Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book's balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

This book focuses on the envelope of Gram-positive bacteria including its composition, the latest discoveries in the mechanisms behind its assembly, and its role in pathogenesis. Furthermore, new applications in biotechnology and vaccine development involving these bacteria are discussed in detail. This concise volume consists of eleven chapters by prominent experts in the field, which review the latest findings and current state of knowledge on a range of diverse yet interlinked aspects. This book is written for all researchers, clinicians and technicians engaged in basic or applied science projects on Gram-positive bacteria.

A highly practical guide to public health intervention development. This book has been developed to assist anyone involved with effective health promotion project design. It cuts through the complex theories and technical frameworks to provide a 6 step formula for creating effective and sustainable interventions. Key features Adopts a pragmatic approach that addresses barriers and challenges to project delivery Utilises the Six Steps in Quality Intervention Development framework - a unique model designed specifically to improve intervention planning Combines the theory and concepts behind intervention development with practical methods of delivery on the ground Includes detailed case studies that provide examples of how the six steps can be used for successful intervention design As the health needs of an increasingly globalised world continue to evolve and shift, effective planning and intervention work will only become more important. Written by leading researchers and experts who draw on a wealth of experience in the field, this book will be essential reading for any student, practitioner or policy maker requiring an understanding of practical intervention design.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Expert laboratory and clinical researchers from around the world review how to design and evaluate studies of tumor markers and examine their use in breast cancer patients. The authors cover both the major advances in sophisticated molecular methods and the state-of-the-art in conventional prognostic and predictive indicators. Among the topics discussed are the relevance of rigorous study design and guidelines for the validation studies of new biomarkers, gene expression profiling by tissue microarrays, adjuvant systemic therapy, and the use of estrogen, progesterone, and epidermal growth factor receptors as both prognostic and predictive indicators. Highlights include the evaluation of HER2 and EGFR family members, of p53, and of UPA/PAI-1; the detection of rare cells in blood and marrow; and the detection and analysis of soluble, circulating markers.

Qualitative researchers have traditionally been cautious about claiming that their work was scientific. The "right-on" schools have exaggerated this caution into an outright rejection of science as a model for their work. Science is, for them, outmoded; "an archaic form of consciousness surviving for a while yet in a degraded form" ("Tyler 1986:200"). Scientists' assertions that they are in pursuit of truth simply camouflage their own lust for power. There is no essential difference between truth and propaganda. The authors acknowledge that the boundary between science and propaganda has often been breached and some distrust of scientific claims may be healthy. They also question the claim that science creates disinterested and objective knowledge of an observer-independent world without concluding that science is impossible. The skeptics' reservations about qualitative research are based on the deep-rooted assumption among natural scientists, and some social scientists, that there is a world "out there," prior to, and independent of, their observations. This world can be known objectively in the sense that all observers will, if identically placed, see it in exactly the same way. If a suitable language were available, they would also all produce identical descriptions. From these observations they can work out the laws governing the world's operations. The authors try to resolve these contrary claims by asserting that science is a "procedural" commitment. It consists of openness to refutation, a conscientious and systematic search for contradictory evidence, and a readiness to subject one's preconceptions to critical examination. The devotion to truth as a regulative ideal is an essential difference between science and propaganda. This work is a unique and innovative defense of scientific method. "Elizabeth Murphy" is reader in sociology and social policy at the University of Nottingham, UK. "Robert Dingwall" is professor and director of the Institute for the Study of Genetics, Biorisks, and Society at the University of Nottingham, UK.

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

F. Macfarlane Burnet I have been an interested onlooker for many years at research on the biology of trace elements, particularly in its bearing on the pas toral and agricultural importance of copper, zinc, cobalt, and mo lybdenum deficiencies in the soil of various parts of Australia. More recently I have developed a rather more specific interest in the role of zinc, particularly in relation to the dominance of zinc metalloenzymes in the processes of DNA replication and repair, and its possible significance for human pathology. One area of special significance is the striking effect of zinc deficiency in the mother in producing congenital abnormalities in the fetus. The fact that several chapters in the present work are concerned with this and other aspects of zinc deficiency is, I fancy, the editors jus tification for inviting me to write this foreword. In reading several of the chpaters before publication, my main impression was of the great potential importance of the topic of trace metal biology in both its negative and positive aspects-the effects of deficiency of essential elements and the toxicity of such pollutants of the modern world as lead or mercury mainly as or ganic compounds."

This book focuses on leadership and management strategies including project management, budget planning and management, governance, building a team, and developing a strategy for successful recruitment. Many creative arts therapy researchers lack training and experience in designing and implementing large scale high impact clinical trials. This book is the first in the creative arts therapies that provides guidance on clinical trial implementation. Data management, monitoring, and intervention fidelity and development of a statistical analysis plan are outlined. Finally, the text explores development of a dissemination plan as well as how to commercialise research.

