This is a book about how global unionism was born in the maritime shipping sector. It argues that the industrial structure of shipping, and specifically the interconnected nature of shipping production chains, facilitated the globalization of union bargaining strategy, and the transnationalization of union structures for mobilizing industrial action. This, in turn, led to global collective bargaining institutions and effective union participation in global regulatory politics. This study uses a variety of source and analytical techniques, relying heavily on interviews with union official and other maritime industry people in many countries.

Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II-III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.

With a DVD of color figures, Clustering in Bioinformatics and Drug Discovery provides an expert guide on extracting the most pertinent information from pharmaceutical and biomedical data. It offers a concise overview of common and recent clustering methods used in bioinformatics and drug discovery. Setting the stage for subsequent material, the first three chapters of the book introduce statistical learning theory, exploratory data analysis, clustering algorithms, different types of data, graph theory, and various clustering forms. In the following chapters on partitional, cluster sampling, and hierarchical algorithms, the book provides readers with enough detail to obtain a basic understanding of cluster analysis for bioinformatics and drug discovery. The remaining chapters cover more advanced methods, such as hybrid and parallel algorithms, as well as details related to specific types of data, including asymmetry, ambiguity, validation measures, and visualization. This book explores the application of cluster analysis in the areas of bioinformatics and cheminformatics as they relate to drug discovery. Clarifying the use and misuse of clustering methods, it helps readers understand the relative merits of these methods and evaluate results so that useful hypotheses can be developed and tested.

The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. Frailty Models in Survival Analysis presents a comprehensive overview of the fundamental approaches in the area of frailty models. The book extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copula models; discusses problems related to frailty models, such as tests for homogeneity; and describes parametric and semiparametric models using both frequentist and Bayesian approaches. He also shows how to apply the models to real data using the statistical packages of R, SAS, and Stata. The appendix provides the technical mathematical results used throughout. Written in nontechnical terms accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real-world data application and interpretation of the results. By applying several models to the same data, it allows for the comparison of their advantages and limitations under varying model assumptions. The book also employs simulations to analyze the finite sample size performance of the models.

Design Principles and Analysis Techniques for HRQoL Clinical Trials
SAS, R, and SPSS examples realistically show how to implement methods

Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical methods, such as mixed effect models, to their own studies. The author illustrates the implementation of the methods using the statistical software packages SAS, SPSS, and R.

New to the Second Edition

• Data sets available for download online, allowing readers to replicate the analyses presented in the text
• New chapter on testing models that involve moderation and mediation
• Revised discussions of multiple comparisons procedures that focus on the integration of health-related quality of life (HRQoL) outcomes with other study outcomes using gatekeeper strategies
• Recent methodological developments for the analysis of trials with missing data
• New chapter on quality adjusted life-years (QALYs) and QTWiST specific to clinical trials
• Additional examples of the implementation of basic models and other selected applications in R and SPSS

This edition continues to provide practical information for researchers directly involved in the design and analysis of HRQoL studies as well as for those who evaluate the design and interpret the results of HRQoL research. By following the examples in the book, readers will be able to apply the steps to their own trials.

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
• ICH Guidance Q8, Q9, and Q10 expectations
• FDA cGMPs for the 21st Century Initiative and associated guidance
• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• the indirect developments from FDA/EU/Japan regulators and industry
• the role of QA department, and internal and external suppliers
• the integration of computer systems validation into single overall approach for wider system
• practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
• managing outsource partners and handling legacy systems
• topical issues uncovered by regulatory authorities including US FDA

This compilation presents original study results on the leading edge of neuroscience research. Each article has been carefully selected in an attempt to present substantial research results across a broad spectrum. Included in this volume is research on holographic memory; epilepsy and psychiatric co-morbidities; emotional modulation of prepulse inhibition of the startle response in humans; neuroimaging and electrophysiology efficacy in measuring acute effects and long-term sequelae following sports-related concussion; children with writing disabilities; neuroimmune connections in the posterior nasopharyngeal cavity; pulse attraction-repulsion; autism spectrum disorders in children and adolescents with neurofibromatosis type 1; avidity of autoantibodies against antigens in nervous tissue; epidemiological study of childhood epilepsy using the newly classification proposed by the international league against epilepsy; and the role of neuromuscular ultrasound in the diagnostic of the multifocal motor neuropathy.

