Mammalian cell lines command an effective monopoly for the production of therapeutic proteins that require post-translational modifications. This unique advantage outweighs the costs associated with mammalian cell culture, which are far grater in terms of development time and manufacturing when compared to microbial culture. The development of cell lines has undergone several advances over the years, essentially to meet the requirement to cut the time and costs associated with using such a complex hosts as production platforms.

This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout.

This book is designed to collect and review the research covering main directions in investigations of aromatic nitroso compounds in last decades, and to present both, the academic aspects of this chemistry, as well as the open field of its applicability. The book is divided in five chapters. The basic structural properties of the nitroso aromatic molecules are described in the first chapter. The second chapter is an overview of the methods of preparations of aromatic nitroso and polynitroso compounds, including classical synthetic methods and some new preparative approaches. The third part deals with the physico-chemical properties of nitroso aromates and azodioxides, its structure, crystallography, quantum chemical calculations, spectroscopy, typical reactions, and especially it is focused on the dimerizations in the solid-state. In the fourth chapter is represented organometallic chemistry of nitroso aromatic molecules and its applications in catalysis. The last part of the book deals with the behavior of this class of compounds in the biological systems, reactions with biomolecules and the use in toxicology.

Health Psychology, once subsumed under social psychology, has in recent years surpassed it to become one of the most dynamic, interesting areas in the field. One of the reasons for the rapid success of health psychology is that it provides an in-depth look at the influence of behaviour on the national obsessions of health and wellness. Health psychology has a wide scope, encompassing all influences on behaviour from emotion to overcrowded living situations. Because health psychology combines in-depth research in a variety of areas within the discipline, collaboration between these areas is especially important. Yet, health psychology faces a problem not uncommon to any highly interdisciplinary science: a lack of information on how to foster collaboration between areas. This unique volume will provide a solution to the problem of collaboration by articulating both the benefits of interdisciplinary exchange and the best strategies for working together. The contributors, including Richard Davidson, Michael Meaney, John Caccioppo, and Neil Schneiderman, have carried out the most innovative and successful collaborative research endeavors in major areas of health psychology. Their experience will provide much-needed guidance and inspiration for future collaborative research in the discipline. This volume will be of interest to researchers and students in health psychology, as well as to officers in universities, foundations, and government agencies seeking to develop programs that expand the boundaries of health psychology.

A distinguished panel of world authorities reviews the current state of today's understanding, diagnosis, and treatment of pancreatic cancer. Their cutting-edge reviews discuss both medical and surgical modalities and include numerous insights into the basic molecular processes underlying the disease. Among the key topics covered are the prospects for early diagnosis using molecular techniques, the latest diagnostic and therapeutic methods, the role of laparoscopy (diagnostic and therapeutic), and nonsurgical treatment. The reviewers also address the future possibilities for clinical advances, quality of life concerns, and the value of the Japanese "extended Whipple resection." Pancreatic Cancer will become the new standard reference for all clinicians who diagnose and treat this disease, as well as for basic scientists needing a summary of the many recent advances.
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Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

Brute Science investigates whether biomedical research using animals is, in fact, scientifically justified. Hugh LaFollette and Niall Shanks examine the issues in scientific terms using the models that scientists themselves use. They argue that we need to reassess our use of animals and, indeed, rethink the standard positions in the debate.

A cutting-edge collection of readily reproducible in vitro and in vivo methods to elucidate the mechanisms associated with cannabinoid function in health and disease. The techniques can be used in studies across the board from genes to behavior. The molecular neurobiological methods are invaluable in analyzing the structure, the polymorphisms, and the molecular expression of the cannabinoid receptors (CBrs), as well as their association with polysubstance abuse. There are also methods for localizing cannabinoid receptors in different systems, visualizing cannabinoid effects using brain slice imaging and elctrophysiological approaches, and designing and synthesizing cannabinoids and endocannabinoids. The protocols follow the successful Methods in Molecular Medicine (TM) series format, each offering step-by-step laboratory instructions, an introduction outlining the principles behind the technique, lists of the necessary equipment and reagents, and tips on troubleshooting and avoiding known pitfalls.

From the courtrooms of Nuremberg to the battlefields of the Gulf War, Undue Risk exposes a variety of government policies and specific cases, includingplutonium injections to unwilling hospital patients, and even the attempted recruitment of Nazi medical scientists bythe U.S. government after World War II.

The advent of non-invasive imaging technology, such as magnetic resonance imaging (MRI), has allowed biologists and clinicians to make great strides in unraveling the secrets of the brain. In Magnetic Resonance Neuroimaging: Methods and Protocols, expert researchers in the field provide a comprehensive collection of experimental MRI protocols that can be used to non-invasively interrogate the healthy and diseased brain. The chapters are divided into general techniques, such as the measurement of relaxivity, magnetic resonance spectroscopy, diffusion tensor imaging, and MR reporter genes, as well as specific applications in brain imaging, for example, phenotyping transgenic animals, detecting amyloid plaques, and fMRI in psychiatry. As a volume in the highly successful Methods in Molecular Biology(TM) series, this work contains the type of detailed description and implementation advice that is crucial for getting optimal results. Thorough and cutting-edge, Magnetic Resonance Neuroimaging: Methods and Protocols serves neuroscientists, clinical neurologists, psychiatrists, and radiologists with an excellent compendium of methods easily applied to both animal and human studies and certain to be an excellent resource for translational research.

