Contains papers from the October 1995 symposium, in sections on general aspects, transgenics, and immunology and infectious diseases. Topics include ultrastructure of the liver in piglets fed dietary oils, artificial surfactant as a vehicle for endotracheal epinephrine in pediatric porcine cardiopul

The Springer Handbook of Enzymes provides concise data on some 5,000 enzymes sufficiently well characterized and here is the second, updated edition. Their application in analytical, synthetic and biotechnology processes as well as in food industry, and for medicinal treatments is added. Data sheets are arranged in their EC-Number sequence. The new edition reflects considerable progress in enzymology: the total material has more than doubled, and the complete 2nd edition consists of 39 volumes plus Synonym Index. Starting in 2009, all newly classified enzymes are treated in Supplement Volumes."

The purpose of this book is to provide information which supports the fact that rat hybridomas are no more difficult to develop than mouse hybridomas. This is the first book devoted to the development of rat hybridomas. It includes theories, step-by-step techniques, ingredients and apparatus. The focus of this work is on the antibody repertoire, the unique biological properties of rat immunoglobulins, the one-step purification procedure by immunoaffinity chromatography, the absence of C-type particles, and the easy production of large amounts of ascitic fluid containing rat MAb. This rare publication is an absolute must for all scientists using MAbs and those interested in the fields of immunology, biotechnology, and biochemistry.

Gives a convenient summary of trials in Gynecologic Oncology Supplies an invaluable revision primer for those undertaking certification Provides a uniquely up-to-date resource

The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve advanced development with added certainty of a drug or biologic's success to senior corporate management and investors. There are numerous textbooks, reference texts and treatises on medical imaging technologies, teaching tools on medical cases and physics books on the science of detector and computer interface systems. Rarely, in each of these are examples of medical imaging protocols and animal models of disease i.e. a text on methodology in drug development is currently unavailable.

There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book's website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Research has clearly established a link between omega fatty acids and general health, particularly cardiovascular health. Omega Fatty Acids in Brain and Neurological Health, Second Edition, illustrates the importance of omega-3 fatty acids in longevity, cognitive impairment and structure and function of the brain's neurons and also the adverse effects of omega-6 fatty acids on neurological function. This book encompasses some of the most recent research on the links between omega fatty acids and the developing brain, aging, dementia, Alzheimer's disease and multiple sclerosis, including the role of omega-3 fatty acid supplements on hippocampal neurogenesis, substantia nigra modulation, migraine headaches, the developing brain in animals, sleep and neurodegenerative diseases. This completely updated second edition focuses on the counterbalancing dietary and tissue omega-6 fatty acids as well as it studies the effects in pregnancy and early infancy, animal model studies and autoimmune neurological diseases.

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.

Praise for the first edition: "Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book-not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Considerable progress has been made in neurochemical and therapeutic aspects of dementia research in recent years. Molecular and Therapeutic Aspects of Dementia presents readers with comprehensive and cutting-edge information on the neurochemical mechanisms of various types of dementias. It provides a clearly written and logically organized and comprehensive overview of molecular aspects of risk factors, symptoms, pathogenesis, biomarkers, and therapeutic strategies for various types of dementia. This book is written for the international audience of neurochemists, neuroscientists, neurologists, neuropharmacologists, and clinicians. The hope is that this discussion will not only integrate and consolidate knowledge in this field, but will jumpstart more studies on molecular mechanisms and therapeutic aspects of dementia. The comprehensive information in this monograph may not only help in early detection of various types of dementia and dementia linked neurological disorders, but also promote discovery of new drugs, which may block or delay the onset of dementia in elderly patients. Understanding the course of dementia is important not only for patients, caregivers, and health professionals, but also for health policy-makers, who have to plan for national resources needed in the management of an increasing number of dementia cases.

In this volume, the major metabolic alterations identified in cancer and tumor-associated cells are explored, including discussions of former and emerging approaches to drug development in targeting cancer cell metabolism. The metabolic network in cells promotes the generation of both energy and biomass needed for them to grow, divide and differentiate. However, the metabolism of malignant cells generally varies from that of normal cells. These differences provide a platform for the discovery of new approaches to targeting potential vulnerabilities in cancer cells for therapeutic options Some of the significant changes that occur involve ATP production and consumption that modulates the ATP to ADP ratio, hypoxia and the effects of reactive oxygen species on glycolysis, regulation of mitochondrial respiration, induction and suppression of autophagy, and the Warburg effect and "reverse" Warburg effect--these topics and more are discussed in this volume.