The authors' of this book discuss the most recent advances in neuroscience research. The chapters include updated information on clinical and technical implementation of digital subtraction angiography (DSA) in stroke imaging; association between word display and executive functioning; the connectivity between the cerebellum and inferior frontal gyrus (IFG); the identification and validation of EEG, MRI and SPECT biomarkers for diagnosing, monitoring progression and predicting the onset of Alzheimer's disease (AD); an examination of the leptin receptor, a drive of adult neurogenesis that may treat Alzheimer's disease; the language of neurons and their clinical applications such as in deep brain stimulation; the use of folic acid and its intake by pregnant women to support both physiological changes in the mother and the optimal growth and development of the fetus and offspring; examples of the continuum of shapes and sizes of different dendritic spines, from simple to complex, observed in the human brain; an examination of spastic diplegia, the most common form of cerebral palsy; and the identification of new mechanisms of pharmacological effects of certain neurotropic peptides.

Tryptophan is not only an essential amino acid but also an effective signaling molecule as an indicator of amino acid sufficiency. Serotonin is biosynthesized from the essential amino acid tryptophan. The first chapter of this book deals with the effects of tryptophan as well as some strategies of treatments that modify serotonin levels on cognitive processes during aging and neurodegenerative diseases. The changes of tryptophan metabolism under immunological challenges and physiological conditions like stress are examined as well. In the third chapter, the authors illustrate the key role of L-tryptophan in metabolic functions with special emphasis on the alterations of circadian rhythms. The remaining chapters of the book focus on new research findings on L-tryptophan synthesis from D-serine; the complex experimental and theoretical studies of the tryptophan molecule in its collisions with low and high energy electrons; and finally, a commentary on a novel tryptophan-selective amino acid transporter that is functionally coupled to ID01-dependent signaling pathways.

The go-to guide to evidence-based practice in nursing for more than a decade, Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice, 5th Edition, presents the latest perspectives on research-backed nursing practice in an engaging, user-friendly approach that has made this the bestselling resource of its kind.    AJN award-winning authors Bernadette Melnyk and Ellen Fineout-Overholt combine straightforward, conversational storytelling, inspiring quotes, and engaging case studies to make evidence-based practice accessible for students at any level of familiarity. With real-world examples and meaningful strategies in every chapter, this revised and reimagined 5th Edition gives students the confidence to meet today’s clinical challenges and ensure the most effective patient outcomes for years to come.      New to this edition: NEW! Reimagined coverage and a new chapter on applying implementation science to clinical practice settings familiarize students with the latest evidence and emerging implementation and evaluation tools.  UPDATED! Content throughout empowers you to more effectively teach evidence-based practice principles in academic and clinical settings. UPDATED! Making EPB Real case studies reinforce clinical application through real-world examples. 

It is clear that many fascinating problems still remain to be addressed in parasite transmission modelling, from better understanding of transmission processes and natural history of infection to investigating the impact of ecological and spatial scales, climate change, host immunity and social behaviour, parasite-host evolutionary dynamics and parasite community ecology on parasite transmission. This book captures some of the advances made in recent years and provides indications of ways forward for addressing these questions by shedding light on developments in conceptual frameworks and modelling tools as well as the emergence of new data forms for aiding model construction, testing and analysis. Another important advance has been the parallel development of robust computationally-intensive statistical methods to allow model testing and parameterization by aiding the fitting of models to complex data. This is an exciting area of work, which we believe will broaden the scope of mathematical modelling in investigating parasite transmission processes. In particular, we expect this advance will now allow modellers to begin the successful development and analysis of mechanistically-rich models of parasite transmission that will facilitate better integration of the variety of mechanisms increasingly recognized as important in simultaneously affecting transmission, including abiotic processes, trophic and evolutionary interactions, movement in space, and behaviour and even physiology of the individual. We foresee a continuing bright future for using mathematical modelling to clarify parasite transmission dynamics and address problems related to effective parasite control. Ultimately, through this improved application of models to research and management, we expect that parasite control would be an achievable goal bringing benefits to a vast number of our fellow human beings.

Researching, Reflecting and Writing about Work provides a guide to the research skills and critical thinking required to complete a research project for professional learning courses in counselling and psychotherapy.

