In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development (such as bioavailability/bioequivalence), bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems. Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia.

This book gathers the proceedings of the 2018 Abel Symposium, which was held in Geiranger, Norway, on June 4-8, 2018. The symposium offered an overview of the emerging field of "Topological Data Analysis". This volume presents papers on various research directions, notably including applications in neuroscience, materials science, cancer biology, and immune response. Providing an essential snapshot of the status quo, it represents a valuable asset for practitioners and those considering entering the field.

Oligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. The Handbook of Analysis of Oligonucleotides and Related Products is an essential reference manual on the practical application of modern and emerging analytical techniques for the analysis of this unique class of compounds. A strong collaboration among thirty leading analytical scientists from around the world, the book provides readers with a comprehensive overview of the most commonly used analytical techniques and their advantages and limitations in assuring the identity, purity, quality, and strength of an oligonucleotide intended for therapeutic use. Topics discussed include: Strategies for enzymatic or chemical degradation of chemically modified oligonucleotides toward mass spectrometric sequencing Purity analysis by chromatographic or electrophoretic methods, including RP-HPLC, AX-HPLC, HILIC, SEC, and CGE Characterization of sequence-related impurities in oligonucleotides by mass spectrometry and chromatography Structure elucidation by spectroscopic methods (IR, NMR, MS) as well as base composition and thermal melt analysis (Tm) Approaches for the accurate determination of molar extinction coefficient of oligonucleotides Accurate determination of assay values Assessment of the overall quality of oligonucleotides, including microbial analysis and determination of residual solvents and heavy metals Strategies for determining the chemical stability of oligonucleotides The use of hybridization techniques for supporting pharmacokinetics and drug metabolism studies in preclinical and clinical development Guidance for the presentation of relevant analytical information towards meeting current regulatory expectations for oligonucleotide therapeutics This resource provides a practical guide for applying state-of-the-art analytical techniques in research, development, and manufacturing settings.

Quality refers to the amount of the unpriced attributes contained in each unit of the priced attribute. Leffler, 1982 Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is. Pirsig, 2000 The continuous formulation of good practices and procedures across fields reflects the importance of the recognition and maintenance of "quality" for nearly every profession. The widespread introduction of point-of-care testing, centralization of activities in large core laboratories, and the increase in number and complexity of diagnostic testing worldwide has driven changes in the organization of laboratory diagnostics over the past decades. As such, laboratory diagnostics, continuously catching up to updated techniques and complex procedures, need to stay vigilant about safety and good practices adjustments. Although widely defined and quantified, the concept of quality is an intrinsic feature of the human psyche and decision making. Written to improve laboratory work, Quality Assurance in the Pathology Laboratory examines: Quality assurance of quantifiable methods applied in laboratory medicine and toxicology Quality aspects of emerging disciplines including personalized therapy and virtopsy Regulatory and logistic instrumentation that ensure quality in laboratory methods Professional education at the graduate and postgraduate levels Laboratory diagnostics substantially contributes to clinical decision making by providing valuable information for the screening, diagnosis, therapeutic monitoring, and follow-up of most-if not all-human disorders. Providing general insights into the quality assurance aspects of pathology and laboratory medicine, this book aids in improving laboratory work and, at the same time, shows the possibilities and limits of all logistic and legal tools related to quality issues.

Health Information Exchange: Navigating and Managing a Network of Health Information Systems, Second Edition, now fully updated, is a practical guide on how to understand, manage and make use of a health information exchange infrastructure, which moves patient-centered information within the health care system. The book informs and guides the development of new infrastructures as well as the management of existing and expanding infrastructures across the globe. Sections explore the reasons for the health information exchange (HIE) infrastructures, how to manage them, examines the key drivers of HIE, and barriers to their widespread use. In addition, the book explains the underlying technologies and methods for conducting HIE across communities as well as nations. Finally, the book explains the principles of governing an organization that chiefly moves protected health information around. The text unravels the complexities of HIE and provides guidance for those who need to access HIE data and support operations.

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

Measures of Interobserver Agreement and Reliability, Second Edition covers important issues related to the design and analysis of reliability and agreement studies. It examines factors affecting the degree of measurement errors in reliability generalization studies and characteristics influencing the process of diagnosing each subject in a reliability study. The book also illustrates the importance of blinding and random selection of subjects. New to the Second Edition New chapter that describes various models for methods comparison studies New chapter on the analysis of reproducibility using the within-subjects coefficient of variation Emphasis on the definition of the subjects' and raters' population as well as sample size determination This edition continues to offer guidance on how to run sound reliability and agreement studies in clinical settings and other types of investigations. The author explores two ways of producing one pooled estimate of agreement from several centers: a fixed-effect approach and a random sample of centers using a simple meta-analytic approach. The text includes end-of-chapter exercises as well as downloadable resources of data sets and SAS code.

