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Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 178 pages
Book Rating : 4.M/5 ( download)
Download or read book FDA Clinical Experience Abstracts written by United States. Food and Drug Administration and published by . This book was released on 1967 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Author : United States. Food and Drug Administration. Medical Library
Publisher :
ISBN 13 :
Total Pages : 176 pages
Book Rating : 4.3/5 (91 download)
Download or read book FDA Medical Library Serials Holdings List written by United States. Food and Drug Administration. Medical Library and published by . This book was released on 1998 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 1254 pages
Book Rating : 4.3/5 (121 download)
Download or read book Federal Register written by and published by . This book was released on 1972-08 with total page 1254 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Publisher :
ISBN 13 :
Total Pages : 386 pages
Book Rating : 4.:/5 (327 download)
Download or read book Use of Advisory Committees by the Food and Drug Administration written by United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee and published by . This book was released on 1975 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Eunjoo Pacifici
Publisher : Academic Press
ISBN 13 : 0128111569
Total Pages : 280 pages
Book Rating : 4.1/5 (281 download)
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Author : S. Lori Brown
Publisher : John Wiley & Sons
ISBN 13 : 9780470060865
Total Pages : 528 pages
Book Rating : 4.0/5 (68 download)
Download or read book Medical Device Epidemiology and Surveillance written by S. Lori Brown and published by John Wiley & Sons. This book was released on 2007-03-13 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.
Author : United States. Department of Health and Human Services
Publisher :
ISBN 13 :
Total Pages : 596 pages
Book Rating : 4.F/5 ( download)
Download or read book Publication Catalog of the U.S. Department of Health and Human Services written by United States. Department of Health and Human Services and published by . This book was released on with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Department of Health, Education, and Welfare
Publisher :
ISBN 13 :
Total Pages : 700 pages
Book Rating : 4.:/5 (319 download)
Download or read book Publication Catalog of the U.S. Department of Health, Education, and Welfare written by United States. Department of Health, Education, and Welfare and published by . This book was released on 1977 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Dept. of Health, Education, and Welfare
Publisher :
ISBN 13 :
Total Pages : 696 pages
Book Rating : 4.3/5 (91 download)
Download or read book Publication Catalog of the U. S. Department of Health, Education and Welfare written by United States. Dept. of Health, Education, and Welfare and published by . This book was released on 1978 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt:
![Download Catalog [of] Publications PDF Online Free](https://books.google.com/books/content/images/frontcover/Qv5PAQAAIAAJ?fife=w200-h370)
Author : United States. Department of Health, Education, and Welfare
Publisher :
ISBN 13 :
Total Pages : 710 pages
Book Rating : 4.:/5 ( download)
Download or read book Catalog [of] Publications written by United States. Department of Health, Education, and Welfare and published by . This book was released on 1976 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Department of Health, Education, and Welfare. Media and Publication Management Information Staff
Publisher :
ISBN 13 :
Total Pages : 696 pages
Book Rating : 4.F/5 ( download)
Download or read book Publication Catalog of the U.S. Department of Health, Education, and Welfare written by United States. Department of Health, Education, and Welfare. Media and Publication Management Information Staff and published by . This book was released on with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309218160
Total Pages : 292 pages
Book Rating : 4.3/5 (92 download)
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Library of Medicine (U.S.)
Publisher :
ISBN 13 :
Total Pages : 944 pages
Book Rating : 4.:/5 (319 download)
Download or read book National Library of Medicine Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1965 with total page 944 pages. Available in PDF, EPUB and Kindle. Book excerpt:
