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This volume is a collection of articles on reliability systems and Bayesian reliability analysis. Written by reputable researchers, the articles are self-contained and are linked with literature reviews and new research ideas. The book is dedicated to Emeritus Professor Richard E Barlow, who is well known for his pioneering research on reliability theory and Bayesian reliability analysis. Contents: System Reliability Analysis: On Regular Reliability Models (J-C Chang et al.); Bounding System Reliability (J N Hagstrom & S M Ross); Large Excesses for Finite-State Markov Chains (D Blackwell); Ageing Properties: Nonmonotonic Failure Rates and Mean Residual Life Functions (R C Gupta); The Failure...
The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical d...
The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analyses such as the Bayesian approach are essential to meet this need. This book will be the first to provide comprehensive coverage of Bayesian applications across the span of drug development, from discovery, to clinical trial, to manufacturing with practical examples. This book will have a wide appeal to statisticians, scientists, and physicians working in drug development who are motivated to accelerate and streamline the drug development process,...
Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a...
As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital ...
Statistical Methods in Healthcare In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods...
First published in 1993. Routledge is an imprint of Taylor & Francis, an informa company.
Dr. Rothstein has assembled top experts to present the current status of the role of endoscopy in managing the obese patient. Authors present current clinical information on the following topics: Small Bowel Target Devices and Techniques; Reimbursement Issues for Endoscopic Devices Used for Metabolic Endoscopy; the Physiologic Alteractions of Bariatric Surgery; Non-Balloon Gastric and Pyloric Therapies for Obesity; Aspiration Therapy for Obesity; Endoscopic Therapies after Surgery; Duodenal Mucosal Resurfacing: Role for Diabetes Treatment; Gastric Plication; and Gastric Balloons. Readers should come away with the information they need to utilize endoscopic techniques to improve outcomes in their patients.