Safe and Effective Medicines for Children

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Author :
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethical Conduct of Clinical Research Involving Children

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Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Business Ethics of Innovation

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Publisher : Springer
ISBN 13 : 9783642091407
Total Pages : 0 pages
Book Rating : 4.0/5 (914 download)

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Book Synopsis Business Ethics of Innovation by : Gerd Hanekamp

Download or read book Business Ethics of Innovation written by Gerd Hanekamp and published by Springer. This book was released on 2010-11-25 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Women and Health Research

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Publisher :
ISBN 13 :
Total Pages : 268 pages
Book Rating : 4.3/5 (97 download)

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Book Synopsis Women and Health Research by : Anna C. Mastroianni

Download or read book Women and Health Research written by Anna C. Mastroianni and published by . This book was released on 1994 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Rational Therapeutics for Infants and Children

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Publisher : National Academies Press
ISBN 13 : 0309183642
Total Pages : 135 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rational Therapeutics for Infants and Children by : Institute of Medicine

Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Ethical Issues in Clinical Research

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Publisher : Lippincott Williams & Wilkins
ISBN 13 : 1451152779
Total Pages : 302 pages
Book Rating : 4.4/5 (511 download)

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Book Synopsis Ethical Issues in Clinical Research by : Bernard Lo

Download or read book Ethical Issues in Clinical Research written by Bernard Lo and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethics and the Pharmaceutical Industry

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Publisher : Cambridge University Press
ISBN 13 : 1139448579
Total Pages : 528 pages
Book Rating : 4.1/5 (394 download)

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Book Synopsis Ethics and the Pharmaceutical Industry by : Michael A. Santoro

Download or read book Ethics and the Pharmaceutical Industry written by Michael A. Santoro and published by Cambridge University Press. This book was released on 2005-10-31 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Issues in Medical Research Ethics

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Publisher : Berghahn Books
ISBN 13 : 9781571816016
Total Pages : 152 pages
Book Rating : 4.8/5 (16 download)

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Book Synopsis Issues in Medical Research Ethics by : Jürgen Boomgaarden

Download or read book Issues in Medical Research Ethics written by Jürgen Boomgaarden and published by Berghahn Books. This book was released on 2003 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethical and Regulatory Aspects of Clinical Research

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Publisher :
ISBN 13 :
Total Pages : 532 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Regulatory Aspects of Clinical Research by : Ezekiel J. Emanuel

Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.

Ethics Dumping

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Publisher : Springer
ISBN 13 : 3319647318
Total Pages : 144 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Ethics Dumping by : Doris Schroeder

Download or read book Ethics Dumping written by Doris Schroeder and published by Springer. This book was released on 2017-12-04 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.

Women and Health Research

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Author :
Publisher : National Academies Press
ISBN 13 : 030904992X
Total Pages : 286 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Women and Health Research by : Institute of Medicine

Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Drugs, Ethics, and Quality of Life

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Publisher : CRC Press
ISBN 13 : 1000572552
Total Pages : 352 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Drugs, Ethics, and Quality of Life by : Bruce White

Download or read book Drugs, Ethics, and Quality of Life written by Bruce White and published by CRC Press. This book was released on 2021-10-12 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Weigh pivotal healthcare ethics, law, and public policy issues that resulted in tipping-point legal actions Weighing the ethical considerations in healthcare and drug issues can be emotionally difficult and mentally challenging. Drugs, Ethics, and Quality of Life: Cases and Materials on Ethical, Legal, and Public Policy Dilemmas in Medicine and Pharmacy Practice is a fascinating casebook that clearly discusses the most contentious ethical conflicts that resulted in legal actions. This easy-to-read text provides all sides of controversial real-life cases that provoke spirited debate while teaching the fundamentals of pharmacy law and ethics. The book is a unique exploration into the basic principles of bioethics, end of life care, and drug research. Drugs, Ethics, and Quality of Life explains in detail the concepts of ethics, quality of life, beneficence, nonmaleficence, autonomy, and justice. Recent cases provide illuminating backdrops for the exploration of these concepts, making them easily understood. A special introduction includes important information about ethics and the pharmaceutical code of ethics. Two appendixes provide further opportunities for discussion and the examination of law and decisions, and resources about drug use decisions and situations. This thought-provoking textbook plainly shows the crucial role ethics plays in today’s society. Ethical topics explored in Drugs, Ethics, and Quality of Life includes legal cases on: tobacco COX-2 inhibitors medical marijuana the “morning after” pill and other emergency contraceptives pain medications and palliative care drugs physician-assisted suicide drug use in medically futile situations gene therapy Drugs, Ethics, and Quality of Life is valuable, insightful reading as well as a good adjunct text for pharmacy students, pharmacists, medical students, physicians, bio

The Oxford Textbook of Clinical Research Ethics

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Publisher : OUP USA
ISBN 13 : 0199768633
Total Pages : 848 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis The Oxford Textbook of Clinical Research Ethics by : Ezekiel J. Emanuel

Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

BioIndustry Ethics

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Publisher : Elsevier
ISBN 13 : 0080492517
Total Pages : 384 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis BioIndustry Ethics by : David L. Finegold

Download or read book BioIndustry Ethics written by David L. Finegold and published by Elsevier. This book was released on 2005-07-19 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first systematic, detailed treatment of the approaches to ethical issues taken by biotech and pharmaceutical companies. The application of genetic/genomic technologies raises a whole spectrum of ethical questions affecting global health that must be addressed. Topics covered in this comprehensive survey include considerations for bioprospecting in transgenics, genomics, drug discovery, and nutrigenomics, as well as how to improve stakeholder relations, design ethical clinical trials, avoid conflicts of interest, and establish ethics advisory boards. The expert authors represent multiple disciplines including law, medicine, bioinformatics, pharmaceutics, business, and ethics.

Field Trials of Health Interventions

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Publisher :
ISBN 13 : 0198732864
Total Pages : 479 pages
Book Rating : 4.1/5 (987 download)

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Book Synopsis Field Trials of Health Interventions by : Peter G. Smith

Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by . This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.

Ethics and Drug Resistance: Collective Responsibility for Global Public Health

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Author :
Publisher : Springer
ISBN 13 : 9783030278762
Total Pages : 448 pages
Book Rating : 4.2/5 (787 download)

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Book Synopsis Ethics and Drug Resistance: Collective Responsibility for Global Public Health by : Euzebiusz Jamrozik

Download or read book Ethics and Drug Resistance: Collective Responsibility for Global Public Health written by Euzebiusz Jamrozik and published by Springer. This book was released on 2021-08-21 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Open Access volume provides in-depth analysis of the wide range of ethical issues associated with drug-resistant infectious diseases. Antimicrobial resistance (AMR) is widely recognized to be one of the greatest threats to global public health in coming decades; and it has thus become a major topic of discussion among leading bioethicists and scholars from related disciplines including economics, epidemiology, law, and political theory. Topics covered in this volume include responsible use of antimicrobials; control of multi-resistant hospital-acquired infections; privacy and data collection; antibiotic use in childhood and at the end of life; agricultural and veterinary sources of resistance; resistant HIV, tuberculosis, and malaria; mandatory treatment; and trade-offs between current and future generations. As the first book focused on ethical issues associated with drug resistance, it makes a timely contribution to debates regarding practice and policy that are of crucial importance to global public health in the 21st century.