Diagnostics At A Crossroads Navigating Ivd Regulation In A Changing Environment PDF Download
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Author | : Jeffrey Gibbs |
Publisher | : |
Total Pages | : |
Release | : 2020-12-20 |
Genre | : |
ISBN | : 9781935065890 |
Download Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment Book in PDF, ePub and Kindle
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 241 |
Release | : 1990-02-01 |
Genre | : Medical |
ISBN | : 0309042860 |
Download Modern Methods of Clinical Investigation Book in PDF, ePub and Kindle
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author | : Per-Anders Mårdh |
Publisher | : Coronet Books |
Total Pages | : 232 |
Release | : 1986 |
Genre | : Coagulase |
ISBN | : |
Download Coagulase-negative Staphylococci Book in PDF, ePub and Kindle
Author | : Adam Bohr |
Publisher | : Academic Press |
Total Pages | : 385 |
Release | : 2020-06-21 |
Genre | : Computers |
ISBN | : 0128184396 |
Download Artificial Intelligence in Healthcare Book in PDF, ePub and Kindle
Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. Highlights different data techniques in healthcare data analysis, including machine learning and data mining Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks Includes applications and case studies across all areas of AI in healthcare data
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 225 |
Release | : 1991-02-01 |
Genre | : Medical |
ISBN | : 030904491X |
Download The Changing Economics of Medical Technology Book in PDF, ePub and Kindle
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author | : Raymond A. Huml |
Publisher | : Springer Nature |
Total Pages | : 418 |
Release | : 2021-11-08 |
Genre | : Medical |
ISBN | : 3030786056 |
Download Rare Disease Drug Development Book in PDF, ePub and Kindle
This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.
Author | : Cristina Morganti-Kossmann |
Publisher | : Cambridge University Press |
Total Pages | : 361 |
Release | : 2012-07-19 |
Genre | : Medical |
ISBN | : 1107007437 |
Download Traumatic Brain and Spinal Cord Injury Book in PDF, ePub and Kindle
Presents the most up-to-date clinical and experimental research in neurotrauma in an illustrated, accessible, comprehensive volume.
Author | : Liron Pantanowitz |
Publisher | : |
Total Pages | : 304 |
Release | : 2017 |
Genre | : Medical informatics |
ISBN | : 9780891896104 |
Download Digital Pathology Book in PDF, ePub and Kindle
The definitive, complete reference of digital pathology! An extraordinarily comprehensive and complete book for individuals with anything from minimal knowledge to deep, accomplished experience in digital pathology. Easy to read and plainly written, Digital Pathology examines the history and technological evolution of digital pathology, from the birth of scanning technology and telepathology to three-dimensional imaging on large multi-touch displays and computer aided diagnosis. A must-have book for anyone wishing to learn more about and work in this exciting and critical information environment including pathologists, laboratory professionals, students and any other medical practitioners with a particular interest in the history and future of digital pathology. It can also be a useful reference for anyone, medical or non-medical, who have an interest in learning more about the field. Digital pathology is truly a game changer, and this book is a crucial tool for anyone wishing to know more. Subjects discussed in depth include: Static digital imaging; basics and clinical use. Digital imaging processes. Telepathology. While slide imaging. Clinical applications of whole slide imaging. Digital pathology for educational, quality improvement, research and other settings. Forensic digital imaging.
Author | : Michael J. Klepper |
Publisher | : Jones & Bartlett Learning |
Total Pages | : 332 |
Release | : 2011 |
Genre | : Medical |
ISBN | : 0763769126 |
Download Drug Safety Data Book in PDF, ePub and Kindle
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides pharmaceutical scientists, researchers and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, discuss how quality planning, safety training and data standardization result in significant cost, time and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides the definitive guide to drug safety data analysis and reporting. Key features include: Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports Pragmatic tipsàand mistakes to avoid Simple explanations of what safety data are collected, and what the data mean Practical approaches to determining a drug effect and understanding its clinical significance Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical Examples of user-friendly data displays that enhance safety signal identification Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting Relevant material for the required training of drug safety/pharmacovigilance professionals SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Author | : Chris Holland |
Publisher | : SAS Institute |
Total Pages | : 294 |
Release | : 2019-05-30 |
Genre | : Computers |
ISBN | : 1642952419 |
Download Implementing CDISC Using SAS Book in PDF, ePub and Kindle
For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.