Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials
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Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials
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Author : CreateSpace Independent Publishing Platform
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2018-07-03
Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials written by CreateSpace Independent Publishing Platform and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-07-03 with categories.
Challenges to FDA's ability to monitor and inspect foreign clinical trials
Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials
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Author : United States. Department of Health and Human Services. Office of Inspector General
language : en
Publisher:
Release Date : 2010
Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials written by United States. Department of Health and Human Services. Office of Inspector General and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Biologicals categories.
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1999-07-27
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-07-27 with Medical categories.
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-07-30
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-30 with Medical categories.
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.
Integrity Of Scientific Research
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Author : Joel Faintuch
language : en
Publisher: Springer Nature
Release Date : 2022-10-13
Integrity Of Scientific Research written by Joel Faintuch and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-10-13 with Medical categories.
This book provides a scientific and ethical approach to all forms of fraud and misconduct focusing on a scholarly however practice-oriented description of the problems, roots and potential solutions. Organized in dedicated parts, an international team of experts systematically analyzes the most prevalent forms of misconduct, ghost writing, pseudo-science, dubious trials, predatory journals, fake news, mistreatment and harassment, in research, publications, at academic institutions, and in the professional and healthcare environment. A special focus is given to corrective interventions and the role of prevention, education and training. Comprehensive in its scope, the book offers an easy-to-read overview along with a number of real cases for experienced and novice personnel alike. The significance of scientific integrity and research ethics increased during the last couple of years and ethic committees and offices have become an integral part at universities, hospitals, research institutions, government agencies and major private organizations all over the world. Thus, this book provides an indispensable, comprehensive overview across disciplines and for everybody working in research and affiliated institutions. Chapter 37 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.
Phytochemicals As Lead Compounds For New Drug Discovery
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Author : Chukwuebuka Egbuna
language : en
Publisher: Elsevier
Release Date : 2019-09-07
Phytochemicals As Lead Compounds For New Drug Discovery written by Chukwuebuka Egbuna and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-07 with Science categories.
Phytochemicals as Lead Compounds for New Drug Discovery presents complete coverage of the recent advances in the discovery of phytochemicals from medicinal plants as models to the development of new drugs and chemical entities. Functional bioactive compounds of plant origin have been an invaluable source for many human therapeutic drugs and have played a major role in the treatment of diseases around the world. These compounds possess enormous structural and chemical diversity and have led to many important discoveries. This book presents fundament concepts and factors affecting the choice for plant-based products, as well as recent advances in computer-aided drug discovery and FDA drug candidacy acceptance criteria. It also details the various bioactive lead compounds and molecular targets for a range of life-threatening diseases including cancer, diabetes, and neurodegenerative diseases. Written by a global team of experts, Phytochemicals as Lead Compounds for New Drug Discovery is an ideal resource for drug developers, phytochemists, plant biochemists, food and medicinal chemists, nutritionists and toxicologists, chemical ecologists, taxonomists, analytical chemists, and other researchers in those fields. It will also be very valuable to professors, students, and researchers in this domain. Presents fundamental concepts and factors affecting choice for plant-based products Details the FDA drug candidacy acceptance criteria, including bottlenecks and way forward Highlights recent advances in computational-based drug discovery Focuses on the discovery of new drugs and potential druggable targets for the treatment of chronic diseases of world importance
The Oxford Handbook Of Prosocial Behavior
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Author : David A. Schroeder
language : en
Publisher: Oxford Library of Psychology
Release Date : 2015
The Oxford Handbook Of Prosocial Behavior written by David A. Schroeder and has been published by Oxford Library of Psychology this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Psychology categories.
"The Oxford Handbook of Prosocial Behavior provides a comprehensive review of the current literature contributing to our understanding of when and why people act to benefit others. The field of prosocial behavior encompasses a broad spectrum of activities, ranging from dyadic helping in emergencies, planned helping, volunteerism, and cooperation within and between groups. Taking a multi-level approach, the chapters explore the basic underlying evolutionary, developmental, emotional, cognitive, personality, and social psychological processes that set the stage for and motivate prosocial actions. Consideration is also given to applications to such real-world situations as the encouragement of pro-environmental behavior, the recruitment of participants for medical clinical trials, and the reduction of ethnic conflict and promotion of world peace"--Publisher.
Improving Usability Safety And Patient Outcomes With Health Information Technology
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Author : F. Lau
language : en
Publisher: IOS Press
Release Date : 2019-03-26
Improving Usability Safety And Patient Outcomes With Health Information Technology written by F. Lau and has been published by IOS Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-26 with Medical categories.
Information technology is revolutionizing healthcare, and the uptake of health information technologies is rising, but scientific research and industrial and governmental support will be needed if these technologies are to be implemented effectively to build capacity at regional, national and global levels. This book, "Improving Usability, Safety and Patient Outcomes with Health Information Technology", presents papers from the Information Technology and Communications in Health conference, ITCH 2019, held in Victoria, Canada from 14 to 17 February 2019. The conference takes a multi-perspective view of what is needed to move technology forward to sustained and widespread use by transitioning research findings and approaches into practice. Topics range from improvements in usability and training and the need for new and improved designs for information systems, user interfaces and interoperable solutions, to governmental policy, mandates, initiatives and the need for regulation. The knowledge and insights gained from the ITCH 2019 conference will surely stimulate fruitful discussions and collaboration to bridge research and practice and improve usability, safety and patient outcomes, and the book will be of interest to all those associated with the development, implementation and delivery of health IT solutions.
Mccarthy S Introduction To Health Care Delivery A Primer For Pharmacists
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Author : Kenneth W. Schafermeyer
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2016-09
Mccarthy S Introduction To Health Care Delivery A Primer For Pharmacists written by Kenneth W. Schafermeyer and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09 with Medical categories.
Introduction to Health Care Delivery: A Primer for Pharmacists, Sixth Edition provides students with a current and comprehensive overview of the U.S. health care delivery system from the perspective of the pharmacy profession. Each thoroughly updated chapter of this best-selling text includes real-world case studies, learning objectives, chapter review questions, questions for further discussion, and updated key topics and terms. Patient-Provider dialogues are also included to help students apply key concepts. Introduction to Health Care Delivery: A Primer for Pharmacists, Sixth Edition will provide students with an understanding of the social, organizational, and economic aspects of health care delivery.
Clinical Trials In Latin America Where Ethics And Business Clash
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Author : Nuria Homedes
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-29
Clinical Trials In Latin America Where Ethics And Business Clash written by Nuria Homedes and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-29 with Medical categories.
The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.