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.

Motivating learners to explore and investigate scientific concepts, this new core Course Book helps learners actively connect study with wider issues relevant to the world today. The most comprehensive match to the new syllabus first examined 2017 and the only DP Environmental Systems developed directly with the IB, the inquiry-based approach truly engages learners, strengthening achievement. Integrated links to the Big Questions support a holistic approach to teaching and learning, encouraging students to make links between topics and other subjects. Truly engage learners with scientific concepts - the inquiry-based approach drives active exploration, investigation and critical thought. Fully cover the new syllabus - the most comprehensive support for the new syllabus (first examination 2017), developed directly with the IB. Strengthen achievement - current case studies and activities accessibly connect learning with relevant global issues, driving motivation and achievement. Accurately implement the new requirements- written by DP Curriculum Developers and authors of the new syllabus. Support the new internal assessment - fresh ideas and new approaches to practicals from Gillian Williams help you tackle the changes. Build assessment potential - assessment support directly from the IB provides unrivalled exam preparation. The online Course Book will be available on Oxford Education Bookshelf until 2023. Access is facilitated via a unique code, which is sent in the mail. The code must be linked to an email address, creating a user account. Access may be transferred once to a new user, once the initial user no longer requires access. You will need to contact your local Educational Consultant to arrange this.

Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

This book presents a collection of chapters on modern bioelectrochemistry focusing on new materials for biodevice, bioelectrosynthesis and bioenergy. The chapters cover protein engineering, semiconductors, biorecognition, graphene-based bioelectronics, bioelectrosynthesis, biofuel cells, bioinspired batteries and biophotovoltaics.

Oxidative damage appears to play a central role in the development of a wide range of tissue pathology, including neurodegenerative disease, drug side-effects, xenobiotic toxicity, carcinogenesis, and the aging process, to name just a few. Because of the centrality of oxidative processes to normal and abnormal tissue function, it has become imperative to develop appropriate analytical techniques to facilitate the quantitation of significant reactants. Without advances in methodology, corresponding advances in our knowledge of underlying biochemical events will be necessarily limited. Drs. Hensley and Floyd have done an outstanding job of assembling the work of world-class experts into Methods in Biological Oxidative Stress. The contributors have presented concise, yet thorough, descriptions of the state-of-the-art methods that any investigator working in the field needs to access. Mannfred A. Hollinger v Preface Free radicals and reactive oxidizing agents were once ignored as biochemical entities not worth close scrutiny, but are now recognized as causes or contributing factors in dozens, if not hundreds, of disease states. In addition, free radical metabolisms of xenobiotics have become increasingly important to pharmacologists. Accordingly, the need has arisen to accurately quantify reactive oxygen species and their byproducts. Methods in Biological Oxidative Stress is practical in scope, providing the details of up-to-date techniques for measuring oxidative stress and detecting oxidizing agents both in vitro and in vivo. The contributors are recognized experts in the field of oxidative stress who have developed novel strategies for studying biological oxidations.

The International Society for Systems Biology (ISSB) is a society aimed at advancing world-wide systems biology research by providing a forum for scientific discussions and various academic services. The ISSB helps coordinate researchers to form alliances for meeting the unique needs of multidisciplinary and international systems biology research. The annual International Conference on Systems Biology (ICSB) serves as the main meeting for the society and is one of the largest academic and commercial gatherings under the broad heading of Systems Biology .

This volume discusses the vaccine development process and the role delivery concepts contribute to a global goal of effective health outcomes. The chapters in this book cover a wide range of topics such as antigen discovery methods; genetic and protein antigen preparation; preparation of viral vaccines as VLPs; viral and non-viral gene delivery; needle-less or non-invasive delivery technology; vaccine storage; and vaccine administration and assessment. 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. Cutting-edge and practical, Vaccine Delivery Technology: Methods and Protocols is a valuable resource for both novice and expert researchers, in and outside the field, who would like to gain insight into the impactful field of vaccines. Chapter 7 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

