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.

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

This book examines developments in qualitative psychotherapeutic research. It focuses on different methods and aspects of clinical practice. These range from the experiences of service users and clinicians, examining in detail different aspects of how therapy gets done in practice, to critiquing the politics and ideologies of psychotherapy practice. It aims to reflect the diversity that characterises this developing field and to represent practice-based research carried out in different clinical settings, from different perspectives and in different sociocultural contexts. The wide range of research projects presented arise from a network of clinicians and psychotherapy researchers who have established an international transdisciplinary forum for dedicated qualitative research on a range of topics in the field of mental health, using a variety of methodologies and theoretical approaches. In the spirit of dialogue, this book further provides chapters written by key practitioners in the field of qualitative research in mental health discussing these contributions. This book was originally published as a special issue of the European Journal of Psychotherapy & Counselling.

Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies. The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference. This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.

Computational Intelligence in Healthcare Applications discusses a variety of techniques designed to represent, enhance and empower inter-domain research based on computational intelligence in healthcare. The book serves as a reference for the pervasive healthcare domain which takes into consideration new convergent computing and other applications. The book discusses topics such as mathematical modeling in medical imaging, predictive modeling based on artificial intelligence and deep learning, smart healthcare and wearable devices, and evidence-based predictive modeling. In addition, it discusses computer-aided diagnostic for clinical inferences and pervasive and ubiquitous techniques in healthcare. This book is a valuable resource for graduate students and researchers in medical informatics, however, it is also ideal for members of the biomedical field and healthcare industry who are interested in learning more about novel technologies and their applications in the field.

Covering all major arthropods of medical importance worldwide, this award-winning resource has established itself as a standard reference for almost 25 years. With the globilization of commerce and the world becoming more intimately connected through the everyday ease of travel, unknown arthropod species are being increasingly encountered. This means access to up-to-date, authoritative information in medical entomology has never been more important. Now in its seventh edition, this book maintains its well-acclaimed status as the ultimate easy-to-use guide to identify disease-carrying arthropods, the common signs and symptoms of vector-borne diseases, and the current recommended procedures for treatment. Includes an in-depth chapter with diagnostic aids to help physicians to recognize and accurately diagnose arthropod-related diseases and conditions more easily Updates all chapters with the latest medical and scientific findings, including Zika virus, red meat allergy, new viruses found in ticks, and vaccine development for malaria and dengue fever Presents a greater medical parasitology emphasis throughout Offers electronic downloads containing additional photographs of arthropod-caused diseases and lesions, as well as instructional videos with pest identification aids, basic entomology, and insect and pest ecology. Illustrated throughout with detailed color images to aid identification, The Goddard Guide to Arthropods of Medical Importance, Seventh Edition will remain an essential guide for physicians, public health officials, and pest control professionals.

Anna Tarrant's revealing research explores the dynamics of men's caring responsibilities in low-income families' lives. The book draws on pioneering multigenerational research to examine men's involvement in care for their families. It interrogates how this is affected by the resources available and the constraints upon them, considering intersections of gender, generation and work, as well as the impact of austerity and welfare support. Illuminating aspects of care within economic hardship that often go unseen, it deepens our understanding of masculinities and family life and the policies and practices that support or undermine men's participation.

The newer research areas in pharmaceutical sciences, particularly molecular modeling and simulations, prompted a more efficient drug discovery process. Informatics integrated with pharmaceutical sciences (cheminformatics and bioinformatics) became an essential component of drug research. Drug informatics such as genomics and proteomics assists in the Rational Drug Design (RDD). This emerging discipline is known as "Computer-Aided Drug Design" (CADD), which has profound application in RDD. The advanced and adequate practice in drug design informatics is essential for pharmacy graduates. Hence, a companion for acquiring knowledge on these concepts is vital. The students of B. Pharmacy, M. Pharmacy (Pharmaceutical Chemistry, Pharmacology, and Pharmaceutics), biotechnology, biomedical engineering and other interdisciplinary fields may find this book as a reference guide. The salient features of this book are: * Systematic and simple approach * Emphasis on traditional and modern drug design strategies * Comprehensive coverage for the current advances in the drug design * Experimental section to ensure hands-on-experience Note: T& F does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka.

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary. Grounded in practicality, the book's applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig s origins, anatomy, genetics, immunology, and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. Regulatory aspects of its use are considered.

