Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment

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Publisher :
ISBN 13 : 9781935065890
Total Pages : pages
Book Rating : 4.0/5 (658 download)

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Book Synopsis Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment by : Jeffrey Gibbs

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:

Modern Methods of Clinical Investigation

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Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

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.

Artificial Intelligence in Healthcare

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Publisher : Academic Press
ISBN 13 : 0128184396
Total Pages : 385 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Artificial Intelligence in Healthcare by : Adam Bohr

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

The Changing Economics of Medical Technology

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Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine

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.

Rare Disease Drug Development

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Publisher : Springer Nature
ISBN 13 : 3030786056
Total Pages : 418 pages
Book Rating : 4.0/5 (37 download)

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Book Synopsis Rare Disease Drug Development by : Raymond A. Huml

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.

Traumatic Brain and Spinal Cord Injury

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Publisher : Cambridge University Press
ISBN 13 : 1107007437
Total Pages : 361 pages
Book Rating : 4.1/5 (7 download)

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Book Synopsis Traumatic Brain and Spinal Cord Injury by : Cristina Morganti-Kossmann

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.

Implementing CDISC Using SAS

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Publisher : SAS Institute
ISBN 13 : 1642952419
Total Pages : 294 pages
Book Rating : 4.6/5 (429 download)

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Book Synopsis Implementing CDISC Using SAS by : Chris Holland

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.

Cancer Nanotechnology

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Publisher : Academic Press
ISBN 13 : 0128141700
Total Pages : 224 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Cancer Nanotechnology by :

Download or read book Cancer Nanotechnology written by and published by Academic Press. This book was released on 2018-06-23 with total page 224 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

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

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Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449671551
Total Pages : 332 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk by : Michael J. Klepper

Download or read book Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 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 was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, 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 pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert 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 is 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 tips...and 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)

Coronavirus Politics

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Publisher : University of Michigan Press
ISBN 13 : 0472902466
Total Pages : 416 pages
Book Rating : 4.4/5 (729 download)

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Book Synopsis Coronavirus Politics by : Scott L Greer

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.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

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Publisher :
ISBN 13 : 9781935065876
Total Pages : 672 pages
Book Rating : 4.0/5 (658 download)

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Book Synopsis A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition by : Stephen M. Kanovsky

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.

The Arc of Crisis in the MENA Region

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Publisher : Ledizioni
ISBN 13 : 8867058584
Total Pages : 195 pages
Book Rating : 4.8/5 (67 download)

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Book Synopsis The Arc of Crisis in the MENA Region by : Karim Mezran

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 195 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.

Mass Spectrometry, An Issue of Clinics in Laboratory Medicine

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Publisher : Elsevier Health Sciences
ISBN 13 : 1455712019
Total Pages : 104 pages
Book Rating : 4.4/5 (557 download)

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Book Synopsis Mass Spectrometry, An Issue of Clinics in Laboratory Medicine by : Nigel Clarke

Download or read book Mass Spectrometry, An Issue of Clinics in Laboratory Medicine written by Nigel Clarke and published by Elsevier Health Sciences. This book was released on 2011-12-28 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.

Biotech Innovations and Fundamental Rights

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Publisher : Springer Science & Business Media
ISBN 13 : 8847020328
Total Pages : 346 pages
Book Rating : 4.8/5 (47 download)

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Book Synopsis Biotech Innovations and Fundamental Rights by : Roberto Bin

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.

Digital Health

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Publisher : Springer
ISBN 13 : 3319614460
Total Pages : 372 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Digital Health by : Homero Rivas

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.

