Переходная рамка Intro RFO-N02 для Ford Focus 2, C-Max, Fusion, Fiesta (05+) S-Max, Transit, Galaxy (06+), Kuga 2/1DIN.
The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical «nuts and bolts» approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
This second edition of a popular textbook is thoroughly revised with around 25% new and updated content. It provides an introduction to both plasma physics and fusion technology at a level that can be understood by advanced undergraduates and graduate students in the physical sciences and related engineering disciplines. As such, the contents cover various plasma confinement concepts, the support technologies needed to confine the plasma, and the designs of ITER as well as future fusion reactors. With end of chapter problems for use in courses.
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.
“You have a real chance…” When Kate hears this, she knows that her dream of winning the winter horse trials could come true. But Christmas Eve brings an unexpected present to the stables, the mysterious midnight horse. Unluckily for Kate, his owner, Izzy, has entered the trials too – and Izzy needs to win.
Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.
Bill Willingham's hit series FABLES continues here, for the first time in hardcover. In the aftermath of the Adversary's attack on Fabletown, FABLES: THE DELUXE EDITION BOOK 5 follows Boy Blue on a mission of revenge as he uncovers the Adversary's true identity! Plus, the 2-part story of Jack's adventures in Hollywood and the one-shot story of Mowgli's return to Fabletown.Fables Deluxe Edition Book 5 includes issues 34-45 of the original series.
Bill Willingham's hit series FABLES continues here, for the first time in hardcover. In the aftermath of the Adversary's attack on Fabletown, FABLES: THE DELUXE EDITION: BOOK 5 follows Boy Blue on a mission of revenge as he uncovers the Adversary's true identity! Plus, the 2-part story of Jack's adventures in Hollywood and the one-shot story of Mowgli's return to Fabletown. "Fables: Deluxe Edition: Book 5" includes issues 34-45 of the original series.
Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.
A revised and updated edition of the bestselling «no-nonsense guide to beating the competition.»-Publisher's Weekly Becoming a Category of One reveals how extraordinary companies do what they do so well and gives you the tools and ideas to help your business emulate their success. Packed with real case studies and personal reflections from successful business leaders, it helps you apply the best practices of the best companies to set yourself apart from your competitors and turn your business into a market leader. Whether you run a multinational corporation or a two-person start-up company, the lessons you'll find here apply to any business. This Second Edition includes a new chapter on «tie breakers,» updated examples of today's category of one companies, and special contributions from business experts, bestselling authors, and CEOs on the future category of one business. Revised and updated to remain relevant to today's market conditions and new innovations A new edition of the bestselling title from the author of Indispensable and Work Like You're Showing Off Today's struggling economy puts even greater importance on the theory and practice of business differentiation This edition includes 20 percent new material; if you liked the original edition, you'll love this new Second Edition Reliable, proven advice that works for businesses of any size in any industry Now more than ever, you have to differentiate your business from the competition to succeed. Becoming a Category of One gives you the blueprint for building your own extraordinary business.
The guide to creating simplicity in your world and developing a discipline for life, now in a full-color, expanded edition One Word explains how to simplify your life and business by focusing on just ONE WORD for the entire year. The simplicity of choosing one word makes it a catalyst for life-change. Clutter and complexity lead to procrastination and paralysis, while simplicity and focus lead to success and clarity. By celebrated authors Dan Britton, Jimmy Page, and Jon Gordon, One Word That Will Change Your Life shows you how to cut through to the core of your intention for the next year. It offers an action plan and simple process to discover your word for the year. It also explains how your one word will impact the six dimensions of your life—mental, physical, emotional, relational, spiritual, and financial. This beautifully illustrated full-color Second Edition includes even more stories demonstrating the impact of embracing the One Word call to action. It explores the legacy of taking a focused approach to your life and outlines six new dimensions to the Action Plan. Includes additional material on developing the One Word for teams and families, specifically how a group of people can also have a One Word Demonstrates how to establish a simple, disciplined, and focused approach to the next year of your life Discover how to create simplicity in your world and develop a discipline for life through the power of One Word.