Ethical Issues In Drug Research PDF Download
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Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 432 |
Release | : 2012-10-13 |
Genre | : Medical |
ISBN | : 0309225493 |
Download Safe and Effective Medicines for Children Book in PDF, ePub and Kindle
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author | : Bernard Lo |
Publisher | : Lippincott Williams & Wilkins |
Total Pages | : 302 |
Release | : 2012-03-28 |
Genre | : Medical |
ISBN | : 1451152779 |
Download Ethical Issues in Clinical Research Book in PDF, ePub and Kindle
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.
Author | : Michael J. Parnham |
Publisher | : |
Total Pages | : 155 |
Release | : 1996-01-01 |
Genre | : Drugs |
ISBN | : 9784274901072 |
Download Ethical Issues in Drug Research Book in PDF, ePub and Kindle
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 445 |
Release | : 2004-07-09 |
Genre | : Medical |
ISBN | : 0309133386 |
Download Ethical Conduct of Clinical Research Involving Children Book in PDF, ePub and Kindle
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Author | : Gerd Hanekamp |
Publisher | : Springer |
Total Pages | : 0 |
Release | : 2010-11-25 |
Genre | : Philosophy |
ISBN | : 9783642091407 |
Download Business Ethics of Innovation Book in PDF, ePub and Kindle
Firms generally depend upon innovations in order to achieve advantages on competitive markets, thus also raising societal questions. Business ethics provides a normative framework for balancing the different perspectives, values, and interests at stake. This balance must be achieved both at relevant firm and regulatory levels. Business Ethics of Innovation is thus necessarily an interdisciplinary endeavour. This volume assesses general questions of how business ethics may contribute to adequate innovations and specifically discusses respective case studies in pharmaceutical and IT sectors.
Author | : Anna C. Mastroianni |
Publisher | : |
Total Pages | : 268 |
Release | : 1994 |
Genre | : Human experimentation in medicine |
ISBN | : |
Download Women and Health Research Book in PDF, ePub and Kindle
Author | : Jürgen Boomgaarden |
Publisher | : Berghahn Books |
Total Pages | : 152 |
Release | : 2003 |
Genre | : Law |
ISBN | : 9781571816016 |
Download Issues in Medical Research Ethics Book in PDF, ePub and Kindle
With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.
Author | : Michael A. Santoro |
Publisher | : Cambridge University Press |
Total Pages | : 528 |
Release | : 2005-10-31 |
Genre | : Business & Economics |
ISBN | : 1139448579 |
Download Ethics and the Pharmaceutical Industry Book in PDF, ePub and Kindle
Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 292 |
Release | : 2012-07-30 |
Genre | : Medical |
ISBN | : 0309218160 |
Download Ethical and Scientific Issues in Studying the Safety of Approved Drugs Book in PDF, ePub and Kindle
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 | : Jillian Cohen |
Publisher | : Pluto Press (UK) |
Total Pages | : 326 |
Release | : 2006-10-20 |
Genre | : Business & Economics |
ISBN | : |
Download The Power of Pills Book in PDF, ePub and Kindle
a ~This is a truly first rate text, and, indeed, required reading for all critical students of tort.a (TM) Student Law Review