Pathology Informatics: Theory and Practice

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Publisher : American Society of Clinical Pathologists Press
ISBN 13 : 9780891895831
Total Pages : 352 pages
Book Rating : 4.8/5 (958 download)

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Book Synopsis Pathology Informatics: Theory and Practice by : Liron Pantanowitz

Download or read book Pathology Informatics: Theory and Practice written by Liron Pantanowitz and published by American Society of Clinical Pathologists Press. This book was released on 2012 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pathology Informatics: Theory & Practice is the first multi- authored, current and comprehensive compendium of the diverse and rapidly expanding field of pathology informatics. It includes all of the critical and practical advice for management, operations, budgeting, and project planning and will serve as a comprehensive review of the field for students, pathologists, and laboratory professionals. This book deals with the role of computing hardware, software and databases involved in the efficient information management for pathology practice, as well as the fundamental science of informatics that is so deeply embedded in this subspecialty. The text builds from basic principles of computer theory to more sophisticated informatics concepts. Databases and data mining; networks and workstations; system interfaces and interoperability. Bioinformatics, imaging informatics, clinical informatics, and public health informatics. Automation and middleware that facilitate complex workflows encountered in both anatomic and clinical pathology practice. Molecular testing and point of care solutions. Coding and nomenclature. Standards in Laboratory Information Systems (LIS) and imaging systems. Project management and business skills. Pathology reporting. Electronic medical records. Specimen tracking and identification. Error reduction and quality management. Training and education in pathology informatics.

Hazard Mitigation Grant Program Desk Reference (FEMA 345)

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Publisher : Createspace Independent Pub
ISBN 13 : 9781482339888
Total Pages : 236 pages
Book Rating : 4.3/5 (398 download)

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Book Synopsis Hazard Mitigation Grant Program Desk Reference (FEMA 345) by : Federal Emergency Management Agency

Download or read book Hazard Mitigation Grant Program Desk Reference (FEMA 345) written by Federal Emergency Management Agency and published by Createspace Independent Pub. This book was released on 2013-02-01 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: FEMA's Hazard Mitigation Grant Program is a powerful resource in the combined effort by Federal, State, and local government, as well as private industry and homeowners, to end the cycle of repetitive disaster damage. The Robert T. Stafford Disaster Relief and Emergency Assistance Act was passed on November 23, 1988, amending Public Law 93-288, the Disaster Relief Act of 1974. The Stafford Act included Section 404, which established the Hazard Mitigation Grant Program. In 1993, the Hazard Mitigation and Relocation Act amended Section 404 to increase the amount of HMGP funds available and the cost-share to 75 percent Federal. This amendment also encouraged the use of property acquisition and other non-structural flood mitigation measures. In an effort to streamline HMGP delivery, FEMA encourages States to develop their mitigation programs before disaster strikes. States are adopting a more active HMGP management role. Increased capabilities may include: Conducting comprehensive all-hazard mitigation planning prior to disaster events; Providing applicants technical assistance on sound mitigation techniques and hazard mitigation policy and procedures; Coordinating mitigation programs through interagency teams or councils. Conducting benefit-cost analyses; and Preparing National Environmental Policy Act reviews for FEMA approval. States that integrate the HMGP with their frequently updated State Administrative and Hazard Mitigation Plans will create cohesive and effective approaches to loss reduction. This type of coordinated approach minimizes the distinction between “predisaster” and “post-disaster” time periods, and instead produces an ongoing mitigation effort. Hazard mitigation is any sustained action taken to reduce or eliminate long-term risk to people and property from natural hazards and their effects. A key purpose of the HMGP is to ensure that the opportunity to take critical mitigation measures to protect life and property from future disasters is not lost during the recovery and reconstruction process following a disaster. Program grant funds available under Section 404 of the Stafford Act provide States with the incentive and capability to implement mitigation measures that previously may have been infeasible. The purpose of this Desk Reference is to: Provide comprehensive information about FEMA's Hazard Mitigation Grant Program (HMGP); Increase awareness of the HMGP as an integral part of statewide hazard mitigation efforts; and Encourage deeper commitments and increased responsibilities on the part of all States and communities to reduce damage and losses from natural disasters. This Desk Reference is organized to simplify program information and assist the reader with practical guidance for successful participation in the program. Lists of program-related acronyms and definitions are included, along with appendices that amplify selected aspects of the HMGP. This Desk Reference is organized into 14 sections, each of which presents a major HMGP subject area. In each section, information is presented on the right side of the page. In several sections, job aids containing supplemental material are provided. The job aids for each section can be found at the end of the section. At the front of each section, there is a detailed table of contents to help you locate specific information.