Written at a level easily accessible to those enrolled on a work-based qualification as well as those considering postgraduate research at master's level, this book includes:

• how we reflect on our work
• discussion on preparation and structuring of a case study
• how to present work in supervision with advice on process recording
• essay plan structures and appropriate methodologies for research
• ethical considerations and critical linking
• dilemmas and tensions involved in research at work .

Key learning points and reflective exercises are included throughout and theory is supported by contributions detailing specific learning experiences from a variety of work settings, including the public sector, an organisation, in the community, and as an independent counsellor in a voluntary agency. There is also a section on how to prepare your research for consideration for publication and how to present your findings to colleagues.

Researching, Reflecting and Writing about Work will be of interest to all those on counselling courses, or training as psychotherapists, as well as people involved in professional learning linked to the helping professions, including those interested in work-based research linked to therapy in any setting.

Originally published in 1997 Evolutionary Change addresses the somatic mechanism of change. Although astounding advances in molecular biology have opened up new engineering possibilities to shape our future in terms of "improving" the human species as well as eradicating all kinds of pathological characteristics of biological development, these possibilities pose potentially serious dangers. They arise primarily from the local nature of changes that are introduced and the impact of the environment on the overall development of the biological system. The book explores the biological mechanisms of change in their entirety - as they fit into the general dynamics of biological systems - and demonstrates the pitfalls of tackling change from a narrow perspective, using cancer as an example of certain pathological manifestations of these mechanisms of change.

Researching, Reflecting and Writing about Work provides a guide to the research skills and critical thinking required to complete a research project for professional learning courses in counselling and psychotherapy.

Written at a level easily accessible to those enrolled on a work-based qualification as well as those considering postgraduate research at master's level, this book includes:

• how we reflect on our work
• discussion on preparation and structuring of a case study
• how to present work in supervision with advice on process recording
• essay plan structures and appropriate methodologies for research
• ethical considerations and critical linking
• dilemmas and tensions involved in 'research at work'.

Key learning points and reflective exercises are included throughout and theory is supported by contributions detailing specific learning experiences from a variety of work settings, including the public sector, an organisation, in the community, and as an independent counsellor in a voluntary agency. There is also a section on how to prepare your research for consideration for publication and how to present your findings to colleagues.

Researching, Reflecting and Writing about Work will be of interest to all those on counselling courses, or training as psychotherapists, as well as people involved in professional learning linked to the helping professions, including those interested in work-based research linked to therapy in any setting.

"The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: ""

First published in 1998, this volume examines a major function of research which is to strengthen the knowledge base of health professions and so enhance patient care. The rapid growth has unfortunately led to it being seen by many as an elitist activity full of jargon, carried out by academics. This to some degree has led to a theory practice gap with some professionals not recognising their important role within the research process. It is important to dispel the myth that all practitioner should carry out research, though they should use elements of the research process to develop a questioning and evaluative approach to care. This book will enable reader to demystify and enhance their understanding of terminology used in research and contains almost 300 terms. It offers readers a unique approach to explanations for each term by offering its Everyday use; its Research use; an Example and Related terms.

This book covers the basic experimental models in glioblastoma research. It starts with a description in the first two chapters of general clinical, neuroimaging and genetic data about glioblastoma (WHO grade IV glioma), which is the most frequent and the most malignant primary tumour in adults. Despite the complex treatment which includes neurosurgery, radiotherapy and chemotherapy, survival of the patients usually is between 9 and 12 months. Moreover, the surgery is not able to cure the disease due to the specific infiltrative growth pattern of glioblastoma. Therefore, laboratory research is essential in order to find new molecular and cellular therapies for this lethal disease. After shortly reviewing the modern hypothesis regarding the origin of glioblastoma in the third chapter, namely the cancer stem cells hypothesis, the author describes step-by-step in the following chapters (Chapters 4-8) the most important in vitro and in vivo models of research in glioblastoma. Chapter 4 is dedicated to the first and the essential step in any research project on glioblastoma: how to obtain good quality glioblastoma samples, how to prepare the samples and how to store the samples long-term for subsequent research. Open surgery and the image-guided stereotactic technique are also described in this chapter. After obtaining the tumour samples, the next step is to initiate the primary cells cultures. These in vitro techniques (either serum conditioning cell cultures and tumour stem cells cultures) will be discussed in detail in Chapters 5 and 6. Usually the new molecules with antitumor activity are tested in vitro on both primary glioblastoma cells cultures but also on glioblastoma cells lines in order to obtain a better standardised results. The next chapter, Chapter 7 is dedicated to in vivo techniques, which are required for testing the anti-tumoural effect of the new molecules before starting with the clinical trials. The author describes in detail the techniques of stereotactic intracranial inoculation of glioblastoma cells (either glioblastoma cell lines or glioblastoma-derived tumour stem cells) and the main growth patterns of the intracranial glioblastoma xenografts obtained using these techniques. Another technique very useful for exploring in real time the migratory glioblastoma cells is the organotypic brain slice cultures which is described in the last chapter of the book.

