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Author : Wayne A. Taylor
Publisher :
ISBN 13 : 9780963512291
Total Pages : 0 pages
Book Rating : 4.93/5 ( download)
Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David J. Smith
Publisher : CRC Press
ISBN 13 : 1000469581
Total Pages : 91 pages
Book Rating : 4.85/5 ( download)
Download or read book Basic Statistical Techniques for Medical and Other Professionals written by David J. Smith and published by CRC Press. This book was released on 2021-10-25 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: We are bombarded with statistical data each and every day, and healthcare professionals are no exception. All sectors of healthcare rely on data provided by insurance companies, consultants, research firms, and government to help them make a host of decisions regarding the delivery of medical services. But while these health professionals rely on data, do they really make the best use of the information? Not if they fail to understand whether the assumptions behind the formulas generating the numbers make sense. Not if they don’t understand that the world of healthcare is flooded with inaccurate, misleading, and even dangerous statistics. The purpose of this book is to provide members of medical and other professions, including scientists and engineers, with a basic understanding of statistics and probability together with an explanation and worked examples of the techniques. It does not seek to confuse the reader with in-depth mathematics but provides basic methods for interpreting data and making inferences. The worked examples are medically based, but the principles apply to the analysis of any numerical data.
Author : Scott A. Pardo
Publisher : Springer Nature
ISBN 13 : 3031261399
Total Pages : 384 pages
Book Rating : 4.98/5 ( download)
Download or read book Statistical Methods and Analyses for Medical Devices written by Scott A. Pardo and published by Springer Nature. This book was released on 2023-04-24 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a reference for people working in the design, development, and manufacturing of medical devices. While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes. While, there are no statistical methods specifically designed for analysis of medical device data, there are some methods that seem to appear regularly in relation to medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example. This book is for those with no statistical experience, as well as those with statistical knowledgeable—with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.
Author : Glenn Walker
Publisher : SAS Institute
ISBN 13 : 1607644258
Total Pages : 553 pages
Book Rating : 4.55/5 ( download)
Download or read book Common Statistical Methods for Clinical Research with SAS Examples, Third Edition written by Glenn Walker and published by SAS Institute. This book was released on 2010-02-15 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: Glenn Walker and Jack Shostak's Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is a thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED. Straightforward and easy to use as either a text or a reference, the book is full of practical examples from clinical research to illustrate both statistical and SAS methodology. Each example is worked out completely, step by step, from the raw data. Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is an applications book with minimal theory. Each section begins with an overview helpful to nonstatisticians and then drills down into details that will be valuable to statistical analysts and programmers. Further details, as well as bonus information and a guide to further reading, are presented in the extensive appendices. This text is a one-source guide for statisticians that documents the use of the tests used most often in clinical research, with assumptions, details, and some tricks--all in one place. This book is part of the SAS Press program.
Author : Richard J. Cook
Publisher : Springer Science & Business Media
ISBN 13 : 0387698094
Total Pages : 415 pages
Book Rating : 4.90/5 ( download)
Download or read book The Statistical Analysis of Recurrent Events written by Richard J. Cook and published by Springer Science & Business Media. This book was released on 2007-08-02 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents models and statistical methods for the analysis of recurrent event data. The authors provide broad, detailed coverage of the major approaches to analysis, while emphasizing the modeling assumptions that they are based on. More general intensity-based models are also considered, as well as simpler models that focus on rate or mean functions. Parametric, nonparametric and semiparametric methodologies are all covered, with procedures for estimation, testing and model checking.
Author : Walter A. Shewhart
Publisher : Courier Corporation
ISBN 13 : 048617087X
Total Pages : 178 pages
Book Rating : 4.79/5 ( download)
Download or read book Statistical Method from the Viewpoint of Quality Control written by Walter A. Shewhart and published by Courier Corporation. This book was released on 2012-07-31 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Important text offers lucid explanation of how to regulate variables and maintain control over statistics in order to achieve quality control over manufactured products, crops and data. First inexpensive paperback edition.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.60/5 ( download)
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.38/5 ( download)
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author : Frederick Faltin
Publisher : Wiley
ISBN 13 : 9780470670156
Total Pages : 520 pages
Book Rating : 4.50/5 ( download)
Download or read book Statistical Methods in Healthcare written by Frederick Faltin and published by Wiley. This book was released on 2012-10-01 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated, case-study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern Statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.
Author : Manuel E. Pena-Rodriguez
Publisher : Quality Press
ISBN 13 : 0873898524
Total Pages : 205 pages
Book Rating : 4.22/5 ( download)
Download or read book Statistical Process Control for the FDA-Regulated Industry written by Manuel E. Pena-Rodriguez and published by Quality Press. This book was released on 2013-04-11 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the authors almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
