Statistical Methods And Analyses For Medical Devices

Author : Scott A. Pardo
Publisher : Springer Nature
Page : 384 pages
File Size : 41,6 Mb
Release : 2023-04-24
Category : Mathematics
ISBN : 9783031261398

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Statistical Methods and Analyses for Medical Devices by Scott A. Pardo Pdf

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 : Frederick W. Faltin,Ron S. Kenett,Fabrizio Ruggeri
Publisher : John Wiley & Sons
Page : 533 pages
File Size : 54,9 Mb
Release : 2012-07-24
Category : Medical
ISBN : 9781119942047

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Statistical Methods in Healthcare by Frederick W. Faltin,Ron S. Kenett,Fabrizio Ruggeri Pdf

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 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 : Wayne A. Taylor
Publisher : Unknown
Page : 0 pages
File Size : 42,5 Mb
Release : 2017
Category : Electronic
ISBN : 0963512293

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Statistical Procedures for the Medical Device Industry by Wayne A. Taylor Pdf

Author : Jie Chen,Joseph Heyse,Tze Leung Lai
Publisher : CRC Press
Page : 220 pages
File Size : 45,7 Mb
Release : 2018-09-03
Category : Mathematics
ISBN : 9781351021968

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Medical Product Safety Evaluation by Jie Chen,Joseph Heyse,Tze Leung Lai Pdf

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

Author : Ying Lu,Ji-Qian Fang
Publisher : World Scientific
Page : 1118 pages
File Size : 42,9 Mb
Release : 2003
Category : Medical
ISBN : 9810248008

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Advanced Medical Statistics by Ying Lu,Ji-Qian Fang Pdf

This book presents new and powerful advanced statistical methods that have been used in modern medicine, drug development, and epidemiology. Some of these methods were initially developed for tackling medical problems. All 29 chapters are self-contained. Each chapter represents the new development and future research topics for a medical or statistical branch. For the benefit of readers with different statistical background, each chapter follows a similar style: the explanation of medical challenges, statistical ideas and strategies, statistical methods and techniques, mathematical remarks and background and reference. All chapters are written by experts of the respective topics.

Author : British Standards Institute Staff
Publisher : Unknown
Page : 16 pages
File Size : 55,6 Mb
Release : 2003-03-28
Category : Electronic
ISBN : 0580415104

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Sampling Procedures Used for Acceptance Testing of in Vitro Diagnostic Medical Devices. Statistical Aspects by British Standards Institute Staff Pdf

Sampling methods, Approval testing, Acceptance (approval), Clinical investigation instruments, Statistics, Statistical methods of analysis, Medical equipment, Diagnosis (medical), Process control, Homogeneity, Certification (approval), Quality assurance

Author : Shen Liu,James Mcgree,Zongyuan Ge,Yang Xie
Publisher : Academic Press
Page : 206 pages
File Size : 46,7 Mb
Release : 2015-11-20
Category : Mathematics
ISBN : 9780081006511

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Computational and Statistical Methods for Analysing Big Data with Applications by Shen Liu,James Mcgree,Zongyuan Ge,Yang Xie Pdf

Due to the scale and complexity of data sets currently being collected in areas such as health, transportation, environmental science, engineering, information technology, business and finance, modern quantitative analysts are seeking improved and appropriate computational and statistical methods to explore, model and draw inferences from big data. This book aims to introduce suitable approaches for such endeavours, providing applications and case studies for the purpose of demonstration. Computational and Statistical Methods for Analysing Big Data with Applications starts with an overview of the era of big data. It then goes onto explain the computational and statistical methods which have been commonly applied in the big data revolution. For each of these methods, an example is provided as a guide to its application. Five case studies are presented next, focusing on computer vision with massive training data, spatial data analysis, advanced experimental design methods for big data, big data in clinical medicine, and analysing data collected from mobile devices, respectively. The book concludes with some final thoughts and suggested areas for future research in big data. Advanced computational and statistical methodologies for analysing big data are developed Experimental design methodologies are described and implemented to make the analysis of big data more computationally tractable Case studies are discussed to demonstrate the implementation of the developed methods Five high-impact areas of application are studied: computer vision, geosciences, commerce, healthcare and transportation Computing code/programs are provided where appropriate

Author : A. Lawrence Gould
Publisher : John Wiley & Sons
Page : 392 pages
File Size : 46,8 Mb
Release : 2014-12-08
Category : Medical
ISBN : 9781118763094

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Statistical Methods for Evaluating Safety in Medical Product Development by A. Lawrence Gould Pdf

