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Author: Marian Segal
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 4
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Book Description
Author: Marian Segal
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 4
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Book Description
Author: Craig E. Hammer
Publisher:
ISBN:
Category :
Languages : en
Pages : 203
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
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Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
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Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author: Tony Ellery
Publisher: John Wiley & Sons
ISBN: 0470487534
Category : Medical
Languages : en
Pages : 412
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Book Description
A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.
Author: W Steven Pray
Publisher: CRC Press
ISBN: 9780789015389
Category : Medical
Languages : en
Pages : 306
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Book Description
Follow the course of the battle to protect American consumers from unsafe and ineffective nonprescription pharmaceutical products! A History of Nonprescription Product Regulation explores the regulation of nonprescription products in the United States via an examination of the circumstances surrounding the passage of various laws. It untangles the process by which those bills became law, beginning with early federal regulations and moving through the laws that were passed in 1906 and 1938 and the amendments that came in 1951 and 1962. It relates important issues of the day (muckraking, sulfanilamide, thalidomide) to those laws by carefully describing their influence on pending legislation. In its coverage of the laws that govern nonprescription products, A History of Nonprescription Product Regulation makes extensive use of widely varied source material that gives the book a contemporary tone that is quite unique in texts of this kind. For instance, the reader wishing to more fully understand the 1906 Pure Food and Drug Act will be treated to a view of that act drawn from the pages of The New York Times, the Congressional Record, and various journals that were published while the act was being debated. In A History of Nonprescription Product Regulation, you will find clearly written chapters covering: how prescription medications differ from nonprescription products early food and drug regulations established by the federal government patent medicines the Pure Food and Drug Law of 1906 the Harrison Narcotic Act of 1914 the federal Food, Drug, and Cosmetic Act of 1938 the Kefauver-Harris Amendments of 1962 Rx-to-OTC switching and the FDA's review of over-the-counter products regulations relating to homeopathy and dietary supplements Well-referenced and richly complemented with dozens of photographs, this essential volume illuminates the struggle—on many fronts—to achieve a situation in which the American consumer can purchase safe and effective nonprescription products.
Author: Carrie Markgraf
Publisher: Academic Press
ISBN: 0124202160
Category : Medical
Languages : en
Pages : 321
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Book Description
Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy
Author: United States Pharmacopeial Convention
Publisher:
ISBN:
Category : Pharmacy
Languages : en
Pages : 576
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Book Description
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.
Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292
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Book Description
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
