Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64

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Book Description
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Off-label Prescribing

Off-label Prescribing PDF Author: David Cavalla
Publisher: John Wiley & Sons
ISBN: 1118912071
Category : Science
Languages : en
Pages : 211

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Book Description
Today’s medicines are regulated for their efficacy and safety and, once approved, they can be marketed for certain uses as justified by the data. Regulatory bodies in developed countries are constituted by legal statute and operate as parts of government, ostensibly in the interests of the people as patients. But once approved, medicines can be used for any purpose the prescriber thinks fit and appropriate for the patient. One in five prescriptions is therefore written outside regulatory purview. Off-label Prescribing looks into the corners of our medicated lives, where drug regulation runs up against medical practice, and concerns the use of a drug that has been approved for one use (in medical parlance, ‘indication’) being used for a different indication; alternatively, being used on a different set of patients from the ones it is approved for, or at a different dose. Usually the patient is unaware of what is going on, having not been informed by their doctor of this aspect of his or her prescribing choice. The book examines how and why this occurs, what the various medical professions have to say about it, and how pharmaceutical companies benefit by moving into this poorly regulated area. Off-label Prescribing pulls these complex issues together in one volume, to highlight current practice, its advantages and weaknesses and how the author suggests practice should evolve in the future. It will therefore be of interest to all those who prescribe (and receive) medicines, combined with a greater objective to provide more transparency and discussion for professionals.

Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64

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Book Description
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Prescription Drugs: Alternative Uses, Alternative Cures

Prescription Drugs: Alternative Uses, Alternative Cures PDF Author: Kevin R. Loughlin
Publisher: Simon and Schuster
ISBN: 0743286715
Category : Medical
Languages : en
Pages : 1715

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Book Description
This first-of-its-kind drug reference gives consumers an easy way to research the prescription drug options that might best suit their unique needs.

Legal and Forensic Medicine

Legal and Forensic Medicine PDF Author: Roy G. Beran
Publisher: Springer
ISBN: 9783642323379
Category : Medical
Languages : en
Pages : 0

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Book Description
This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.​

Ethical Issues in Mental Health

Ethical Issues in Mental Health PDF Author: Steve Baldwin
Publisher: Springer
ISBN: 1489932704
Category : Medical
Languages : en
Pages : 217

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Book Description
Why write another book on ethics? As practitioners we are involved both in the design and delivery of services to people with mental health problems. In common with all other professionals, our work has led to the experience of ethical dilemmas: typically, these have involved major confrontations, either with our col leagues or our consciences. This book, however, is not limited to a discussion of such major themes. Rather, we have tried to use a broader canvas: ethics, in our view, is really about the judgement of right and wrong in ordinary, everyday life. Ethics are highly personal: we fashion our own personal code from our experi ence of others, and from the 'tests' which bring meaning to our lives. Such experiences shape our individual values. We bring these codes and values to our work. We are not always aware of their influence in our dealings with people. Although we may not always be aware of it, all our actions pose an ethical question. Given that our work involves us in helping others to live ordinary, satisfying lives, this challenge heightens the intensity of our ethical dilemmas. This is most evident where our personal code conflicts with the implicit code of the health setting.

Health Literacy

Health Literacy PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309371570
Category : Medical
Languages : en
Pages : 190

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Book Description
In 2004, the Institute of Medicine released Health Literacy: A Prescription to End Confusion, a report on the then-underappreciated challenge of enabling patients to comprehend their condition and treatment, to make the best decisions for their care, and to take the right medications at the right time in the intended dose. That report documented the problems, origins, and consequences of the fact that tens of millions of U.S. adults are unable to read complex texts, including many health-related materials, and it proposed possible solutions to those problems. To commemorate the anniversary of the release of the 2004 health literacy report, the Institute of Medicine's Roundtable on Health Literacy convened a 1-day public workshop to assess the progress made in the field of health literacy over the past decade, the current state of the field, and the future of health literacy at the local, national, and international levels. Health Literacy: Past, Present, and Future summarizes the presentation and discussion of the workshop.

Oxford Textbook of Global Public Health

Oxford Textbook of Global Public Health PDF Author: Roger Detels
Publisher: Oxford University Press
ISBN: 019881013X
Category : Medical
Languages : en
Pages : 1717

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Book Description
Sixth edition of the hugely successful, internationally recognised textbook on global public health and epidemiology, with 3 volumes comprehensively covering the scope, methods, and practice of the discipline

Drug Safety

Drug Safety PDF Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 12

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Book Description


Innovation in Medical Technology

Innovation in Medical Technology PDF Author: Margaret L. Eaton
Publisher: JHU Press
ISBN: 9780801885266
Category : Law
Languages : en
Pages : 188

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Book Description
This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.

Direct Oral Anticoagulants

Direct Oral Anticoagulants PDF Author: Riccardo Proietti
Publisher: Springer Nature
ISBN: 3030744620
Category : Medical
Languages : en
Pages : 283

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Book Description
This book concisely covers the latest developments in the application of direct oral anticoagulants (DOACs) within cardiovascular medicine. It details the pharmacodynamics and pharmacokinetic mechanisms of DOACs and their application in treating patients with conditions ranging from coronary heart disease through kidney disease and cancer, including their perioperative management. Direct Oral Anticoagulants: From Pharmacology to Clinical Practice systematically describes the underlying mechanisms associated with DOACs and their use to treat a range of conditions and is an indispensable resource for all trainee and practicing physicians in a range of disciplines seeking a concise up-to-date resource on the topic.