Since the discovery of actin by Straub in the 1950's and the pioneering work of Oosawa on actin self-assembly in helical laments in the 1960's, many books and conference proceedings have been published. As one of the most essential p- teins in life, essential for movement in organisms rangingfrom bacteria to higher eukaryotes, it is no surprise that actin has fascinated generations of scientists from many different elds. Actin can be considered as a "living treasure" of biology; the kinetics and thermodynamics of self-assembly, the dissipative nature of actin po- merization, the molecular interactions of monomeric and polymerized actin with regulators, the mechanical properties of actin gels, and more recently the force p- ducing motile and morphogenetic processes organized by the actin nanomachine in response to signaling, are all milestones in actin research. Discoveries that directly derive from and provide deeper insight into the fundamental properties of actin are constantly being made, making actin an ever appealing research molecule. At the same time, the explosion in new technologies and techniques in biological sciences has served to attract researchers from an expanding number of disciplines, to study actin. This book presents the latest developments of these new multiscale approaches of force and movement powered by self-assembly processes, with the hope to opening our perspectives on the many areas of actin-based motility research.

This contributed volume explores the ways in which researchers engineer new biomaterials for the challenging problems of the peripheral and central nervous systems. These biomaterials are uniquely positioned for use in creating in vitro models of injury and disease, testing therapeutic treatments, understanding neural development, and mapping the multi-scalar environment of the brain. This book informs readers from biology, chemistry, materials science, engineering, and neuroscience on cutting edge research in engineering technologies, from fundamental material development through pre-clinical studies. The book also highlights target applications in three areas of research: (1) engineering neural models and materials, (2) probing biological underpinnings of neurological function and disease, and (3) designing therapeutic and diagnostic treatments for neurological disease.

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

While regression models have become standard tools in medical research, understanding how to properly apply the models and interpret the results is often challenging for beginners. Regression Models as a Tool in Medical Research presents the fundamental concepts and important aspects of regression models most commonly used in medical research, including the classical regression model for continuous outcomes, the logistic regression model for binary outcomes, and the Cox proportional hazards model for survival data. The text emphasizes adequate use, correct interpretation of results, appropriate presentation of results, and avoidance of potential pitfalls. After reviewing popular models and basic methods, the book focuses on advanced topics and techniques. It considers the comparison of regression coefficients, the selection of covariates, the modeling of nonlinear and nonadditive effects, and the analysis of clustered and longitudinal data, highlighting the impact of selection mechanisms, measurement error, and incomplete covariate data. The text then covers the use of regression models to construct risk scores and predictors. It also gives an overview of more specific regression models and their applications as well as alternatives to regression modeling. The mathematical details underlying the estimation and inference techniques are provided in the appendices.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Volume 63 of "Progress in Drug Research" is devoted to recent developments in targeted cancer therapy. Significant advances in the fields of molecular and tumor biology over the past decade have led to this exciting new era in c- cer therapeutics with an intensive effort in rationally-designed cancer the- peutic strategies directed against selective molecular targets. These selective approaches may ultimately lead to tailoring treatments to individual patients where molecular biomarkers of sensitivity to therapy are identified, prod- ing better tolerated therapies with less side effects than past experiences with cytotoxic cancer chemotherapy, and reducing cancer to a controlled, chronic state. This volume contains eleven chapters, including updated reviews on a range of targets, such as tumor angiogenesis, apoptosis/cell survival pa- ways, and various inhibitors of cyclin-dependent kinases, cyclooxygenase-2 (COX-2), epidermal growth factor receptor (EGFR), and histone deacetylases (HDAC). Additional topics, including target validation, polypharmacology and potential synergy of involving multiple targets, antisense approaches, animal models for preclinical development of targeted agents, and obstacles, including development of resistance are also presented. In addition, the p- ticular challenges involved in translating preclinical data to clinical appli- tion are discussed. It gives me great pleasure to present this new volume. I would like to express my gratitude to the chapter authors, to Birkhauser Verlag and, in particular, to Dr. Beatrice Menz and Ms. Gabriele Poppen for their assistance in compiling and editing this volume. April 2005 Richard M. Schultz vii Progress in Drug Research, Vol. 63 (R. M. Schultz, Ed.

This narrative of a cancer researcher spans a period in which biomedicine research has been so revolutionary. The educational background and socioeconomic circumstances of the author make the story unique, shedding light on many important intellectual achievements. The author also provides an insightful view on how decisions at the upper echelon of scientific institutions affect cancer researchers. The vivid account of scientific discovery and intellectual evolution provides a fine example for the next generation of cancer researchers.

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.

Lectins have in the past been regarded by many scientists as curious proteins of uncertain structure and specificity that bind to carbohydrates of dubious significance themselves. All this is rapidly changing. The functional importance of glycosylation in cell-cell and cell-pathogen interactions, as well as intracellular events, has been recognized by the explosion of the science of glycobiology. This has been paralleled by the realization that lectins, once they have been well characterized, can be extremely useful tools for exam- ing structural changes in glycosylation and their functional consequences for human pathophysiology. Different lectins vary considerably in their degree of specificity. Some, such as wheatgerm agglutinin, have fairly broad specificity (for glucosamine or sialic acid), whereas others, such as Maackia amurensis, are specific not only for a single carbohydrate, but also for its linkage (2-3 linked sialic acid). Lectins with relatively broad specificity may be very useful as an adjunct to isolation or quantification of soluble glycoproteins, whereas lectins of known, and precise, specificity will be more useful for characterization of carbo- drate structure. We have included an appendix in Lectin Methods and Pro- cols that provides the known specificities of all lectins cited in the text.