This combination manual and DVD provides much-needed training on the proper handling of mice used in biomedical research. The DVD includes narrated video clips that demonstrate and describe each procedural technique. The manual contains handouts with color illustrations and descriptive text for each technique, including the purpose and application of the procedure, recommended skills, and necessary supplies. It can be used as a training resource and refresher for lab animal veterinarians, veterinary technicians, animal care staff, trainers, and research investigators and staff who work with mice.

'Medical technology is beneficial for well researched dangerous diseases. However, most symptoms that people bring to their primary care physician have no single clearly identifiable cause: investigations and drugs do more harm than good - and also waste resources - ' - Wilfrid Treasure Diagnosis and Risk Management in Primary Care teaches that adopting an evidence-based approach to primary care improves patient care and treatment outcomes. It demonstrates that brief clinical assessments, repeated if necessary, allow effective diagnosis while avoiding the costs and complications associated with more advanced testing. Adopting a fresh approach, this book sets consultation skills alongside evidence-based information by both itemising the specific techniques and facts that are needed in the consulting room, and providing detailed information on odds and likelihood ratios to quantify risk and deal with uncertainty. This book provides food for thought, and helps doctors develop communication skills that support their personal styles of consulting, encouraging a more traditional, intuitive treatment. It provides a map of the consultation and a compass to navigate through symptoms, signs and evidence - listening to their patients with one ear and, with the other, to the reflective inner voice of reason. General Practitioner Specialist Trainees and their teachers will find much of interest, as will established General Practitioners with an interest in maintaining traditional models of care. Undergraduate medical students and candidates for the MRCGP will find this an ideal reader for the clinical skills assessment. 'What a breath of fresh air to find an author capable of putting the patient back at the centre of the consultation and who is able to entertain at the same time as he informs and to stimulate critical reflection while nudging us in the direction of a rigorous approach to diagnosis, and the assessment and communication of risk.' From the foreword by Roger Jones

A reflection of the intense study of the effects of electromagnetic fields on living tissues that has taken place during the last decades, Advanced Electroporation Techniques in Biology and Medicine summarizes most recent experimental findings and theories related to permeabilization of biomembranes by pulsed electric fields. Edited by experts and including contributions from pioneers in the field, the book focuses on biophysical mechanisms of electroporation and applications of this phenomenon in biomedical research and medicine. The field of electroporation is now mature enough to move from journal pages to book covers. The book leads readers from the basics and history of electroporation, through mechanisms of membrane permeabilization in lipid bilayers and living cells, to electrically-mediated gene delivery and cancer therapy in animals and humans. This book is an interdisciplinary compilation intended broadly for biomedical and physical scientists, engineers, and clinicians. It can also be used as a textbook for students in advanced courses in biomedical engineering, molecular and cell biology, as well as in biophysics and clinical medicine.

Learn to understand, critically appraise, and apply research studies to evidence-based nursing practice! Understanding Nursing Research: Building an Evidence-Based Practice is a leading textbook of nursing research for evidence-based practice (EBP), identified as a competency in the 2021 AACN Essentials and a key emphasis the Next-Generation NCLEX(R) Examination (NGN). This updated and enhanced 8th edition gives you even sharper insights into critical appraisal of published studies for evidence-based nursing practice. Known for its authoritative content, its time-tested systematic approach, and its unique Research Example format - the new 8th edition of this bestselling textbook features updated content throughout, including current examples of high-quality studies, along with new Research/Evidence-Based Practice Tips boxes and enhanced use of tables, boxes, and illustrations for improved learning. Clear, step-by-step organization introduces the research process and critical appraisal skills, identified as a competency in the 2021 AACN Essentials and a key emphasis of the Next-Generation NCLEX(R) Examination (NGN). Strong focus on EBP helps you develop skills in appraising and applying published studies, demonstrating how to apply evidence to clinical practice. Authoritative content is written by pioneers and practitioners of nursing research who offer unique, firsthand insights into the field. Balanced coverage of qualitative and quantitative research shows how to approach published studies with an unbiased view of the researcher's methodology. Research Examples are updated with high-quality nursing research and quality improvement studies showing how to critically appraise the nursing literature. Critical Appraisal Guidelines boxes provide step-by-step guidance in critically appraising published research studies. Summary tables, illustrations, and boxes promote in-depth learning of processes and approaches for today's increasingly evidence-based clinical practice. Introduction to mixed-methods and outcomes research examines these increasingly popular methodologies in nursing research. NEW! Updated content throughout the book focuses on the most relevant, need-to-know information to help you understand the research and evidence-based practice (EBP) processes. NEW! Research / Evidence-Based Practice Tips provide expert advice to help you critically appraise published studies for application to clinical practice.

