Медицина
Различные книги в жанре МедицинаCompatibility of Pharmaceutical Solutions and Contact Materials. Safety Assessments of Extractables and Leachables for Pharmaceutical Products
Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of «what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?» and «when do the various required activities need to be performed?» Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
Concepts in Male Health. Perspectives Across The Lifespan
Concepts in Male Health Concepts in Male Health: Perspectives Across the Lifespan offers a practical approach to understanding the health of males of all races, ethnicities, socioeconomic status, cultures, ages, and orientations. Each chapter of this book comprehensively reviews an important dimension of male health and examines the contributing historical, epidemiological,??psychosocial, cultural-ethical, legal, political, and economic influences. The diverse range of topics allows for complete coverage ranging from body structures??and sexuality to aggression and occupational health. ??The book contains the most recent research and evidence-based science and addresses issues in male health throughout the lifespan in an easy-to-understand format. ??Learning objectives are presented in an accessible format and reflect real life situations. Review questions provided at the end of each chapter address health-specific content included in the chapter and span both the scope and the breadth of the information. This book is ideal for programs in health education, public health, community health nursing, gender studies, and other health sciences.
Pharmaceutical Anti-Counterfeiting. Combating the Real Danger from Fake Drugs
This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.
Value Based Health Care. Linking Finance and Quality
Value-Based Health Care Linking Finance and Quality Yosef D. Dlugacz Value-Based Health Care? Value-Based Health Care?concisely explains the mandate to successfully link health care quality and finance and describes the tools to implement strategies for organizational success. Yosef Dlugacz provides many illustrative real-world examples of process and outcomes of the value-based approach, taken from a wide range of health care settings. Perfect for students preparing to enter health care management or for practicing health care leaders and professionals, this book is a vital guide to approaches that ensure the health of patients and health care organizations alike. Praise for Value-Based Health Care «Value-Based Health Care provides leaders and quality experts with the much needed roadmap for linking cost and quality. This book will help your organization thrive in today's ultra-competitive environment.» —Patrice L. Spath, health care quality specialist and author of Leading Your Health Care Organization to Excellence and Error Reduction in Health Care: A Systems Approach to Improving Patient Safety «Yosef Dlugacz provides an essential overview of how staff, administrators, and clinicians can create not just a culture but a gestalt of quality health care delivery. . . .given the national debate over access, cost, and quality, the book could not be more timely.» —Theodore J. Joyce, PhD, professor of economics and finance, academic director of the Baruch/Mt. Sinai MBA Program in Health Care Administration, and research associate, National Bureau of Economic Research «Dr. Dlugacz's?case studies and action plans provide great insights and workable solutions to provide safe and effective patient care. It is a welcome resource as we sit on the?advent of health reform.» —Kathy Ciccone, executive director, Quality Institute of the Healthcare Association of New York State
BACE. Lead Target for Orchestrated Therapy of Alzheimer's Disease
BACE inhibitors and their use in the treatment of Alzheimer's Disease BACE (β-site of APP cleaving enzyme) is a critical component in Alzheimer's Disease (AD), and the development of BACE inhibitors shows great potential as a therapy for the disease. BACE: Lead Target for Orchestrated Therapy of Alzheimer's Disease covers virtually all aspects of BACE from initial identification, discovery of inhibitors, and challenges in clinical development, while providing a global understanding essential for productive and successful drug discovery. This book details the story of the discovery of BACE and its role in AD and comprehensively discusses: The development of BACE inhibitors as therapeutics for Alzheimer's disease The research that led to the identification of BACE New BACE inhibitors currently being clinically tested ADME (absorption, distribution, metabolism, excretion) and clinical trial design—topics not addressed in current field literature Cutting-edge technology such as high-throughput screening, structure-based drug design, and QSAR in context of BACE inhibitors and Alzheimer's drug discovery Other approaches to BACE inhibition based on interaction with the precursor protein APP By enhancing the reader's understanding of the various aspects of the BACE drug-discovery process, this much-needed reference will serve as a key resource for all scientists involved in Alzheimer's research—and inspire new approaches to treatment of AD.
