Download or read book Diagnostics at a Crossroads Navigating IVD Regulation in a Changing Environment written by Jeffrey Gibbs and published by . This book was released on 2020-12-20 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Coagulase negative Staphylococci written by Per-Anders Mårdh and published by Coronet Books. This book was released on 1986 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Artificial Intelligence in Healthcare written by Adam Bohr and published by Academic Press. This book was released on 2020-06-21 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Rare Disease Drug Development written by Raymond A. Huml and published by Springer Nature. This book was released on 2021-11-08 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Traumatic Brain and Spinal Cord Injury written by Cristina Morganti-Kossmann and published by Cambridge University Press. This book was released on 2012-07-19 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the most up-to-date clinical and experimental research in neurotrauma in an illustrated, accessible, comprehensive volume.

Download or read book Digital Pathology written by Liron Pantanowitz and published by . This book was released on 2017 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Implementing CDISC Using SAS written by Chris Holland and published by SAS Institute. This book was released on 2019-05-30 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2011 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

Download or read book Cancer Nanotechnology written by and published by Academic Press. This book was released on 2018-06-23 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in Cancer Research, Volume 139, provides invaluable information on the exciting and fast-moving field of cancer research. Original reviews are presented on a variety of topics relating to the rapidly developing intersection between nanotechnology and cancer research, with unique sections in the new release focusing on Exosomes as a theranostic for lung cancer, Nanotechnology and cancer immunotherapy, Ultrasound imaging agents and delivery systems, Dendronized systems for the delivery of chemotherapeutics, Thermosensitive liposomes for image-guided drug delivery, Supramolecular Chemistry in Tumor Analysis and Drug Delivery, Gold nanoparticles for delivery of cancer therapeutics, and Single cell barcode microchip for cancer research and therapy. Provides the latest information on cancer research Offers outstanding and original reviews on a range of cancer research topics Serves as an indispensable reference for researchers and students alike

Download or read book A Practical Guide to FDA s Food and Drug Law and Regulation Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Download or read book Coronavirus Politics written by Scott L Greer and published by University of Michigan Press. This book was released on 2021-04-19 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: COVID-19 is the most significant global crisis of any of our lifetimes. The numbers have been stupefying, whether of infection and mortality, the scale of public health measures, or the economic consequences of shutdown. Coronavirus Politics identifies key threads in the global comparative discussion that continue to shed light on COVID-19 and shape debates about what it means for scholarship in health and comparative politics. Editors Scott L. Greer, Elizabeth J. King, Elize Massard da Fonseca, and André Peralta-Santos bring together over 30 authors versed in politics and the health issues in order to understand the health policy decisions, the public health interventions, the social policy decisions, their interactions, and the reasons. The book’s coverage is global, with a wide range of key and exemplary countries, and contains a mixture of comparative, thematic, and templated country studies. All go beyond reporting and monitoring to develop explanations that draw on the authors' expertise while engaging in structured conversations across the book.

Download or read book The Arc of Crisis in the MENA Region written by Karim Mezran and published by Ledizioni. This book was released on 2018-10-02 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Arc of Crisis in the MENA Region volume deals with the countries of the Middle East and North Africa that are facing a particularly troubled period in their historical development. Syria, Iraq, Libya, Egypt and to a lesser extent Jordan and Tunisia have plunged into a legitimacy crisis that in some cases has turned into civil war or violent upheaval. As traditional authorities lose their legitimacy, two alternatives are emerging. The first is a more decentralized system of government, evinced by the empowerment of subnational government bodies and the growing legitimacy of local authorities; in this trend, the local authorities are able to keep the state united and more functional. The second is a growing number of political groups that act as opposition to authoritarianism, which is experiencing a revival. The analysis herein also focuses on Islamist movements; namely, their organizational and ideological development as well as how the shrinking of the political space affects them and the entire polity. This Report explores the distinctive dynamics and characteristics of these challenges in the post-Arab Spring era.

Download or read book Mass Spectrometry An Issue of Clinics in Laboratory Medicine E Book written by Nigel Clarke and published by Elsevier Health Sciences. This book was released on 2011-10-03 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: This issue of Clinics in Laboratory Medicine, Guest Edited by Nigel Clarke, MD, and Andrew Hoofnagle, MD, will focus on Mass Spectrometry, with topics including: Proteins; Peptides; Small Molecules: Toxicology; Small Molecules: Diagnostics; and Regulatory Considerations.

Download or read book Biotech Innovations and Fundamental Rights written by Roberto Bin and published by Springer Science & Business Media. This book was released on 2012-05-13 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology is a recognized research area that has increasingly advanced into new technologies and modern practices raising several legal, ethical and regulatory issues. The revolutionary speed of biotech innovations has had a significant impact on the protection of the rights of the individual. Fundamental rights provide a framework within which the justification of limitations and restrictions to biotechnology innovations and research results have to be assessed. The legal regulation of scientific research and scientific investigations impact more and more directly on the freedom of research and therapies as well as on the broad diffusion of knowledge. Closely related is also the debated question of the technological manipulation of life and the boundary of scientific knowledge with regard to the topical question of genetic invention patents and their side effects on access to scientific information and health care opportunities. Drawing on expertise from different disciplines, the volume comprises invited papers and plenary presentations given at the conference entitled “Biotech Innovations & Fundamental Rights” that took place on Januray 20-21 2011 at the Department of Juridical Sciences of the University of Ferrara. Each contribution covers a different aspect of the legal and scientific issues involved in regulation of biotechnology. In particular the focus of attention has been given to genetic research, genetic data, freedom of scientific research in genetics and biotech patents.

Download or read book Digital Health written by Homero Rivas and published by Springer. This book was released on 2018-01-02 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a comprehensive state-of the-art approach to digital health technologies and practices within the broad confines of healthcare practices. It provides a canvas to discuss emerging digital health solutions, propelled by the ubiquitous availability of miniaturized, personalized devices and affordable, easy to use wearable sensors, and innovative technologies like 3D printing, virtual and augmented reality and driverless robots and vehicles including drones. One of the most significant promises the digital health solutions hold is to keep us healthier for longer, even with limited resources, while truly scaling the delivery of healthcare. Digital Health: Scaling Healthcare to the World addresses the emerging trends and enabling technologies contributing to technological advances in healthcare practice in the 21st Century. These areas include generic topics such as mobile health and telemedicine, as well as specific concepts such as social media for health, wearables and quantified-self trends. Also covered are the psychological models leveraged in design of solutions to persuade us to follow some recommended actions, then the design and educational facets of the proposed innovations, as well as ethics, privacy, security, and liability aspects influencing its acceptance. Furthermore, sections on economic aspects of the proposed innovations are included, analyzing the potential business models and entrepreneurship opportunities in the domain.