos; -Systems Biology of Recombinant Protein Production in Bacillus megaterium, Rebekka Biedendieck, Boyke Bunk, Tobias Furich, Ezequiel Franco-Lara, Martina Jahn, and Dieter Jahn; -Extending Synthetic Routes for Oligosaccharides by Enzyme, Substrate and Reaction Engineering; By Jurgen Seibel, Hans-Joachim Jordening, and Klaus Buchholz; -Regeneration of Nicotinamide Coenzymes: Principles and Applications for the Synthesis of Chiral Compounds; By Andrea Weckbecker, Harald Groger, and Werner Hummel;

Reflecting over three decades of advances, "Epidermal Cells: Methods and Protocols, Third Edition" underscores these advances in our understanding of epidermal biology with updated and entirely new protocols that compliment and extend the earlier edition. The inclusion of protocols useful for both in vitro and in vivo studies reflects many useful developments in the field. 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.

Dependable and easy to follow, "Epidermal Cells: Methods and Protocols, Third Edition" serves researchers working to accelerate the work in this vital field of study.

If you are working in a time-sensitive context, need to deliver research findings so they can be used to inform decisions, or are finding it difficult to access research funding for long-term qualitative research, this book will help you. Introducing 'rapid qualitative research', it demonstrates how you can conduct high quality qualitative research within time, access and resource constraints. The book uses real world examples to illustrate the benefits and challenges of using rapid qualitative research designs. Focusing on the when, why and how, it explains the difference between cutting corners and making quick, well-informed research choices that support rigorous, credible research. Key features of the book include discussion questions and exercises for you to reflect on and apply your learning, as well as two case study chapters of real-world research so you can see rapid research in action. Written by the world's leading expert on this subject, this book contains the theoretical and practical nuts and bolts you need to reframe existing qualitative methods, speed up your research, and make tangible contributions to your field. It is the perfect companion for any researcher, final-year undergraduate or postgraduate student looking to conduct rapid, but rigorous, qualitative research.

Inside this book are reflections on the nature of vision and blindness. Further, there are explorations of interpretive research, and presentations of some seminal and contemporary publications in the field of blindness. The other major fodder for conversation with you the reader is an elaborated example of empirical research entitled Blind Online Learners. Each element of this inquiry is explicitly reflected upon as an example of interpretive research. This book is intended for four intersecting groups of readers. If you are a philosopher, closet or sanctioned, then you cannot ponder the nature of being without due consideration for vision, and cannot contemplate the role of seeing in our lives without listening to the stories of those who are blind. The tales within this text are particularly contemporaneous because they are contextualized by the cyber-phenomena of online learning. This segues to the second group of readers, as the described empirical research was originally intended to bring greater depth and breadth of understanding to the field of educational technology, particularly as it intersects with disability studies. There is a paucity of published literature that has inquired into disabled online learners, and this research study responds to that call. Third, this book may be used as a textbook on approaches to interpretive empirical research. It is as close as one may come to a recipe, walking students through a specific example. Because it is situated in actual empirical research, the intention was that it avoid the trap of being prescriptive or formulaic. Finally, the text is intended for readers interested in the field of blindness. The text reviews some of the seminal and contemporary research on blindness, and then presents an elaborated example of what we can and should expect to emerge in the knowledge production industry, changing what it means to be blind.

Reviewing the topic from antiquity to the present day, this book examines the debate over the use of animals in research in a fair and balanced way. The debate over the use of nonhuman animals in experimental research has gone on for centuries, and it continues as vigorously today as it ever has. In fact, in the last decade, the controversy has intensified, making animal testing a topic at the highest level of debate of any socioscientific issue in the United States. This book presents all sides of the issue so that readers can come to their own conclusions as to the morality and validity of animal experimentation, and provides biographies of individuals and descriptions of organizations that have been involved in the debate over the centuries. Additionally, it documents the historical shift in thinking that made animal experimentation commonplace between the time of the ancient Greeks and the 19th century, to the mindset of some who argue for an end to the practice and alternative ways of conducting medical experimentation to benefit human health. Presents an introduction to the history of scientific research utilizing animals and a thorough review of current issues relating to animal experimentation Provides perspectives in which stakeholders in the field outline and explain their personal views on animal testing Supplies an extensive annotated bibliography of books, articles, reports, and online resources Includes profiles of important individuals and organizations Provides an outstanding resource for secondary school students, undergraduates, or general readers with an interest in medical and biological research or animal welfare