This second edition expands upon the previous volume with new and updated chapters. Auditory and Vestibular Research: Methods and Protocols, Second Edition guides readers through protocols on cell culture, tissue engineering, nanotechnology, high-throughput screening, and physiology. Chapters on physiology cover techniques that include optical coherence tomography, patch clamping, and photostimulation of caged neurotransmitters. 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, Auditory and Vestibular Research: Methods and Protocols, Second Edition aims to ensure successful results in the further study of this vital field.

In anticipation of the opening of the H. Lee Moffitt Cancer Center and Research lnstitut on the campus of the University of South Florida, an international symposium, "The First Annual H. Lee Moffitt Symposium on Cancer Biology and Therapeutics" was held in Tampa, Florida on January 20-22, 1986. In this first symposium we decided to present a broad-based series of topics dealing with the major issues in the field of cancer. These topics ranged from the biochemistry of the cancer cell to the design of antineoplastic agents, through tumor cell heterogeneity, treatment of ltuman neoplasms to immunological aspects of cancer biology and tr atment. The speakers chosen represented individuals of international acclaim who are very active in the area of cancer research and treatment. The symposium brought together scien tists/physicians from six nations including Austria, Canada, France, Hungary, West Germany, and of course, the United States. The congeniality of the participants promoted the friendly exchange of knowledge which, it is hoped, will greatly hasten the time when successful management of human cancer will become routine. Future symposia in this series will be highly focused and will deal with a single facet of this vast field of cancer research and treatment. Joseph G. Cory, Editor Andor Szentivanyi, Editor University of South Florida, 1986 V ACKNOWLEDGMENTS This volume presents the Proceedings of the H. Lee Moffitt International Syn osium on Cancer Biology and Therapeutics which was held in Tampa, Florida on January 20, 21, and 22, 1986."

This detailed volume explores the application of multiplex biomarker methods in the critical area of COVID-19 research through state-of-the-art technologies in the fields of genomics, proteomics, transcriptomics, metabolomics, and imaging. The book features a series of protocols from labs across the globe employing multiplex molecular approaches, which can be applied to accelerate progress in the research of SARS-CoV-2 and other infectious illnesses. Written for the highly successful Methods in Molecular Biology series, 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 essential, Multiplex Biomarker Techniques: Methods and Applications for COVID-19 Disease Diagnosis and Risk Stratification serves as a vital resource for researchers in the areas of virology, metabolic diseases, respiratory disorders, as well as to clinical scientists, physicians, pharmacologists, and the healthcare services.

Despite the many milestones in cystic fibrosis (CF) research, progress toward curing the disease has been slow, and it is increasingly difficult to grasp and use the already wide and still growing range of diverse methods currently employed to study CF so as to understand it in its multidisciplinary nature. Cystic Fibrosis: Diagnosis and Protocols aims to provide the CF research community and related researchers with a very wide range of high-quality experimental tools, as an easy way to grasp and use classical and novel methods applied to cystic fibrosis. Volume II: Methods and Resources to Understand Cystic Fibrosis focuses on pathophysiology, Omics approaches, and a variety of key resources recently made available for CF research. Written in the highly successful Methods in Molecular Biology (TM) 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. Comprehensive and practical, Cystic Fibrosis: Diagnosis and Protocols will provide readers with optimal working tools to address pressing questions in the best technical way, while helping all of us, as a research and clinical community, to move faster hand-in-hand toward unravelling the secrets of this challenging disorder and cure it.

As individuals age, their ability to respond to andclear pathogens and to control unwanted immune reactions declines, leading to a greater incidence of certain infectious diseases, autoimmunity and general immune dysfunctions. Most remarkably, the efficacy of vaccines is frequently decreased in elderly persons. Therefore, age-associated dysfunctions of the humoral and cellular immune responses have a strong clinical impact. Improving our understanding of the aged immune system is crucial in developing effective prevention and treatment programs that will facilitate healthy aging and improve the quality of life of the elderly population.

The aim of this volume is to summarize current knowledge on the cellular and molecular aspects of the aging immune system, with an emphasis on infectious diseases and new therapeutic approaches.

