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Author : Masatsugu Tsuji
Publisher :
ISBN 13 :
Total Pages : 34 pages
Book Rating : 4.:/5 ( download)
Download or read book The Application of CVM for Assessing Medical Technology written by Masatsugu Tsuji and published by . This book was released on 2001 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309038294
Total Pages : 709 pages
Book Rating : 4.3/5 (9 download)
Download or read book Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Author :
Publisher :
ISBN 13 :
Total Pages : 36 pages
Book Rating : 4.:/5 (42 download)
Download or read book Strategies for Medical Technology Assessment written by and published by . This book was released on 1982 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Congress. Office of Technology Assessment
Publisher :
ISBN 13 :
Total Pages : 152 pages
Book Rating : 4.3/5 (91 download)
Download or read book Assessing the Efficacy and Safety of Medical Technologies written by United States. Congress. Office of Technology Assessment and published by . This book was released on 1978 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Karen M. Becker
Publisher : Springer Science & Business Media
ISBN 13 : 1597450049
Total Pages : 342 pages
Book Rating : 4.5/5 (974 download)
Download or read book Clinical Evaluation of Medical Devices written by Karen M. Becker and published by Springer Science & Business Media. This book was released on 2007-11-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Institute of Medicine (U.S.). Division of Health Sciences Policy
Publisher :
ISBN 13 :
Total Pages : 573 pages
Book Rating : 4.:/5 (13 download)
Download or read book Assessing Medical Technologies written by Institute of Medicine (U.S.). Division of Health Sciences Policy and published by . This book was released on 1985 with total page 573 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joshi
Publisher : Jones & Bartlett Learning
ISBN 13 : 128410396X
Total Pages : 441 pages
Book Rating : 4.2/5 (841 download)
Download or read book Population Health Informatics written by Joshi and published by Jones & Bartlett Learning. This book was released on 2017-09-26 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Population Health Informatics addresses the growing opportunity to utilize technology to put into practice evidence-based solutions to improve population health outcomes across diverse settings. The book focuses on how to operationalize population informatics solutions to address important public health challenges impacting individuals, families, communities, and the environment in which they live. The book uniquely uses a practical, step-by-step approach to implement evidence-based, data- driven population informatics solutions.
Author : Charalambos D. Aliprantis
Publisher : Springer Science & Business Media
ISBN 13 : 3662058588
Total Pages : 733 pages
Book Rating : 4.6/5 (62 download)
Download or read book Assets, Beliefs, and Equilibria in Economic Dynamics written by Charalambos D. Aliprantis and published by Springer Science & Business Media. This book was released on 2013-11-11 with total page 733 pages. Available in PDF, EPUB and Kindle. Book excerpt: A collection of papers dealing with a broad range of topics in mathematical economics, game theory and economic dynamics. The contributions present both theoretical and applied research. The volume is dedicated to Mordecai Kurz. The papers were presented in a special symposium co-hosted by the Stanford University Department of Economics and by the Stanford Institute of Economic Policy Research in August 2002.
Author : David A. Wise
Publisher : University of Chicago Press
ISBN 13 : 0226903249
Total Pages : 273 pages
Book Rating : 4.2/5 (269 download)
Download or read book Health Care Issues in the United States and Japan written by David A. Wise and published by University of Chicago Press. This book was released on 2007-12-01 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent data show wide disparity between Japan and the United States in the effectiveness of their health care systems. Japan spends close to the lowest percentage of its gross domestic product on health care among OECD countries, the United States spends the highest, yet life expectancies in Japan are among the world’s longest. Clearly, a great deal can be learned from a comprehensive comparative analysis of health care issues in these two countries. In Health Care Issues in the United States and Japan, contributors explore the structural characteristics of the health care systems in both nations, the economic incentives underlying the systems, and how they operate in practice. Japan’s system, they show, is characterized by generous insurance schemes, a lack of gatekeepers, and fee-for-service mechanisms. The United States’ structure, on the other hand, is distinguished by for-profit hospitals, privatized health insurance, and managed care. But despite its relative success, an aging population and a general shift from infectious diseases to more chronic maladies are forcing the Japanese to consider a model more closely resembling that of the United States. In an age when rising health care costs and aging populations are motivating reforms throughout the world, this timely study will prove invaluable.
Author : Carmen Medina
Publisher : CRC Press
ISBN 13 : 0824740785
Total Pages : 604 pages
Book Rating : 4.8/5 (247 download)
Download or read book Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics written by Carmen Medina and published by CRC Press. This book was released on 2003-12-09 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Author : John M. Centanni
Publisher : CRC Press
ISBN 13 : 1498758851
Total Pages : 357 pages
Book Rating : 4.4/5 (987 download)
Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2016-09-19 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.
Author : Shayne C. Gad
Publisher : Springer Nature
ISBN 13 : 3030352412
Total Pages : 490 pages
Book Rating : 4.0/5 (33 download)
Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 1441974490
Total Pages : 135 pages
Book Rating : 4.4/5 (419 download)
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Author : IBP, Inc.
Publisher : Lulu.com
ISBN 13 : 1577515609
Total Pages : 316 pages
Book Rating : 4.5/5 (775 download)
Download or read book US Medical Drugs Development, Approval Process and Regulations Handbook Volume 1 Strategic, Practical Information and Regulations written by IBP, Inc. and published by Lulu.com. This book was released on 2016-03-05 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: US Medical Drugs Development, Approval Process and Regulations Handbook Volume 1 Strategic, Practical Information and Regulations
Author : United States. Congress. House. Committee on Agriculture. Subcommittee on Livestock, Dairy, and Poultry
Publisher :
ISBN 13 :
Total Pages : 520 pages
Book Rating : 4.3/5 (121 download)
Download or read book Provide for a Research Program to Examine and Enhance Agricultural Production and Food Processing Systems written by United States. Congress. House. Committee on Agriculture. Subcommittee on Livestock, Dairy, and Poultry and published by . This book was released on 1988 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 0429576838
Total Pages : 1125 pages
Book Rating : 4.4/5 (295 download)
Download or read book Parenteral Medications, Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Author : Shayne C. Gad
Publisher : CRC Press
ISBN 13 : 9781439876084
Total Pages : 576 pages
Book Rating : 4.8/5 (76 download)
Download or read book Safety Evaluation of Medical Devices written by Shayne C. Gad and published by CRC Press. This book was released on 2001-12-04 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.