Public Health Policy. Issues, Theories, and Advocacy
Public Health Policy: Issues, Theories, and Advocacy offers students an engaging and innovative introduction to public health policy: its purpose, how it is originated, and how it is implemented. The book describes the underlying theories and frameworks as well as practical analytical tools needed for effective advocacy and communication. Drawing on the multidisciplinary nature of public health, the book uses concepts and examples from epidemiology, law, economics, political science, and ethics to examine the policymaking process, explain positions pro or con, and develop materials for various audiences to further a public health policy intervention. In addition, Public Health Policy shows how policymaking is a complex and integrated top-down and bottoms-up process that embraces a myriad of public and private stakeholders. Written by a highly experienced health policy researcher and teacher, the book is rich in resources that will enhance teaching and learning. Each chapter begins with an overview of the chapter, including core terms and concepts, and includes illustrative examples of how the highlighted component (law, ethics, economics, politics, epidemiology, and medicine) intersects with public health. Discussion questions at the end of every chapter, along with an interview from an expert from each of the component fields, give real-world perspectives on how that particular subject relates to the overall topic. The book also contains 13 case studies that illustrate the framework discussed in the first part of the book, and show how the different components link to create, sustain, evaluate, or obstruct the development of public health policy. Also included are primers on two essential policy tools: how to write research policy briefs, and how to craft effective letters to an editor, including examples of both drawn from the author's publications in journals and newspapers.
Cost-Contained Regulatory Compliance. For the Pharmaceutical, Biologics, and Medical Device Industries
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Lyme Borreliosis in Europe and North America. Epidemiology and Clinical Practice
The facts about Lyme disease, from epidemiology to treatment to control Lyme borreliosis, popularly known as Lyme disease, remains the most commonly reported tick-transmitted infection in North America and Europe. A growing body of scientific and clinical evidence has facilitated early diagnosis and effective treatment. Nonetheless, there are a number of misconceptions about this infectious disease that have given rise to unproven, potentially dangerous alternative therapies. In Lyme Borreliosis in Europe and North America, a team of authors whose expertise spans basic research, epidemiology, and clinical practice has compiled evidence-based information on Lyme borreliosis. Presents all the latest evidence needed to diagnose, treat, and prevent Lyme disease Lyme Borreliosis in Europe and North America begins with a review of the disease's epidemiology, the causative Borrelia genospecies, and tick vectors. It then explores pathogenesis, diagnosis, and treatment. Next, the book examines the role of serologic, culture, and molecular diagnostic methods. The book also features a chapter on prognosis, offering an evidence-based review of outcome studies, as well as practical advice to physicians to help them manage the challenging clinical scenario of chronic symptoms attributed to Borrelia infection. The final chapter is a guide to prevention strategies, including the management of tick bites. Examines similarities and differences in Europe and North America Because differences in Borrelia genospecies are responsible for differences in the clinical presentation of Lyme borreliosis between North America and Europe, this book provides descriptions of the disease as it presents on each continent. Most of the chapters have been cowritten by experts on each continent, in order to provide a balanced perspective that combines European and North American findings, practices, and experiences. Helps everyone better understand, treat, and control Lyme disease Lyme Borreliosis in Europe and North America is a comprehensive reference, ideal for clinicians, researchers, and public health officials who seek to treat and control Lyme borreliosis. It will help them better understand the facts and make sense of the misconceptions and myths that surround this infectious disease.
Error Reduction in Health Care. A Systems Approach to Improving Patient Safety
Error Reduction in Health Care Completely revised and updated, this second edition of Error Reduction in Health Care offers a step-by-step guide for implementing the recommendations of the Institute of Medicine to reduce the frequency of errors in health care services and to mitigate the impact of errors when they do occur. With contributions from noted leaders in health safety, Error Reduction in Health Care provides information on analyzing accidents and shows how systematic methods can be used to understand hazards before accidents occur. In the chapters, authors explore how to prioritize risks to accurately focus efforts in a systems redesign, including performance measures and human factors. This expanded edition covers contemporary material on innovative patient safety topics such as applying Lean principles to reduce mistakes, opportunity analysis, deductive adverse event investigation, improving safety through collaboration with patients and families, using technology for patient safety improvements, medication safety, and high reliability organizations. The Editor
Emerging Infectious Diseases. A Guide to Diseases, Causative Agents, and Surveillance
Emerging Infectious Diseases offers an introduction to emerging and reemerging infectious disease, focusing on significant illnesses found in various regions of the world. Many of these diseases strike tropical regions or developing countries with particular virulence, others are found in temperate or developed areas, and still other microbes and infections are more indiscriminate. This volume includes information on the underlying mechanisms of microbial emergence, the technology used to detect them, and the strategies available to contain them. The author describes the diseases and their causative agents that are major factors in the health of populations the world over. The book contains up-to-date selections from infectious disease journals as well as information from the Centers for Disease Control and Prevention, the World Health Organization, MedLine Plus, and the American Society for Microbiology. Perfect for students or those new to the field, the book contains Summary Overviews (thumbnail sketches of the basic information about the microbe and the associated disease under examination), Review Questions (testing students' knowledge of the material), and Topics for Further Discussion (encouraging a wider conversation on the implications of the disease and challenging students to think creatively to develop new solutions). This important volume provides broad coverage of a variety of emerging infectious diseases, of which most are directly important to health practitioners in the United States.