This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Author : Peter Armitage,Geoffrey Berry,J. N. S. Matthews
Publisher : John Wiley & Sons
Page : 832 pages
File Size : 49,8 Mb
Release : 2013-07-01
Category : Medical
ISBN : 9781118702581

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Statistical Methods in Medical Research by Peter Armitage,Geoffrey Berry,J. N. S. Matthews Pdf

The explanation and implementation of statistical methods for themedical researcher or statistician remains an integral part ofmodern medical research. This book explains the use of experimentaland analytical biostatistics systems. Its accessible style allowsit to be used by the non-mathematician as a fundamental componentof successful research. Since the third edition, there have been many developments instatistical techniques. The fourth edition provides the medicalstatistician with an accessible guide to these techniques and toreflect the extent of their usage in medical research. The new edition takes a much more comprehensive approach to itssubject. There has been a radical reorganization of the text toimprove the continuity and cohesion of the presentation and toextend the scope by covering many new ideas now being introducedinto the analysis of medical research data. The authors have triedto maintain the modest level of mathematical exposition thatcharacterized the earlier editions, essentially confining themathematics to the statement of algebraic formulae rather thanpursuing mathematical proofs. Received the Highly Commended Certificate in the PublicHealth Category of the 2002 BMA BooksCompetition.

Author : Karen M. Becker,John J. Whyte
Publisher : Springer Science & Business Media
Page : 360 pages
File Size : 45,9 Mb
Release : 2007-11-05
Category : Technology & Engineering
ISBN : 9781597450041

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Clinical Evaluation of Medical Devices by Karen M. Becker,John J. Whyte Pdf

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 device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Author : John C. Bailar III,Frederick Mosteller
Publisher : CRC Press
Page : 490 pages
File Size : 42,9 Mb
Release : 2019-05-20
Category : Mathematics
ISBN : 9780429529603

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Medical Uses of Statistics by John C. Bailar III,Frederick Mosteller Pdf

This work explains the purpose of statistical methods in medical studies and analyzes the statistical techniques used by clinical investigators, with special emphasis on studies published in "The New England Journal of Medicine". It clarifies fundamental concepts of statistical design and analysis, and facilitates the understanding of research results.

Author : Margaret Sullivan Pepe
Publisher : OUP Oxford
Page : 319 pages
File Size : 45,5 Mb
Release : 2003-03-13
Category : Medical
ISBN : 9780191588617

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The Statistical Evaluation of Medical Tests for Classification and Prediction by Margaret Sullivan Pepe Pdf

This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.

Author : Ram Tiwari,Jyoti Zalkikar,Lan Huang
Publisher : CRC Press
Page : 243 pages
File Size : 41,5 Mb
Release : 2021-06-24
Category : Medical
ISBN : 9780429521928

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Signal Detection for Medical Scientists by Ram Tiwari,Jyoti Zalkikar,Lan Huang Pdf

Signal Detection for Medical Scientists: Likelihood Ratio Based Test-Based Methodology presents the data mining techniques with focus on likelihood ratio test (LRT) based methods for signal detection. It emphasizes computational aspect of LRT methodology and is pertinent for first-time researchers and graduate students venturing into this interesting field. The book is written as a reference book for professionals in pharmaceutical industry, manufactures of medical devices, and regulatory agencies. The book deals with the signal detection in drug/device evaluation, which is important in the post-market evaluation of medical products, and in the pre-market signal detection during clinical trials for monitoring procedures. It should also appeal to academic researchers, and faculty members in mathematics, statistics, biostatistics, data science, pharmacology, engineering, epidemiology, and public health. Therefore, this book is well suited for both research and teaching. Key Features: Includes a balanced discussion of art of data structure, issues in signal detection, statistical methods and analytics, and implementation of the methods. Provides a comprehensive summary of the LRT methods for signal detection including the basic theory and extensions for varying datasets that may be large post-market data or pre-market clinical trial data. Contains details of scientific background, statistical methods, and associated algorithms that a reader can quickly master the materials and apply methods in the book on one’s own problems

Author : A. Lawrence Gould
Publisher : John Wiley & Sons
Page : 390 pages
File Size : 46,9 Mb
Release : 2015-02-23
Category : Medical
ISBN : 9781119979661

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Statistical Methods for Evaluating Safety in Medical Product Development by A. Lawrence Gould Pdf

This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Page : 528 pages
File Size : 55,8 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210413

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Medical Device Design for Six Sigma by Basem El-Haik,Khalid S. Mekki Pdf

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.