In recent years, high-density DNA microarrays have revolutionized biomedical research and drug discovery efforts by the pharmaceutical industry. Their efficacy in identifying and prioritizing drug targets based on their ability to confirm a large number of gene expression measurements in parallel has become a key element in drug discovery. Microarray Innovations: Technology and Experimentation examines the incredibly powerful nature of array technology and the ways in which it can be applied to understanding the genomic basis of disease. Explores a myriad of applications in use today This volume explores recent innovations in the microarray field and tracks the evolution of the major platforms currently used. The international panel of contributors presents a survey of the past five years' research and advancements in microarray methods and applications and their usage in drug discovery and biomedical research. The contributions discuss improvements in automation (array fabrication and hybridization), new substrates for printing arrays, platform comparisons and contrasts, experimental design, and data normalization and mining schemes. They also review epigenomic array studies, electronic microarrays, comparative genomic hybridization, microRNA arrays, and mutational analyzes. In addition, the book provides coverage of important clinical diagnostic arrays, protein arrays, and neuroscience applications. Examines improved methodologies As microarrays have evolved steadily over time from archetypical in-house complementary DNA (cDNA) arrays to robust commercial oligonucleotide platforms, there has been a migration to higher density biochips with increasing content and better analytical methodologies. This compendium summarizes the vast advances that have been made in this technology, highlighting the supreme advantages of microarray-based approaches in the field of biomedical research.

Through the use of practical examples and solutions, this timely "Fifth Edition "has been updated and expanded to provide the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly clinical trials and bioequivalence studies.

New to the "Fifth Edition":

Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery.

With extensively updated content and 21 new chapters, this text examines:

• quality and efficiency of drug target validation and potential drug compound selection
• reducing assay costs and improvement in assay technology
• data quality improvement
• trends in drug discovery
• how drug screening can minimize adverse drug effects
• recent advancements, including: high content screening; protein-protein interactions; high-throughput crystallization; lead optimization; chemoinformatics and microfluidics technologies; target validation by genomics, proteomics, and siRNA; structure-based drug design; automation; and medicinal chemistry

Concise, contemporary, and accessible to students with little-to-no prior knowledge of nursing theory, Theoretical Basis for Nursing, 6th Edition, clarifies the application of theory and helps students become more confident, well-rounded nurses. With balanced coverage of grand, middle range, and shared theories, this acclaimed, AJN Award-winning text is extensively researched and easy to read, providing an engaging, approachable guide to developing, analyzing, and evaluating theory in students' nursing careers. Updated content reflects the latest perspectives on clinical judgment, evidence-based practice, and situation-specific theories, accompanied by engaging resources that give students the confidence to apply concepts to their own practice.

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

• advances in international regulatory requirements, including ICH guidelines and harmonization
• a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
• the latest regulatory requirements for expediting new drug approvals
• strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

A precise, practical handbook, Clinical Laboratory Investigation and Psychiatry is an invaluable tool that explores day-to-day psychiatric practices and various situations that arise in the field of mental health. This unique and resourceful textbook is a must-have aid for front-line clinicians, psychiatrists, and other professionals working in the field of adult mental health.

This complete guide to clinical psychiatry:

• examines methods for improving patient care and clinical outcomes
• extensively investigates which blood samples and tests to consider when dealing with mental health patients
• illustrates the possible clinical outcomes and interprets them in an easy-to-access format
• deals with the complexities of patients under difficult circumstances
• guides clinicians through the proper use of the clinical laboratory

Culture and Meaning in Health Services Research is a practical guide to applying interpretive qualitative methods to pressing healthcare delivery problems. A leading medical anthropologist who has spent many years working in applied healthcare settings, Sobo combines sophisticated theoretical insights and methodological rigor with authentic, real-world examples and applications. In addition to clearly explaining the nuanced practice of ethnography and guiding the reader through specific methods that can be used in focus groups or interviewing to yield useful findings, Sobo considers the social relationships and power dynamics that influence field entry, data ownership, research deliverables, and authorship decisions. Crafted to communicate the importance of culture and meaning across the many disciplines engaged in health services research, this book is ideal for courses in such fields as public health and health administration, nursing, anthropology, health psychology, and sociology.