One week, red wine is good for the heart. The next week, new reports say it's bad for the health. So which is true? Anyone who's ever read science news with fascination, or who's ever been confounded by conflicting stories will appreciate this book. Taking a look at some true to life contemporary news stories, the author assesses recent studies on topics ranging from vitamin C and caffeine to pollution and cancer. With straight talk and a passion for the whole project of science, he demysifies the cult of the expert and sheds light on the nitty-gritty details of scientific processes. Any scientist loves a challenge, but the biggest challenge of all, observes Jenkins, is shared by scientists and nonscientitsts alike: how to make practical decisions in light of ambiguous evidence. Promising no simple answers, this book does offer excellent food for thought for people pondering that next glass of wine.

Data Processing Handbook for Complex Biological Data provides relevant and to the point content for those who need to understand the different types of biological data and the techniques to process and interpret them. The book includes feedback the editor received from students studying at both undergraduate and graduate levels, and from her peers. In order to succeed in data processing for biological data sources, it is necessary to master the type of data and general methods and tools for modern data processing. For instance, many labs follow the path of interdisciplinary studies and get their data validated by several methods. Researchers at those labs may not perform all the techniques themselves, but either in collaboration or through outsourcing, they make use of a range of them, because, in the absence of cross validation using different techniques, the chances for acceptance of an article for publication in high profile journals is weakened.

2009 Choice Outstanding Academic Title 2009 Association of American University Presses Award for Jacket Design The stories of 70 women living in the aftermath of breast cancer Chemo brain. Fatigue. Chronic pain. Insomnia. Depression. These are just a few of the ongoing, debilitating symptoms that plague some breast-cancer survivors long after their treatments have officially ended. While there are hundreds of books about breast cancer, ranging from practical medical advice to inspirational stories of survivors, what has been missing until now is testimony from the thousands of women who continue to struggle with persistent health problems. After the Cure is a compelling read filled with fascinating portraits of more than seventy women who are living with the aftermath of breast cancer. Emily K. Abel is one of these women. She and her colleague, Saskia K. Subramanian, whose mother died of cancer, interviewed more than seventy breast cancer survivors who have suffered from post-treatment symptoms. Having heard repeatedly that "the problems are all in your head," many don't know where to turn for help. The doctors who now refuse to validate their symptoms are often the very ones they depended on to provide life-saving treatments. Sometimes family members who provided essential support through months of chemotherapy and radiation don't believe them. Their work lives, already disrupted by both cancer and its treatment, are further undermined by the lingering symptoms. And every symptom serves as a constant reminder of the trauma of diagnosis, the ordeal of treatment, and the specter of recurrence. Most narratives about surviving breast cancer end with the conclusion of chemotherapy and radiation, painting stereotypical portraits of triumphantly healthy survivors, women who not only survive but emerge better and stronger than before. Here, at last, survivors step out of the shadows and speak compellingly about their "real" stories, giving voice to the complicated, often painful realities of life after the cure. This book received funding from the Susan G. Komen Foundation.

Curcumin for Neurological and Psychiatric Disorders: Neurochemical and Pharmacological Properties focuses on the different molecular mechanisms underlying curcumin-mediated beneficial effects in neurological diseases. The book's editors discuss the neurochemical and pharmacological properties of curcumin, followed by the effect of curcumin in neurotraumatic diseases, neurodegenerative diseases, and neuropsychiatric diseases. The book also offers a perspective on future studies on the treatment of neurological disorders. The beneficial effects of curcumin have been observed both in cultured cells and in animal models, thus paving the way for ongoing present and future human clinical trials. Curcumin produces antioxidant and anti-inflammatory effects not only by blocking oxidative stress and neuroinflammation in neurotraumatic and neurodegenerative diseases, but also by restoring cellular homeostasis and rebalancing redox equilibrium.

The definitive "go to" text for Master's and Doctoral level courses on behavioral intervention research. It provides comprehensive coverage of the development, testing, and implementation of novel behavioral interventions in service and practice settings. This handbook provides comprehensive coverage of one of the most under-discussed and understood areas of public health research: developing, testing, and implementing novel behavioral interventions in service and practice settings. It examines the most critical issues related to behavioral intervention research in order to maximize the ability of intervention researchers to successfully implement current and future evidenced-based intervention protocols in targeted practice settings.