Incidence and mortality of atherosclerosis and coronary heart disease (CHD) vary considerably among races, populations and ethnic groups. Some individuals with low levels of risk factors succumb early to disease while many others with a high risk profile do not. CHD clusters in families and is manyfold increased in first degree relatives of persons with an early onset of the disease. Such studies provide compelling evidence of the high degree of heritability of CHD and its risk factors. This book consolidates the available evidence for the roles of genetics in atherosclerosis, its correlates and its sequelae. It presents and discusses the methodology currently used to elucidate the role of genetics. Separate parts focus on evidence of familial aggregation and ethnic variability of the disease and on monogenic and polygenic inheritance modes including all the recent findings and innovation. The book also contains chapters on the genetic aspects of vessel wall processes, such as early structural findings in histological studies and the variability of coronary anatomic patterns. Polymorphisms at the DNA level (RFLP) are detailed and reviewed. Directions for future research in the exciting and fast developing realm of genetic epidemiology are outlined and the major preventive and public health implications are discussed. Genetic Factors in Coronary Heart Disease provides a systematic review of findings, integrated to offer a comprehensive summary and stepping stone for future research. It will be of interest to investigators in atherosclerosis, genetics, epidemiology, biostatistics, cardiology and public health.

This book systematically summarizes the ideas and technologies used in urine proteome analysis. It argues that change is the core of biomarker definition since the body uses its homeostatic mechanisms to correct changes in the blood. This means that urine is probably a better source of biomarkers than blood. A roadmap to the urinary biomarker era is proposed, and researchers are reminded of the potential opportunities and risks in their study design. Kidney diseases are emphasized as they produce the most significant changes in urine. This book tries to show researchers and graduate students, who are in or entering the field, "all things considered" rather than "the current affair".

This combination manual and downloadable resources provide much-needed training on the proper handling of rats used in biomedical research. The downloadable resources include narrated video clips that demonstrate and describe each procedural technique. The manual contains handouts with color illustrations and descriptive text for each technique, including the purpose and application of the procedure, recommended skills, and necessary supplies. It can be used as a training resource and refresher for lab animal veterinarians, veterinary technicians, animal care staff, trainers, and research investigators and staff who work with rats.

By the year 2050, the world's population is expected to reach nine billion. To feed and sustain this projected population, world food production must increase by at least 50 percent on much of the same land that we farm today. To meet this staggering challenge, scientists must develop the technology required to achieve an "evergreen" revolution -- one that increases crop productivity without degrading natural resources. With 30 percent new material, the updated and revised third edition of Growth and Mineral Nutrition of Field Crops covers all aspects of crop growth and mineral nutrition that contribute to sustainable, high-yield agriculture. Bringing together international scientific knowledge of crop production and the impacts of agriculture on the environment, this book: * Includes two new chapters on remediation of heavy-metal contaminated soils and cover crops * Covers theoretical and practical aspects of mineral nutrition of field crops * Provides recommendations for judicious use of fertilizers, which will reduce cost of crop production and enhance high crop yields without risking environmental pollution * Provides growth patterns for annual crops and forages * Includes a handful of color pictures of nutrient deficiencies for easy diagnostic purposes To make the book as practical as possible, each chapter is supported by experimental results and extensive references. A large number of figures and tables are also included to save readers time when researching. The overall emphasis of this reference is on the soil's ability to sustain high crop yields and a healthy human population.

Vast therapeutic applications of the following specific stem cells in disease and tissue injury are discussed: embryonic stem cells, induced pluripotent stem cells, human hair follicle stem cells, bone marrow-derived human mesenchymal stem cells, adipose-derived stem cells, periodontal/progenitor cells, cancer stem cells, and breast cancer stem cells. Because human embryonic stem cells possess the potential to produce unlimited quantities of any human cell type, considerable focus is placed on this type of stem cells in this volume. The role of cancer stem cells, specifically in breast cancer is explained. Transplantation of mesenchymal stem cells to aid the injured brain is included. Immune recovery after stem cells transplantation in severe combined immunodeficiency patients is described. The role of mesenchymal stem cells in enhancing the growth and metastasis of colon cancer is discussed. Clinical application of human follicle stem cells is presented. Treatment of malignant gliomas using genetically-modified neural stem cells as a marker is discussed. The impact of cancer stem cell hypothesis on designing new cancer therapies is explained. In the field of regenerative medicine, the use of stem cells in the repair of the central nervous system, tendon injury, and as a cardiac regenerative medicine is described. The role of DNA methylation in maintaining stemness induced pluripotent stem cells from human extraembryonic amnion cells is discussed. Insights on the understanding of molecular pathways involved in tumor biology are explained, which lead to the development of effective drugs. Information on pathways, such as hedgehog, facilitates targeted therapies in cancer.