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I-II Clinical Trials describes how phase I-II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

This comprehensive text examines both global and local coronary blood flow based on morphometry and mechanical properties of the coronary vasculature. Using a biomechanical approach, this book addresses coronary circulation in a quantitative manner based on models rooted in experimental data that account for the various physical determinants of coronary blood flow including myocardial-vessel interactions and various mechanisms of autoregulation. This is the first text dedicated to a distributive analysis (as opposed to lumped) and provides digital files for detailed anatomical data (e.g., diameters, lengths, node-to-node connections) of the coronary vessels. This book also provides appendices with specific mathematical formulations for the biomechanical analyses and models in the text. Written by Dr. Ghassan S. Kassab, a leader in the field of coronary biomechanics, Coronary Circulation: Anatomy, Mechanical Properties, and Biomechanics is a synthesis of seminal topics in the field and is intended for clinicians, bioengineers, and researchers as a compendium on the topic. The detailed anatomical and mechanical data provided are intended to be used as a platform to address new questions in this exciting and clinically very important research area.

Thoracic lymphadenopathy consists of mediastinal and/or hilar lymphadenopathy. Thoracic lymph nodes are anatomically one of the most complex groups of the lymphatic network in the body and describing them could be nerve wracking if there is no proper understanding of the locations, its systemic divisions and its significance in diseased states. Thoracic lymphadenopathy is one of the most common radiological findings seen on the CT scan of thorax. The incidence of these findings have particularly increased in the era of lung cancer screening with low dose CT scan of the chest. The differential diagnosis for mediastinal and hilar lymphadenopathy is broad and spans from being reactive to benign disease to lung cancer or metastatic cancer. In this book, we have tried to simplify the lymph node stations based on the latest IASLC guidelines, done a very comprehensive review about mediastinal and hilar lymphadenopathy in different disease states and provided the pathway to diagnosis. This book also gives a detailed account of noninvasive testing including CT chest and PET CTs. This book also discusses in detail the advanced endoscopic and non-endoscopic procedures like EBUS-TBNA, EUS and Mediastinoscopy that we have at our disposal for the diagnosis of thoracic lymphadenopathy. The indications, contraindications, sensitivity and specificity of each procedure is discussed in detail.

Winner of the 2008 AJN Book of the Year Award

Named an Outstanding Academic Title for 2008 by"Choice "

"This well written and well edited book fills a unique gap.... one of the] precious few books] that focus on science or medicine and one of] even fewer that cover the history of nursing."(Three Stars)--"Doody's Book Review Service"

While there have been many research texts in the nursing literature, and nursing history is both taught in courses and of popular interest to practicing nurses, there has "never" been a hands-on text that describes the process of doing historical research in nursing. This book, contributed by well-known and respected nurse historians, provides the necessary direction, guidance, and examples needed to conduct historical research. It covers such topics as historiography, biographical research, using artifacts in historical research, doing archival and other data searches, doing international historical research, and locating funding sources for historical research. Case studies will be used throughout to illustrate various methods and describe how, why, when, and where historical research is used in nursing.

Features of this edition:
Provides direction and tools for conducting historical research Describes types of research, including biographical and oral histories Covers frameworks used to study historical events, such as social, political, feminist, intellectual, and cultural Addresses contemporary issues such as preserving and storing digitalized and tape-recorded data and obtaining institutional review board (IRB) approval for research, and addressing ethical and legal issues in historical research Includes case studies that provide a "how-to" guide to conducting research

This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.

Cutting edge reviews by leading researchers illuminate key aspects of DNA repair in mammalian systems and its relationship to human genetic disease and cancer. Major topics include UV and X-Ray repair, repair of chemical damage, recombinational repair, mismatch repair, transcription-repair coupling, and the role of DNA repair in disease prevention. Extensive up-to-date references and rigorous peer-review of each chapter make this volume definitive and bring it to the active frontiers of research.

The newer research areas in pharmaceutical sciences, particularly molecular modeling and simulations, prompted a more efficient drug discovery process. Informatics integrated with pharmaceutical sciences (cheminformatics and bioinformatics) became an essential component of drug research. Drug informatics such as genomics and proteomics assists in the Rational Drug Design (RDD). This emerging discipline is known as "Computer-Aided Drug Design" (CADD), which has profound application in RDD. The advanced and adequate practice in drug design informatics is essential for pharmacy graduates. Hence, a companion for acquiring knowledge on these concepts is vital. The students of B. Pharmacy, M. Pharmacy (Pharmaceutical Chemistry, Pharmacology, and Pharmaceutics), biotechnology, biomedical engineering and other interdisciplinary fields may find this book as a reference guide. The salient features of this book are: * Systematic and simple approach * Emphasis on traditional and modern drug design strategies * Comprehensive coverage for the current advances in the drug design * Experimental section to ensure hands-on-experience Note: T& F does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka.