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Improving our insights into the genetic predisposition to cardiovascular disease is one of the most important challenges in our field in the next millennium, not only to unravel the cause of disease but also to improve the selection of patients for particular treatments. Nowadays, for example, subjects with a cholesterol above a particular plasma level are exposed to a cholesterol lowering regime based upon the beneficial outcome of epidemiological studies which include subjects not prone to the disease, despite a plasma cholesterol above the accepted level. Identification of the patients who are genetically predisposed to the consequences of this disorder will reduce the number of subjects unnecessarily treated and, hence, the costs of health care. Because in most cardiovascular diseases the genetic component is a consequence of more than one gene defect, only limited progress has as yet been made in identifying subjects genetically at risk. For example, in hypertension only in less than 10% of the patients the genetic defect has been identified. It has been known for quite some time that in heart and blood vessels fetal genes are as high blood pressure and upregulated or induced when they are exposed to such disorders ischemia. Little is known about the function of these genes in the cardiac and vascular adaptation to these disorders; only guesses can be made.

Learn the best new approaches from the world's leading OT educators This timely book presents the most effective, innovative approaches to teaching the next generation of occupational therapists and occupational therapy assistants. Examining both fieldwork and classroom programs, Occupational Therapy in Health Care presents tested, state-of-the-art programs from leaders in the field. Its practical approaches focus on vital issues of teaching, including professional collaboration, measuring learning outcomes, emerging trends in the field, and student development. Its practical approaches focus on vital issues of teaching and fieldwork education: interactive reasoning collaborative learning the influence of learning styles student group leadership in fieldwork developing research competencies understanding disability in context establishing community partnerships academic leadership environmental scanning regarding emerging issues

Learn the best new approaches from the world's leading OT educators This timely book presents the most effective, innovative approaches to teaching the next generation of occupational therapists and occupational therapy assistants. Examining both fieldwork and classroom programs, Occupational Therapy in Health Care presents tested, state-of-the-art programs from leaders in the field. Its practical approaches focus on vital issues of teaching, including professional collaboration, measuring learning outcomes, emerging trends in the field, and student development. Its practical approaches focus on vital issues of teaching and fieldwork education: interactive reasoning collaborative learning the influence of learning styles student group leadership in fieldwork developing research competencies understanding disability in context establishing community partnerships academic leadership environmental scanning regarding emerging issues

Do you find research challenging to read? Do you struggle to get to grips with a research paper? Understanding, critiquing and using research is a key requirement of students studying nursing and healthcare. This bookwill equip you with the skills you need to understand research and use it in your practice and academic assignments. The approach used in this book is unique: each chapter focuses on a published research paper - one you might be asked to read for a seminar or include in your academic work. In clear, straightforward language, the authors take you through each paper step by step, using it as a basis for exploring the underpinning research method or design, and how it has been reported. Key features: * Each chapter focuses on a different research method by working through a relevant research paper * Identifies the main skills you need for your course: understanding research methods and critiquing articles * Written specifically for nursing and healthcare students by experienced nursing and health care lecturers * Develops your confidence in understanding research by helping you to apply your knowledge to real research papers.

This fully revised new edition explores advances in the prevention and treatment of oral diseases. Beyond the updated chapters, the book delves into regenerative biology, gene editing and the use of CRISPR in oral biology, as well as histone acetylation and deacetylation methods, further reflecting advances in the application of molecular techniques to oral biology. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and up-to-date, Oral Biology: Molecular Techniques and Applications, Third Edition serves as an ideal basic resource not only for new researchers but also for experienced scientists wishing to expand their research platform into new areas of this vital field.

'Bad Science' hilariously exposed the tricks that quacks and journalists use to distort science, becoming a 400,000 copy bestseller. Now Ben Goldacre puts the $600bn global pharmaceutical industry under the microscope. What he reveals is a fascinating, terrifying mess. Doctors and patients need good scientific evidence to make informed decisions. But instead, companies run bad trials on their own drugs, which distort and exaggerate the benefits by design. When these trials produce unflattering results, the data is simply buried. All of this is perfectly legal. In fact, even government regulators withhold vitally important data from the people who need it most. Doctors and patient groups have stood by too, and failed to protect us. Instead, they take money and favours, in a world so fractured that medics and nurses are now educated by the drugs industry. The result: patients are harmed in huge numbers. Ben Goldacre is Britain's finest writer on the science behind medicine, and 'Bad Pharma' is the book that finally prompted Parliament to ask why all trial results aren't made publicly available - this edition has been updated with the latest news from the select committee hearings. Let the witty and indefatigable Goldacre show you how medicine went wrong, and what you can do to mend it.