This book provides a concise overview of the state of the art in the biology and treatment of plasma cell malignancies, a heterogeneous group of diseases primarily characterized by the presence of clonal plasma cells within the bone marrow or extramedullary sites. The plasma cell dyscrasias investigated include monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, plasmacytoma, immunoglobulin deposition diseases (primary amyloidosis and systemic light and heavy chain deposition diseases), and Waldenstroem's macroglobulinemia. In the case of multiple myeloma, the coverage ranges from genomic aberrations and microRNAs to treatment for different patient groups, upcoming novel therapies, immunotherapy, and transplantation. The book reflects the significant research advances achieved in this field during the past few years, which have enhanced our understanding of the molecular mechanisms responsible for the pathogenesis of plasma cell dyscrasias.

Cell based impedance sensing is becoming a new biophysical and cellular technology in cell based analyses. The technology has been used in investigation of cellular growth and death, cell adhesion and migration, cell invasion and cell-cell interactions, cell toxicity, angiogenesis, cell permeability, signal transduction and cellular behaviour under flow conditions. It is a probe free, highly sensitive, and versatile technology platform. Recent development in the technology has also allowed high throughput, automated analyses. It has been widely explored in chemistry, toxicity, cell biology, cancer biology, and other areas of chemistry, medicinal chemistry, life and medical science. Written by experts in the area of cell impedance sensing, including the Nobel Laureate Dr Ivar Giaever, this books covers the background of electric cell-substrate impedance sensing, their applications in cell based investigations, particularly in the area of cancer biology. This book is the first on this technology platform and will be a highly useful reference for molecular and cell biologists, cancer biologists, chemists and biochemists, clinical researchers who work in the areas of cell biology, molecular biology, toxicology, pharmaceutical industry, life science and medical research.

Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a historical account of how each of CAPRISA's high impact studies was created, developed, implemented, analysed and communicated. In doing so, the reader is taken on a journey that provides glimpses into the genesis of research ideas and how this ultimately leads to a range of HIV prevention and treatment studies that have impacted the global response to the HIV and TB epidemics. Comprised of 5 sections, the book details the following: HIV epidemic in South Africa and the establishment of a research centre to undertake clinical, epidemiological and laboratory research on HIV. CAPRISA's clinical trials on HIV and HSV-2 prevention. These studies investigated the impact of tenofovir gel as topical antiretroviral pre-exposure prophylaxis (PrEP), implementation of topical PrEP through family planning clinics, conditional cash incentives for HIV prevention, HIV vaccines, and passive immunisation with broadly neutralising antibodies. CAPRISA's research on the treatment of HIV and TB co-infection. A review of the major scientific findings from the CAPRISA studies on acute infection and genital mucosal immunology. Essential support activities for the conduct of clinical trials, including research laboratories and pharmacies, as well as establishing effective communication and sustainable structures for community engagement to maintain effective and respectful partnerships with participating communities. The book concludes with a chapter about the challenges facing future HIV prevention and treatment trials. The CAPRISA Clinical Trials: HIV Treatment and Prevention is a resource for undergraduate and postgraduate students, health care providers, doctors, decision-makers and researchers who are seeking guidance and insights on clinical trials - their creation, conduct and impact.

"Methods in Pulmonary Research" presents a comprehensive review of methods used to study physiology and the cell biology of the lung. The book covers the entire range of techniques from those that require cell cultures to those using in vivo experimental models. Up-to-date techniques such as intravital microscopy are presented. Yet standard methods such as classical short circuit techniques used to study tracheal transport are fully covered. This book will be extremely useful for all who work in pulmonary research, yet need a practical guide to incorporate other established methods into their research programs. Thus the book will prove to be a valuable resource for cell biologists who wish to use organs in their research programs as well biological scientists who are moving their research programs into more cell related phenomena.

