Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment
Author: Jeffrey Gibbs
Publisher:
Published: 2020-12-20
Total Pages:
ISBN-13: 9781935065890
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Modern Methods of Clinical Investigation
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1990-02-01
Total Pages: 241
ISBN-13: 0309042860
DOWNLOAD EBOOKThe 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
Author: Adam Bohr
Publisher: Academic Press
Published: 2020-06-21
Total Pages: 385
ISBN-13: 0128184396
DOWNLOAD EBOOKArtificial 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
Traumatic Brain and Spinal Cord Injury
Author: Cristina Morganti-Kossmann
Publisher: Cambridge University Press
Published: 2012-07-19
Total Pages: 361
ISBN-13: 1107007437
DOWNLOAD EBOOKPresents the most up-to-date clinical and experimental research in neurotrauma in an illustrated, accessible, comprehensive volume.
The Changing Economics of Medical Technology
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1991-02-01
Total Pages: 225
ISBN-13: 030904491X
DOWNLOAD EBOOKAmericans 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
Author: Raymond A. Huml
Publisher: Springer Nature
Published: 2021-11-08
Total Pages: 418
ISBN-13: 3030786056
DOWNLOAD EBOOKThis 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.
Cancer Nanotechnology
Author:
Publisher: Academic Press
Published: 2018-06-23
Total Pages: 224
ISBN-13: 0128141700
DOWNLOAD EBOOKAdvances 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
Implementing CDISC Using SAS
Author: Chris Holland
Publisher: SAS Institute
Published: 2019-05-30
Total Pages: 294
ISBN-13: 1642952419
DOWNLOAD EBOOKFor 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.
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
Author: Michael J. Klepper
Publisher: Jones & Bartlett Publishers
Published: 2010-09-15
Total Pages: 332
ISBN-13: 1449671551
DOWNLOAD EBOOKDrug 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
Author: Scott L Greer
Publisher: University of Michigan Press
Published: 2021-04-19
Total Pages: 416
ISBN-13: 0472902466
DOWNLOAD EBOOKCOVID-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.