The reader will find an extensive amount of theoretical and practical information in the pharmacology; ADME and toxicology chapters which will help scientists and managers when deciding which species to use in basic research; drug discovery and pharmacology; and toxicology studies of chemicals, biotechnology products and devices. The book discusses regulatory uses of minipigs in the evaluation of human and veterinary pharmaceuticals, medical devices, and other classes of xenobiotics. It describes features of normal health, normal laboratory values, and common diseases. It also carefully elucidates ethical and legal considerations in their supply, housing, and transport. The result is an all-inclusive and up to date manual about the experimental uses of the minipig that describes How to and Why and What to expect in the normal, combining enthusiasm and experience with critical assessment of its values and potential problems."

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Cross-sectoral interaction and cooperation in the communication of nutritional health risks represents a strategic research area among national governments and international health authorities. The key research question this book addresses is whether and how different industrial sectors interact with each other in the communication and industrial utilisation of health research findings. Through the introduction and exploration of large-scale industry news and digital media resources, this book systematically analyses a range of digital news genres and identifies new and growing trends of inter-sectoral interaction around the communication of nutritional health in the Chinese language at both international and national levels. This book argues that cross-sectoral interaction can be explored to identify areas that require policy intervention to increase the efficiency and effectiveness of current health communication and promotion. Inter-sectoral interaction can also provide incentives to develop new social programmes and business models to innovate and transform traditional industrial sectors.

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood Glucose Monitoring Atomic Force Microscopy Parenteral Infusion Devices Clinical Laboratory: Separation and Spectral Methods Clinical Laboratory: Nonspectral Methods and Automation Noninvasive Optical Monitoring An offshoot from the definitive "bible" of biomedical engineering, Medical Instruments and Devices: Principles and Practices offers you state-of-the-art information on biomedical instruments and devices. This text serves practicing professionals working in the areas of medical devices and instrumentation as well as graduate students studying bioengineering, instrumentation, and medical devices, and it provides readers with a practical foundation and a wealth of resources from well-known experts in the field.

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.

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.

This is the first book that comprehensively and systematically describes the new technology of hydrophilic interaction liquid chromatography (HILIC). Hydrophilic interaction chromatography is a separation technique suitable for polar and hydrophilic compounds and orthogonal to reversed phase liquid chromatography. From small organic molecules to proteins, the text explores the many applications of HILIC in the analytical field. Winner of the President's Award for Excellence, the author explains how HILIC can significantly improve analytical throughput by shortening sample preparation procedure, which is one of the bottlenecks for drug discovery and development in the pharmaceutical industry.

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.

The development of modern civilization leads to us having to solve new problems which did not exist before. The contemporary world faces a great challenge of aging societies, where the increasing number of citizens requires constant medical attention. To ensure safety and wellbeing of elderly people, patients in hospitals and disabled persons, advanced technologies can be implemented. These include both sophisticated data acquisition systems and data processing algorithms, aiming at the constant and discreet monitoring of persons whilst raising alarm if immediate attention is required. Computer Systems for Healthcare and Medicine presents a novel look at the introduced problems, including proposed solutions in the form of automated data acquisition and processing systems, which were tested in various environments. Characteristic features include a wide range of sensors used to monitor the situation of the person, and accurate decision making algorithms, often based on the computational intelligence domain. Technical topics discussed in the book include application for the healthcare of the following: * Infrared sensors * MEMS * Ultra wideband radars * Deep learning * Decision trees * Artificial neural networks * Gabor filters * Decision support systems

Connected Health is the most dynamic phenomenon in healthcare technology today. From smartphones and tablets to apps, body sensors and telemedicine, Connected Health promises to stir foundational shifts in healthcare quality and delivery. This is a watershed moment in healthcare - the Connected Health ecosystem is dramatically impacting healthcare's stakeholders, from patients to C-Suite executives, and is delivering on the tri aim: quality care, coordination and cost savings. This new book conducts a focused examination of wearables as an explosive niches of the Connect Health market. Covering a range of issues from wearable applications in the consumer and provider spaces, to emerging technology solutions and hurdles to successful deployment, this book also provides an engaging discussion about wearables as a change agent of healthcare delivery. The discussion continues with and examination of the interplay between solutions like wearables in the Healthcare Internet of Things ("IoT") landscape. The book also explores the scope and trajectory of the Connected Health ecosystem through a combination of expert commentary and selected case studies. It serves as an educational resource as well as a practical guide in strategizing and executing a Connected Health market and product strategy.