A compelling defense of hormone replacement therapy, exposing the faulty science behind its fall from prominence and empowering women to make informed decisions about their health. For years, hormone replacement therapy (HRT) was hailed as a miracle. Study after study showed that HRT, if initiated at the onset of menopause, could ease symptoms ranging from hot flashes to memory loss; reduce the risk of heart disease, Alzheimer's, osteoporosis, and some cancers; and even extend a woman's overall life expectancy. But when a large study by the Women's Health Initiative announced results showing an uptick in breast cancer among women taking HRT, the winds shifted abruptly, and HRT, officially deemed a carcinogen, was abandoned. Now, sixteen years after HRT was left for dead, Dr. Bluming, a medical oncologist, and Dr. Tavris, a social psychologist, track its strange history and present a compelling case for its resurrection. They investigate what led the public -- and much of the medical establishment -- to accept the Women's Health Initiative's often exaggerated claims, while also providing a fuller picture of the science that supports HRT. A sobering and revelatory read, Estrogen Matters sets the record straight on this beneficial treatment and provides an empowering path to wellness for women everywhere.

Industrial Tomography: Systems and Applications, Second Edition thoroughly explores the important techniques of industrial tomography, also discusses image reconstruction, systems, and applications. This book presents complex processes, including the way three-dimensional imaging is used to create multiple cross-sections, and how computer software helps monitor flows, filtering, mixing, drying processes, and chemical reactions inside vessels and pipelines. This book is suitable for materials scientists and engineers and applied physicists working in the photonics and optoelectronics industry or in the applications industries.

Now in its fourth edition, Fraud and Misconduct in Biomedical Research boasts an impressive list of contributors from around the globe and introduces a new focus for the book, transforming it from a series of monographs into a publication that will quickly become an essential textbook on all areas of research fraud and misconduct. Key features include: a comprehensive analysis of the historical aspects of research misconduct, with cases from across the world; an extended section on the detection of research misconduct, examining the roles of the peer review process, statistical analysis, and routine enhanced audit; a completely new section, 'The Way Forward', which looks at the role of national advisory bodies. Fraud and Misconduct in Biomedical Research strives to uncover the issues surrounding clinical research in order to raise awareness of unethical practice, open debate and express concerns. This book is internationally relevant; from anyone who is involved with biomedical research or has an interest in fraud and misconduct, to the recipients and beneficiaries of research, who are directly affected by unreliable research.

Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures.

This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients.

Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.

High throughput analysis plays a critical role in the pharmaceutical industry. The ever-shortening timelines and high costs of drug discovery and development have brought about the need for high throughput approaches to methods that are currently used in the industry. Written and edited by well-known contributors who remain active in this line of research, this book systematically describes high throughput analysis for the pharmaceutical industry, including advanced instrumentation and automated sample preparation. The text discusses various techniques, including HPLC, MALDI-MS, and LC-MS/MS methods, with an emphasis on the later stage of drug development, including pharmacokinetics.

Intelligent and adaptive techniques are rapidly being used in all stages of medical treatment, from the initial diagnosis to planning delivery and follow-up therapy.To realize the full potential of these techniques, developers and end users must understand both the underlying technology and the specifics of the medical application considered. Focusing on this growing area of interest, Intelligent and Adaptive Systems in Medicine clearly and concisely explains a range of adaptive and intelligent systems, highlighting their benefits and limitations with realistic medical examples.

Bringing together theory and practice, this volume describes the application of adaptive and intelligent control as well as intelligent systems in the diagnosis, planning, treatment, and follow up of diseases such as cancer. Each chapter presents a family of an intelligent and adaptive system, explains the techniques and algorithms behind these systems, and explores how to solve medical and biomedical problems using intelligent and adaptive systems. The book focuses on the methods of fuzzy logic, artificial neural networks, neuro-fuzzy modeling, adaptive and predictive control, systems and statistical modeling, and image processing.

By assessing the use of intelligent and adaptive techniques for medical diagnosis and therapy, this guide promotes further research in this area of "techno-medicine." It provides researchers and clinicians with the tools and processes that are leading to the invaluable use of intelligent systems in early diagnoses and effective treatment.

Although longitudinal social network data are increasingly collected, there are few guides on how to navigate the range of available tools for longitudinal network analysis. The applied social scientist is left to wonder: Which model is most appropriate for my data? How should I get started with this modeling strategy? And how do I know if my model is any good? This book answers these questions. Author Scott Duxbury assumes that the reader is familiar with network measurement, description, and notation, and is versed in regression analysis, but is likely unfamiliar with statistical network methods. The goal of the book is to guide readers towards choosing, applying, assessing, and interpreting a longitudinal network model, and each chapter is organized with a specific data structure or research question in mind. A companion website includes data and R code to replicate the examples in the book.