This book details the advances in drug discovery and delivery and the present need for emerging technologies. Throughout the text new micro and nanofabrication techniques are described, including methods like electrohydrodynamic processes, additive manufacturing, and microfluidics, which have the potential to produce drug delivery systems that were not possible a few years ago. This book is of great use to both entry-level and experienced researchers in the field of emerging technologies for the manufacturing of drug delivery devices.

This book provides a simplified, yet comprehensive, overview of the signalling pathways operating between and inside cells, which will help younger oncologists find their way in the labyrinth of signalling pathways and in the multitude of signals and signal receptors, transducers and effectors that contribute to oncogenesis. This comprehensive reference text is based on the master's courses delivered by Prof. Jacques Robert to graduate students at the University of Bordeaux, France. It includes a large number of colour schemas and figures that have been improved year after year for educational purposes. Signalling pathways are described individually and in depth, but without ignoring the multiplicity of interconnections and crosstalk. The presentation of each pathway is followed by a brief description of the alterations found in cancers as well as of the targeted pharmacological approaches that can be used to prevent or overcome the consequences of these oncogenic alterations. The basic mechanisms of molecular biology at the DNA replication, RNA transcription and protein activity levels are presented in a series of didactic annexes, enabling readers to better understand the alterations in signalling pathways.

"Hox Genes: Methods and Protocols" explores techniques and methodologies which arose from or were successfully applied to the study of Hox genes and Hox proteins, at the intersection of experimental embryology, genetics, biochemistry, physiology, evolutionary biology and other life sciences. This detailed volume begins with a section on discovery and functional analysis of Hox genes and then it continues onward to discuss mode of action and biomedical applications of Hox proteins. 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.

Expert and practical, "Hox Genes: Methods and Protocols" serves as an ideal guide to researchers striving to move forward in this dynamic and exciting area of study.

The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

Participatory Visual Methodologies in Global Public Health focuses on the use of participatory visual methodologies such as photovoice, participatory video (including cellphilming or the use of cell phones to make videos), drawing and mapping in public health research. These approaches are modes of inquiry that can engage participants and communities, eliciting evidence about their own health and well-being, as well as modes of representation and modes of production in the co-creation of knowledge, and modes of dissemination in relation to knowledge translation and mobilization. Thus, the production by a group of girls or young women of a set of photos or videos from their own visual perspective can offer new evidence on how, for example, they see sexual violence. Unlike other data such as those collected through surveys or even conventional interviews, the images they have produced not only inform the empirical evidence, but also do not need to remain in a laboratory or the office of a researcher. They can, through exhibitions and screenings, reach various audiences: school or health personnel, parents and community members, and perhaps also policy-makers. This collection offers a critical overview for students, practitioners, researchers and policy-makers working in or concerned with the use of participatory methodologies in public health around the globe. This book was originally published as a special issue of Global Public Health.

This book describes a novel and unique approach to the treatment of human diseases based on the study of natural animal models. A natural animal model is defined as an animal group or species that possesses a set of biochemical/physiological characteristics which are natural and adaptive for that animal, but are quite abnormal for humans. For example, how is it that birds can tolerate blood glucose concentrations which in humans are associated with diabetes. The natural animal model is living proof that a biological answer to this question is available. By studying natural animal models, we can gain valuable insights into the treatment of various human clinical disorders. Covering a wide range of disorders, this book describes in detail how medical scientists can take advantage of all the "research" that nature has already performed over billions of years in biological problem solving through extensive animal design testing and selection.

Introduction to Electrophysiological Methods and Instrumentation, Second Edition covers all topics of interest to electrophysiologists, neuroscientists and neurophysiologists, from the reliable penetration of cells and the behavior and function of the equipment, to the mathematical tools available for analyzing data. It discusses the pros and cons of techniques and methods used in electrophysiology and how to avoid pitfalls. Although the basics of electrophysiological techniques remain the principal purpose of this second edition, it now integrates several current developments, including, amongst others, automated recording for high throughput screening and multimodal recordings to correlate electrical activity with other physiological parameters collected by optical means. This book provides the electrophysiologist with the tools needed to understand his or her equipment and how to acquire and analyze low-voltage biological signals.