This book covers new techniques in protein NMR, from basic principles to state-of-the-art research. It covers a spectrum of topics ranging from a "toolbox" for how sequence-specific resonance assignments can be obtained using a suite of 2D and 3D NMR experiments and tips on how overlap problems can be overcome. Further topics include the novel applications of Overhauser dynamic nuclear polarization methods (DNP), assessing protein structure, and aspects of solid-state NMR of macroscopically aligned membrane proteins. This book is an ideal resource for students and researchers in the fields of biochemistry, chemistry, and pharmacology and NMR physics. Comprehensive and intuitively structured, this book examines protein NMR and new novel applications that include the latest technological advances. This book also has the features of: * A selection of various applications and cutting-edge advances, such as novel applications of Overhauser dynamic nuclear polarization methods (DNP) and a suite of 2D and 3D NMR experiments and tips on how overlap problems can be overcome * A pedagogical approach to the methodology * Engaging the reader and student with a clear, yet critical presentation of the applications

This book deals with the growing challenges of using assistive robots in our everyday activities along with providing intelligent assistive services. The presented applications concern mainly healthcare and wellness such as helping elderly people, assisting dependent persons, habitat monitoring in smart environments, well-being, security, etc. These applications reveal also new challenges regarding control theory, mechanical design, mechatronics, portability, acceptability, scalability, security, etc.

Mathematical Modelling in Medicine is divided into four distinct parts which cover mathematical models of heart, arterial tree, baroreceptor control and applications for simulators. The mathematical models covering these four topics are contained in a number of articles in each part. In addition, historical reviews on the heart, arterial tree and baroreceptors are also included in the articles offering a broader view and understanding of the current physiological models. The models presented are all based on fundamental physiological principles. This common guideline may result in more solid models from which we can obtain new physiological insights. Mathematical Modelling in Medicine demonstrates that the increase in popularity and success of mathematical models, is not solely a consequence of the development and spread of fast computers, making easier access to simulations of complex systems. An important element for this success is the precise continuous samplings of new clinical data have generated experiments, from which one can gain new insights into the dynamics of physiological systems and not only into their steady state behaviour patterns. Another important element is the attempts to focus on precise definitions of physiological concepts in order to avoid confusion, misunderstandings and waste of efforts. Furthermore, it is shown, that mathematics may also provide a tool to structure thoughts, an area which have gained an increasing attention lately. This book will be of interest to graduate students as well as researchers in the interdisciplinary fields of bioengeneering, biophysics and mathematical physiology.

This is the very first book to deal with sex and gender differences in drug therapy - an increasingly recognized medical need. It starts with an overview on S/G in clinical syndromes and a documentation of the medical and socioeconomic damage caused by gender specific adverse drug effects. Part I covers S/G differences in pharmacokinetics. Researchers will be satisfied by the detailed discussion of the mechanisms of S/G differences in drug effects that represents cutting edge science and includes interaction of drugs with sex hormones, genomic and epigenetic mechanisms. It also covers S/G in drug development, in animal models and clinical development and S/G in drug prescriptions. Part II targets S/G differences in drug effects in cardiovascular, pulmonary, CNS, neuromuscular, neuropsychiatric and metabolic diseases, in cancer, inflammation, and rheumatic diseases, in bacterial and retroviral infections, thrombosis, embolism. New drugs will be discussed.

During the past decade as the data on gene sequences and expression patterns rapidly accumulated, cell-free protein synthesis technology has also experienced a revolution, becoming a powerful tool for the preparation of proteins for their functional and structural analysis. In Cell-Free Protein Production: Methods and Protocols, experts in the field contribute detailed techniques, the uses of which expand deep into the studies of biochemistry, molecular biology, and biotechnology. Beginning briefly with basic methods and historical aspects, the book continues with thorough coverage of protein preparation methods, the preparation of proteins that are generally difficult to prepare in their functional forms, applications of the cell-free technologies to protein engineering, as well as some methods that are expected to constitute a part of future technologies. Written in the highly successful Methods in Molecular Biology series format, the chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and notes on troubleshooting and avoiding known pitfalls.

Authoritative and cutting-edge, Cell-Free Protein Production: Methods and Protocols aims to help researchers continue the growth of the vital exploration of cell-free sciences and technologies in order to better understand the dynamic lives of cells.

Medical science and practice have undergone fundamental changes in the last 5 years, as large-scale genome projects have resulted in the sequencing of a number of important microbial, plant and animal genomes. This book aims to combine industry standard software engineering and design principles with genomics, bioinformatics and cancer research. Rather than an exercise in learning a programming platform, the text focuses on useful analytical tools for the scientific community.