This book is a continuation of the book "Medicine Researcher Biographical Sketches and Research Summaries" which compiles biographical sketches of top professionals in the field of medicinal research, as well as research summaries from a number of different focuses in this important field.'

Cardiovascular disease refers to the class of diseases that involve the heart or blood vessels. While the term technically refers to any disease that affects the cardiovascular system, it is usually used to refer to those related to atherosclerosis. Chronic heart failure (CHF) has emerged as a major worldwide epidemic. This book gathers the latest research in cardiovascular disease with a focus on such topics as cardiac thrombus quantification in clinical practice; aspartate protease cathepsin D in liver and heart injury, pathophysiology and therapy; hypertension, arterial stiffness and cardiovascular outcomes; fractional flow reserve is an essential measure for the management of patients with stable coronary artery disease; arterial stiffness and vascular calcifications in chronic kidney disease patients; the clinical application of coronary flow velocity reserve by transthoracic Doppler echocardiography; management of right heart failure; short QT syndrome; new horizons in preventing graft arterial disease; and associations between cathepsin B and inflammation markers in elderly males and females.

This book details several important medicinal plants, their occurrence, plant compounds and their chemical structures, and pharmacological properties against various human diseases. It also gives information on isolation and structural elucidation of phytocompounds, bio-assays, metabolomic studies, and therapeutical applications of plant compounds.

One of the first studies of an exciting new development in global biotechnology, this cutting edge text examines the extent of the transnational movements of tissues, stem cells, and expertise, in the developing governance framework of India.

Documenting the impact of local and global governance frames on the everyday conduct of research, this groundbreaking book traces the journey of 'spare' human embryos in IVF clinics to public and private laboratories engaged in isolating stem cells for potential therapeutic application. The discussion also examines the gender dimension as a potential site for exploitation in the sourcing of embryonic and other biogenic materials, and suggests that a moral economy has developed in which the ethical values of the global North support and encourage the donation of abundant and ethically 'neutral' embryos by the South.

This unique exploration is grounded in an empirical, multi-sited ethnographic study that takes a thoroughly comparative analysis of the ethical, religious and social issues in Europe, the United States, and organ donations already prevalent in India. In this theoretically-sensitive analysis, the authors use the resources of social anthropology and the social sciences in an innovative text which will appeal to postgraduates and professionals in the areas of STS studies, genetics, bioethics, and anthropology.

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Now in its sixth edition, this guide sets out international and standard practice and is an invaluable reference for medical and scientific editors and authors. Scholarly journals often quote this booklet as a guide in their instructions to authors. An invaluable reference for editors and authors Includes fully updated sections on metrication and SI units, symbols and nomenclature, layout of references and proof correction

The Synthetic Biology Handbook explains the major goals of the field of synthetic biology and presents the technical details of the latest advances made in achieving those goals. Offering a comprehensive overview of the current areas of focus in synthetic biology, this handbook: Explores the standardisation of classic molecular bioscience approaches Addresses the societal context and potential impacts of synthetic biology Discusses the use of legacy systems as tools for new product development Examines the design and construction of de novo cells and genetic codes Describes computational methods for designing genes and gene networks Thus, the Synthetic Biology Handbook provides an accurate sense of the scope of synthetic biology today. The handbook also affords readers with an opportunity to scrutinize the underlying science and decide for themselves what aspects of synthetic biology are most valuable to their research and practice.