AbouttheNorthwestSymposiumforSystemsBiology This publication is the proceedingsofthe Pacific Northwest National Laboratory (PNNL) inaugural meeting of the Northwest Symposium for Systems Biology, held October 17 and 18,2002, in Richland, Washington. This is the40thyear in which the laboratory has held an interdisciplinary science symposium to address important biologicalquestions. Inyearspast, theunifyingthemewasenvironmentalsciences.This yearwebegananewseriesofsymposiaonsystemsbiology.Aparticularfocusofthese symposiawill beon identifyingcurrentbreakthroughtechnologiesand theirapplication toimportantmodelsystems. PNNLestablished theBiomolecularSystemsInitiative(BSI) toexploit the unique andinnovativetechnologiesdevelopedhereatthelaboratory, especiallyattheWilliamR. Wiley Environmental Molecular Sciences Laboratory (EMSL). The BSI is a multidisciplinary research program thatfocuses on theareasofresearch that will drive biology in the post-genomic era. It combines cutting-edge capabilities for high throughputproteomics, cellimaging, quantitativebiology, andcomputationalbiology. To understand complex biological systems, scientists must acquire detailed knowledgeaboutcellsignaling, andabouthownetworksregulatecellfunctions.Thiswill requireanintegratedeffortacrossavarietyofresearchdisciplines: molecularandcellular biology, biochemistry, physics, mathematics, and information science. The BSI is working to provide opportunities for scientists from different disciplines to gatherand discusscell networksatallscalesaswell asapproachesforunderstandingthemolecular componentsofthesenetworks. The theme of this year's symposium was the U.S. Department ofEnergy's new Genomes to Life (GTL) program. GTL has the eventual goal of a fundamental, comprehensive, andsystematicunderstandingoflife. In its initial implementation, GTL focusesonpost-genomicapproachestounderstanding ComplexMicrobialSystems ComputationalMethods MolecularMachines: Multiproteincomplexes GeneRegulatoryNetworks."

This book is addressed to students, researchers and academics who have barely heard of the emerging young science of Biosemiotics, and who want to know more about it. Written by many of the fielda (TM)s major contributors, it provides a highly qualified introduction to Biosemiotics and illustrates the most recent views in its background and development.

Combining research approaches from biology, philosophy and linguistics, the field of Biosemiotics proposes that animals, plants and single cells all engage in semiosis a" the conversion of objective signals into conventional signs. This has important implications and applications for issues ranging from natural selection to animal behavior and human psychology, leaving biosemiotics at the cutting edge of the research on the fundamentals of life.

Drawing on an international expertise, the book details the history and study of biosemiotics, and provides a state-of-the-art summary of the current work in this new field. And, with relevance to a wide range of disciplines a" from linguistics and semiotics to evolutionary phenomena and the philosophy of biology a" the book provides an important text for both students and established researchers, while marking a vital step in the evolution of a new biological paradigm.

Marcello Barbieri is University Professor of Embryology at the University of Ferrara, Italy, President of the Italian Association for Theoretical Biology and Editor-in-Chief of the Journal of Biosemiotics.

This Revision Workbook provides a comprehensive collection of examination-style questions covering each topic from the WJEC Biology for A2 Level specification. // Ideal for examination preparation, exam question practice and for improving examination technique. // Enables students to build on their knowledge of key areas of study and develop their confidence in the subject. // Helps students understand what is required in an exam and develop the skills needed to be effective in an exam situation. // Includes advice on how students can refine their exam technique and improve their grade potential. // The helpful write-in format, together with the answers, enables students to check their progress as they work through the course.

This dictionary is intended as a guide to the terminology used in a wide range of animal-related programmes of study including agriculture, animal care, animal management, animal production, animal welfare, veterinary nursing, wildlife conservation and zoo biology. In total it contains over 5,300 entries. It contains a wide range of terms used in the fields of veterinary science, physiology and zoology, as students whose primary interests are animal welfare or zoo biology also need to have some understanding of disease, how animal bodies function and how animals are classified. It also contains some legal terms, and reference to some legal cases, to help students understand how the protection, use and conservation of animals is regulated by the law. Some people, famous animals, literature and films have influenced the way we think about, and behave towards, animals. For this reason, the book includes references to important books about animals, famous animals who have starred in films or been the subject of scientific studies, along with short biographies of famous scientists and others who have studied animals or established conservation or animal welfare organisations.

This book is intended as an overview at an undergraduate or early university level and describes the effects of spaceflight at cellular and organism levels. Past, current, and future research on the effects of gravity - or its absence - and ionizing radiation on the evolution, development, and function of living organisms is presented in layman's terms by researchers who have been active in this field. The purpose is to enlighten science and non-science readers to the benefits of space biology research for conducting basic and applied research to support human exploration of space and to take advantage of the space environment as a laboratory for scientific, technological, and commercial research. The first chapters present an overview of the major focuses of space research in biology, as well as the history and the list of animals and plants that have flown in space to date.