This volume takes an in-depth look at the potential pharmacological applications of 11 important antidiabetic plants, examining their antihyperglycemic, hypoglycemic, and anti-lipidemic properties along with current genome editing research perspectives. Plant natural products, or phytoconstituents, are promising candidates for antidiabetic pharmacological actions. The phytoconstituents, such as i' avonoids, terpenoids, saponins, carotenoids, alkaloids and glycosides, play vital roles in the current and future potent antidiabetic drug development programs Each chapter reviews a particular plant with antidiabetic properties, explaining the therapeutic aspects, its active antidiabetic compounds, and relevant genome editing technology. The specific plants discussed include Azadirachta indica (commonly known as neem, nimtree or Indian lilac), Gymnema sylvestre (commonly called gymnema, Australian cowplant, and Periploca of the woods), Syzygium cumini (commonly known as Malabar plum, Java plum, black plum, jamun or jambolana), Ceylon cinnamon (or true cinnamon, as opposed to cassia cinnamon), insulin plant (or Costus pictus), Trigonella foenum-graecum (better known as fenugreek), Mulberry, Nigella sativa L. (black caraway, also known as black cumin, nigella, kalojeera, kalonji or kalanji), Aegle marmelos (L.) (commonly known as bael (or bili or bhel), also Bengal quince, golden apple, Japanese bitter orange, stone apple or wood apple), Ficus benghalensis (the banyan, banyan fig and Indian banyan), and of course, garlic (Allium sativum). Antidiabetic Plants for Drug Discovery: Pharmacology, Secondary Metabolite Profiling, and Ingredients with Insulin Mimetic Activity will serve as a valuable source of information for students, drug researchers, medical practitioners, diabetic patients, and many others in the effort to gain understand of how these plant drug molecules can help fight diabetes.

This book presents a road map for applying the stages in conceptualization, evaluation, and testing of biomedical devices in a systematic order of approach, leading to solutions for medical problems within a well-deserved safety limit. The issues discussed will pave the way for understanding the preliminary concepts used in modern biomedical device engineering, which include medical imaging, computational fluid dynamics, finite element analysis, particle image velocimetry, and rapid prototyping. This book would undoubtedly be of use to biomedical engineers, medical doctors, radiologists, and any other professionals related to the research and development of devices for health care.

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.

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.

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.

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 open access book is the outcome of a Global Forum on Innovation, Intellectual Property and Access to Medicines held in December 2019 at the Max Plank Instititute in Munich, organised by the South Centre and the Max Plank Institute. The academics and experts from international organisations participating have contributed chapters to this book. The book is for policy makers (in Ministries of Health, Ministries of Trade, Ministries of Foreign Affairs, patent offices), but also relevant for academics (law, trade, public health), on the flexibilities available in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization to promote access to medicines.

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."

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

One of the most challenging aspects of the current healthcare system, especially for nurses, is cultural diversity across a variety of societies.Nurses, caregivers, and other practitioners must be equipped and aware of their patients' cultural background in order to respond appropriately and sensitively while providing the proper care. Clearly the techniques and beliefs within cultures is highly diverse, requiring those providing care to possess knowledge that allows them to combine global and cultural practices into their day-to-day occupation. This consist of not only learning cultural differences and similarities, but examining nursing throughout other parts of the world, and the health problems being faced in different geographical settings. This volume is intended to provide nurses, physicians, specialists, and providers with the information needed to provide capable care and treatment to individuals of diverse cultures. Each chapter author was selected for their interest and knowledge of transcultural and social research. The content of this volume provides a look at classic contributions to the field, up-to-date research, and evaluates the impact of diverse cultures on issues that may affect nursing and health care, such as: Key Topics: Leininger's Culture Care Diversity and Universality The Current State of Transcultural Nursing Transcultural Mental Health Nursing Culture and Consent in Clinical Care Obesity Among African Immigrant Populations Cultural Factors Influencing Suicidal Thoughts and Behaviors

What is research and how does it work in the context of nursing, health and social care? This introductory guide provides you with a concise overview of the different research methods and terminology that you will come across when undertaking research in any course related to nursing, health and social care. The book's easy-to-follow structure takes you from research novice to confident researcher, helping you to make sense of research and understand how it is implemented in healthcare practice. The new edition includes: Updates in light of the 2018 NMC standards, with more information on the impact of GDPR, consent and vulnerable groups, Personal and Public Involvement (PPI), and work-based projects. Improved case examples of real research, with more on group work, poster presentations, research output and dissemination, literature reviews, and dissertations. Upgraded activities that include reflective exercises, critical appraisal tools, a dissemination plan, and a glossary, all in the book. This is essential reading for undergraduate and postgraduate students within the health and therapy professions, nurses, midwives, physiotherapists, radiographers, occupational therapists, speech and language therapists, and paramedics.

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.

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