Cancer is one of the leading killers in the world and the incidence is increasing, but most cancer patients and cancer survivors suffer much from the disease and its conventional treatments' side effects. In the past, clinical data showed that some complementary and alternative medicine (CAM) possessed anticancer abilities, but some clinicians and scientists have queried about the scientific validity of CAM due to the lack of scientific evidence. There is great demand in the knowledge gap to explore the scientific and evidence-based knowledge of CAM in the anticancer field. With this aim, a book series is needed to structurally deliver the knowledge to readers. Integrative therapies comprise a variety of non- pharmacological interventions that assist in alleviating physical and psychological symptoms. Apart from being a life-threatening disease, cancer and its therapy are usually associated with a significant deterioration in the quality of life. There is growing evidence that non-pharmacological therapies provide symptom and pain management in cancer palliation. This volume is a specialised book presenting the research evidence relevant to the application of a range of commonly used non-pharmacological interventions in supportive cancer care, including massage, acupressure, Qigong, yoga, mind-body therapy, mindfulness-based intervention, and aromatherapy. A number of scientific researches and clinical studies support that these therapies offer potential beneficial effects for cancer patients in terms of reducing pain, anxiety, and other symptoms. Indeed, non-pharmacological therapies are increasingly gaining acceptance in the healthcare community as complementary to conventional cancer treatments. Most of them are non-invasive, inexpensive, and useful in improving quality of life, and they may be accessed by patients themselves.

Respiratory Neurobiology: Physiology and Clinical Disorders, Part Two, Volume 189 is one of two volumes on the neurology of breathing. This volume focuses on pathologies attributable to abnormalities of the neural control of breathing, breathing problems that may occur in neurological diseases, and the neurological complications of respiratory diseases, while volume one focuses on the neurophysiology of breathing.

This book provides a thought-provoking guide to conducting collaborative arts-based research. Focusing on ways that social inquiry might be conducted with marginalised groups to promote social justice, the text offers chapters on: Telling 'alternative' stories through a variety of methods from crafts to digital film Visual and metaphorical approaches to social research including photography, art and poetry Performative methods that include drama, dance, music and performance art Foster introduces relevant methodological debates, giving a context for understanding when arts-based research can be a fruitful approach to take and outlining a convincing rationale for using the arts as a way of understanding and representing the social world. The book also suggests a range of alternative criteria for evaluating the quality of arts-based research. Illustrative examples from around the world are used throughout the book and an extended case study is included that focuses on Foster's own collaborative arts-based research. With their emphasis on the value of participative research and social justice, arts-based methodologies are becoming increasingly popular in health and social research. This is the ideal text for anyone looking to introduce arts-based methods into their research practice.

Mitochondria, often referred to as the "powerhouses" of the cell, generate adenosine triphosphate (ATP) by oxidative phosphorylation or OXPHOS, and maintain cellular homeostasis. In addition to generating ATP, mitochondria are involved in regulation of cell cycle, proliferation, free radical production, innate immune responses and apoptosis. Mitochondrial Function in Lung Health and Disease fills the current gap in the literature and outlines the growing clinical relevance of mitochondrial dysfunction. Currently, there is no overview on the role of mitochondria in pulmonary diseases and this volume focuses on the mitochondrial metabolism, redox signaling, and mechanisms of mitochondrial pathways in lung injury, inflammation, repair and remodeling. Furthermore, in addition to their well-recognized role in cellular energy production and apoptosis, mitochondria appear to play a role in many respiratory diseases and lung cancer. Chapters are written by top notch researchers and clinicians and outline the evidence for mitochondrial biogenesis in inhalational lung injury, COPD and asthma.

This book brings together a collection of empirical case studies featuring a wide spectrum of medical innovation. While there is no unique pathway to successful medical innovation, recurring and distinctive features can be observed across different areas of clinical practice. This book examines why medical practice develops so unevenly across and within areas of disease, and how this relates to the underlying conditions of innovation across areas of practice. The contributions contained in this volume adopt a dynamic perspective on medical innovation based on the notion that scientific understanding, technology and clinical practice co-evolve along the co-ordinated search for solutions to medical problems. The chapters follow an historical approach to emphasise that the advancement of medical know-how is a contested, nuanced process, and that it involves a variety of knowledge bases whose evolutionary paths are rooted in the contexts in which they emerge. This book will be of interest to researchers and practitioners concerned with medical innovation, management studies and the economics of innovation. Chapter 5 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9781138860346_oachapter5.pdf

Respiratory Neurobiology: Physiology and Clinical Disorders, Part One, Volume 188 is one of two volumes on the neurology of breathing. This volume focuses on the neurophysiology of breathing, while the second volume focuses on pathologies attributable to abnormalities of the neural control of breathing, breathing problems that may occur in neurological diseases, and the neurological complications of respiratory diseases.

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

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