This one-semester text is designed for an upper-level majors course. Vertebrates features a unique emphasis on function and evolution of vertebrates, complete anatomical detail, and excellent pedagogy. Vertebrate groups are organized phylogenetically, and their systems discussed within such a context. Morphology is foremost, but the author has developed and integrated an understanding of function and evolution into the discussion of anatomy of the various systems.

This book presents a multidisciplinary assessment of the state of science in the use of systemic delivery technologies to deliver anti-aging therapeutics now under development. There is a gap between basic aging research and the development of intervention technologies. This major obstacle must be overcome before biogerontological interventions can be put into clinical practice. As biogerontology comes to understand aging as a systemic degenerative process, it is clear that there is a pressing need for technologies that enable cells and tissues in a fully developed adult body to be manipulated systemically to combat aging. The authors review advances in the chemistry and engineering of systemic delivery methods and analyze the strengths and limitations of each. The book is organized into six sections. The first offers an overview of the need for systemic delivery technologies alongside the development of anti-aging therapies and describes approaches that will be required for studying the properties and efficiency of carriers for systemic delivery. Sections II, III and IV describe recent advances in a range of strategies that may enable systemic delivery to help combat aging conditions ranging from cell senescence to decline in immune function and hormonal secretion. Section V discusses practical strategies to engineer and optimize the performance of delivery technologies for applications in systemic delivery, along with their working principles. The final section discusses technical and biological barriers that must be overcome as systemic delivery technologies move from research laboratory to clinical applications aimed at tackling aging and age-associated diseases.Benefiting scholars, students and a broader audience of interested readers, the book includes helpful glossary sections in each chapter, as well as sidebars that highlight important notes, and questions for future research.

Toby K. Eisenstein Symposium Committee Chairperson Temple University School of Medicine Philadelphia, Pennsylvania 19140 This symposium is the thirteenth biennial clinical microbiology program sponsored by the Eastern Pennsylvania Branch of the American Society for Microbiology in cooperation with the Philadelphia area medical schools and the Bureau of Laboratories of the Pennsylvania Department of Health. This year a generous contribution from Merck, Sharp and Dohme has helped to make the program a reality. The subject matter for this symposium represents an attractive spectrum of medical, biological and molecular approaches to the practical solution of a public health prob1em--name1y, prevention of infection with the hepatitis B virus. The symposium may be unique in that it focuses on a product which was first marketed less than three months ago, but included in the program are presen tations on two new approaches to hepatitis B vaccine production which may replace the one which is newly unveiled. The rapidity of progress in our present era of biological research is indeed astonishing."

A knowledge of how plants have responded to environmental change in the past is our principal source of evidence for predicting how they might respond to the new environments of the future and a knowledge of past climates may enable us to assess more clearly the human contribution to the climatic changes of the future. This book aims to present the results of investigations into the history of the world's plant cover over the last 65 million years, not the methods by which these results have been achieved, and to document a selection of published accounts, both general and specific, for further reading. The book is organized into four main sections, dealing successively with the tenet that modern plant distributions and communities have been moulded by long-term environmental change, the nature of global environmental change over the last 65 million years, the ways in which plants and plant communities have responded to environmental change, and the global history of forest, dryland and coldland communities over the last 65 million years. The final chapter considers the future.

Global Climate Change and Plant Stress Management Understand the impact of climate change on plant growth with this timely introduction Climate change has had unprecedented consequences for plant metabolism and plant growth. In botany, adverse effects of this kind are called plant stress conditions; in recent years, the plant stress conditions generated by climate change have been the subject of considerable study. Plants have exhibited increased photosynthesis, increased water requirements, and more. There is an urgent need to understand and address these changes as we adapt to drastic changes in the global climate. Global Climate Change and Plant Stress Management presents a comprehensive guide to the effects of global climate change on plants and plant metabolism. It introduces and describes each climate change-related condition and its components, offering a detailed analysis of the resulting stress conditions, the environmental factors which ameliorate or exacerbate them, and possible solutions. The result is a thorough, rigorous introduction to this critical subject for the future of our biome. Readers will also find: Analysis of global climate change impact on various agricultural practices Socio-economic consequences of climate change and plant stress conditions, and possible solutions Strategies for sustainable agriculture Global Climate Change and Plant Stress Management is essential for researchers, scientists, and industry professionals working in the life sciences, as well as for advanced graduate students.