Connected Health is the most dynamic phenomenon in healthcare technology today. From smartphones and tablets to apps, body sensors and telemedicine, Connected Health promises to stir foundational shifts in healthcare quality and delivery. This is a watershed moment in healthcare - the Connected Health ecosystem is dramatically impacting healthcare's stakeholders, from patients to C-Suite executives, and is delivering on the tri aim: quality care, coordination and cost savings. This new book conducts a focused examination of wearables as an explosive niches of the Connect Health market. Covering a range of issues from wearable applications in the consumer and provider spaces, to emerging technology solutions and hurdles to successful deployment, this book also provides an engaging discussion about wearables as a change agent of healthcare delivery. The discussion continues with and examination of the interplay between solutions like wearables in the Healthcare Internet of Things ("IoT") landscape. The book also explores the scope and trajectory of the Connected Health ecosystem through a combination of expert commentary and selected case studies. It serves as an educational resource as well as a practical guide in strategizing and executing a Connected Health market and product strategy.

This book is dedicated to the field of conductive polymers, focusing on electrical interactions with biological systems. It addresses the use of conductive polymers as the conducting interface for electrical communications with the biological system, both in vitro and in vivo. It provides an overview on the chemistry and physics of conductive polymers, their useful characteristics as well as limitations, and technologies that apply conductive polymers for medical purposes. This groundbreaking resource addresses cytotoxicity and tissue compatibility of conductive polymers, the basics on electromagnetic fields, and commonly used experimental methods. Readers will also learn how cells are cultured in vitro with conductive polymers, and how conductive polymers and living tissues interact electrically. Throughout the contents, chapter authors emphasize the importance of conductive polymers in biomedical engineering and their potential applications in medicine.

This book covers the broad field of cellular, molecular, preclinical, and clinical imaging either associated with or combined with photodynamic therapy (PDT). It showcases how this approach is used clinically for cancer, infections, and diseases characterized by unwanted tissue such as atherosclerosis or blindness. Because the photosensitizers are also fluorescent, the book also addresses various imaging systems such as confocal microscopy and small animal imaging systems, and highlights how they have been used to follow and optimize treatment, and to answer important mechanistic questions. Chapters also discuss how imaging has made important contributions to clinical outcomes in skin, bladder, and brain cancers, as well as in the development of theranostic agents for detection and treatment of disease. This book provides a resource for physicians and research scientists in cell biology, microscopy, optics, molecular imaging, oncology, and drug discovery.

The book provides an insight into the advantages and limitations of the use of fractals in biomedical data. It begins with a brief introduction to the concept of fractals and other associated measures and describes applications for biomedical signals and images. Properties of biological data in relations to fractals and entropy, and the association with health and ageing are also covered. The book provides a detailed description of new techniques on physiological signals and images based on the fractal and chaos theory. The aim of this book is to serve as a comprehensive guide for researchers and readers interested in biomedical signal and image processing and feature extraction for disease risk analyses and rehabilitation applications. While it provides the mathematical rigor for those readers interested in such details, it also describes the topic intuitively such that it is suitable for audience who are interested in applying the methods to healthcare and clinical applications. The book is the outcome of years of research by the authors and is comprehensive and includes other reported outcomes.

ASCP requirement. "To pass the ASCP and become a licensed medical lab tech, this text is the ultimate blood bank source for the required classes." - Amazon Reviewer "Great resource for anyone in a Medical Technology or Medical Laboratory Science Program! I would highly recommend this book!" - Mary L., Amazon Reviewer "Amazing legendary book in the field. Helpful for practicing Transfusion Medicine and Hematology." - Zubair S., Amazon Reviewer Join the generations of students who have embarked on successful careers with a firm foundation in the theory and practice of blood banking and transfusion practices. Denise Harmening's classic text teaches you not only how to perform must-know tests and tasks, but to understand the scientific principles behind them. You'll begin with a review of the basic concepts of red blood cell and platelet preservation, genetics, immunology, and molecular biology. Then you'll move to the hows and whys of clinical practice. And, you'll be prepared for new advances in the field.