Study the latest research findings by international experts!This comprehensive volume presents state-of-the-art scientific research on the therapeutic uses of cannabis and its derivatives. All too often, discussions of the potential medical uses of this substance are distorted by political considerations that have no place in a medical debate. Cannabis and Cannabinoids: Pharmacology, Toxicology, and Therapeutic Potential features fair, equitable discussion of this emerging and controversial medical topic by the world's foremost researchers.Cannabis and Cannabinoids examines the benefits, drawbacks, and side effects of medical marijuana as a treatment for various conditions and diseases. This book discusses the scientific basis for marijuana's use in cases of pain, nausea, anorexia, and cachexia. It also explores its possible benefits in glaucoma, ischemia, spastic disorders, and migraine.Cannabis and Cannabinoids examines all facets of the medical use of marijuana, including: botany history biochemistry pharmacology clinical use toxicology side effectsCannabis and Cannabinoids is a reference work that will become indispensable to physicians, psychologists, researchers, biochemists, graduate students, and interested members of the public. No other book available offers this comprehensive, even-handed look at a deeply divisive subject.

Currently, hemoglobin (Hb)-based oxygen carriers (HBOCs) are leading candidates as red blood cell substitutes. In addition, HBOCs are also potential oxygen therapeutics for treatment of patients with critical ischemic conditions due to atherosclerosis, diabetes and other conditions. This book will provide readers a comprehensive review of topics involved in the HBOC development. It focusses on current products and clinical applications as well as on emerging technologies and future prospects.

Platelet-Rich Plasma (PRP) has gained tremendous popularity in recent years as a treatment option for specialties including Orthopedics, Dentistry, Sports Medicine, Otorhinolaryngology, Neurosurgery, Ophthalmology, Urology, Vascular, Cardiothoracic and Maxillofacial Surgery, and Veterinarian Medicine. Nowadays, PRP and Stem Cell Science have added an exciting dimension to tissue repair.

This book begins by giving the reader a broad overview of current progress as well as a discussion of the technical aspects of preparation and therapeutic use of autologous PRP. It is followed by a review of platelet structure, function and major growth factors in PRP (PDGF and TGF ).The third chapter outlines the basic principles of biochemical cellular metabolism that increases the efficacy of PRP. Analogous to the preparation of soil for a garden, restoring cellular health should be the first consideration in Regenerative Medicine. Standardization of PRP preparation to clinical use still remains a challenging prospect. In this sense, a feasible strategy for studying PRP preparation is illustrated, which also allows to modulate and tailor the quality of PRP for further clinical applications.

The science behind PRP and stem cells, on tissue regeneration, cell proliferation and mesenchyme stem-cells are emphasized and reviewed. Various specific uses of PRP are described with detailed illustrations of various personal experiences mainly in orthopedic injuries, ligament and tendon repair, degenerative diseases, sports medicine, chronic wound healing as well as rehabilitation aspects in tendinopathy.

Expertly written by leading scientists in the field, this book provides for beginners and experienced readers scientific fundamentals, the state of art of PRP, specific uses and personal experiences with a practical approach and reference for current trends in use. Finally, this book paves the way for future developments."

The neurotransmitter dopamine has just celebrated its 50th birthday. The discovery of dopamine as a neuronal entity in the late 1950's and the notion that it serves in neurotransmission has been a milestone in the field of neuroscience research. This milestone marked the beginning of an era that explored the brain as an integrated collection of neuronal systems that one could distinguish on basis of neurotransmitter identities, and importantly, in which one started to be able to pinpoint the seat of brain disease. The mesodiencephalic dopaminergic (mdDA) system, previously designated as midbrain dopaminergic system, has received much attention since its discovery. The initial identification of dopamine as a neurotransmitter in the central nervous system (CNS) and its relevance to psychiatric and neurological disorders have stimulated a plethora of neurochemical, pharmacological and genetic studies into the function of dopamine neurons and their projections. In the last decade, studies on gene expression and development have further increased the knowledge of this neuronal population and have unmasked a new level of complexity. The start of the molecular dissection of the mdDA system has been marked by the cloning and characterization of Nurr1 and Pitx3. These transcription factors were shown to have a critical function during mdDA development. These initial studies have been followed by the identification of many other proteins that have a crucial function in the creation of a dopamine neuron permissive region, induction of precursors, induction of terminal differentiation and finally maintenance of the mdDA neuronal pool. In addition, work showing that the historically distinguished regions of the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA ) harbor molecularly distinct sets of neuronal groups with specific connectivity patterns has added a new layer of complexity to how mdDA neurons are generated and function in the

This book provides an overview of the history of integrative bioinformatics and the actual situation and the relevant tools. Subjects cover the essential topics, basic introductions, and latest developments; biological data integration and manipulation; modeling and simulation of networks; as well as a number of applications of integrative bioinformatics. It aims to provide basic introduction of biological information systems and guidance for the computational analysis of systems biology. This book covers a range of issues and methods that unveil a multitude of omics data integration and relevance that integrative bioinformatics has today. It contains a unique compilation of invited and selected articles from the Journal of Integrative Bioinformatics (JIB) and annual meetings of the International Symposium on Integrative Bioinformatics.