During the last two decades, structural equation modeling (SEM) has emerged as a powerful multivariate data analysis tool in social science research settings, especially in the fields of sociology, psychology, and education. Although its roots can be traced back to the first half of this century, when Spearman (1904) developed factor analysis and Wright (1934) introduced path analysis, it was not until the 1970s that the works by Karl Joreskog and his associates (e. g., Joreskog, 1977; Joreskog and Van Thillo, 1973) began to make general SEM techniques accessible to the social and behavioral science research communities. Today, with the development and increasing avail ability of SEM computer programs, SEM has become a well-established and respected data analysis method, incorporating many of the traditional analysis techniques as special cases. State-of-the-art SEM software packages such as LISREL (Joreskog and Sorbom, 1993a, b) and EQS (Bentler, 1993; Bentler and Wu, 1993) handle a variety of ordinary least squares regression designs as well as complex structural equation models involving variables with arbitrary distributions. Unfortunately, many students and researchers hesitate to use SEM methods, perhaps due to the somewhat complex underlying statistical repre sentation and theory. In my opinion, social science students and researchers can benefit greatly from acquiring knowledge and skills in SEM since the methods-applied appropriately-can provide a bridge between the theo retical and empirical aspects of behavioral research."

Quantities, Symbols, Units, and Abbreviations in the Life Sciences is a reliable compilation of the most up-to-date recommendations for using units, symbols, abbreviations, and acronyms in scientific publications across the biological sciences. Drawing on the authority of the various nomenclature committees of the many international societies in the biosciences, as well as on the editors of prestigious scientific journals, and on eminent individuals active in scientific publishing, this essential reference provides authors and editors with easy access to the authoritative usage of the universally accepted terms they need for clear scientific communication. The compiled symbols, units, and abbreviations are defined, with commentary and some etymological background frequently provided. The diverse scope of disciplines treated includes biochemistry, molecular biology, medicine, genetics, immunology, and virology, plus appropriate sections on mathematics, physics, and chemistry.

The modern developments in mathematical biology took place roughly between 1920 and 1940, a period now referred to as the "Golden Age of Theoretical Biology." The eminent Italian mathematician Vito Volterra played a decisive and widely acknowledged role in these developments. Volterra's specific project was to transfer the model and the concepts of classical mechanics to biology, constructing a sort of "rational mechanics" and an "analytic mechanics" of biological associations. The new subject was thus to be equipped with a solid experimental or at least empirical basis, also in this case following the tried and tested example of mathematical physics. Although very few specific features of this reductionist programme have actually survived, Volterra's contribution was decisive, as is now universally acknowledged, in encouraging fresh studies in the field of mathematical biology. Even today, the primary reference in the literature of the field of population dynamics consists of Volterra's work and the descriptive schemata (the "models," in modern parlance) he proposed. The present book aims to fill this historiographic gap by providing an exhaustive collection of the correspondence between Volterra and numerous other scientists on the topic of mathematical biology. The book begins with an introductory essay by Ana MillAn Gasca, which aims at giving a picture of the research field of biomathematics in the "Golden Age," and shows the importance of the correspondence in this context. This is followed by a transcript of the correspondence ordered by the correspondent's name. Each item is preceded by a biographical profile of the correspondent and accompanied by notes containing informationand references to facilitate understanding. The book will be found useful not only by science historians but also by all those - in particular, biomathematicians and biologists - with an interest in the origins of and events in a branch of learning that has undergone an astonishing development. Many of the problems discussed - in particular that of empirical verification - appear extremely topical even today and in some cases could even fuel reflection on topics still open to research.

Specialist Periodical Reports provide systematic and detailed review coverage of progress in the major areas of chemical research. Written by experts in their specialist fields the series creates a unique service for the active research chemist, supplying regular critical in-depth accounts of progress in particular areas of chemistry. For over 80 years the Royal Society of Chemistry and its predecessor, the Chemical Society, have been publishing reports charting developments in chemistry, which originally took the form of Annual Reports. However, by 1967 the whole spectrum of chemistry could no longer be contained within one volume and the series Specialist Periodical Reports was born. The Annual Reports themselves still existed but were divided into two, and subsequently three, volumes covering Inorganic, Organic and Physical Chemistry. For more general coverage of the highlights in chemistry they remain a 'must'. Since that time the SPR series has altered according to the fluctuating degree of activity in various fields of chemistry. Some titles have remained unchanged, while others have altered their emphasis along with their titles; some have been combined under a new name whereas others have had to be discontinued. The current list of Specialist Periodical Reports can be seen on the inside flap of this volume.