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Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
Accompanied by supplements.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
Accompanied by supplements.
Author: Stephen M. Kanovsky
Publisher:
ISBN: 9781935065876
Category : Drugs
Languages : en
Pages : 672
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Book Description
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Author: Lawrence X. Yu
Publisher: Springer
ISBN: 1493912526
Category : Medical
Languages : en
Pages : 472
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Book Description
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Author: Committee for the Substance Abuse Coverage Study
Publisher: National Academies Press
ISBN: 9780309043960
Category : Medical
Languages : en
Pages : 332
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Book Description
Treating Drug Problems, Volume 2 presents a wealth of incisive and accessible information on the issue of drug abuse and treatment in America. Several papers lay bare the relationship between drug treatment and other aspects of drug policy, including a powerful overview of twentieth century narcotics use in America and a unique account of how the federal government has built and managed the drug treatment system from the 1960s to the present. Two papers focus on the criminal justice system. The remaining papers focus on Employer policies and practices toward illegal drugs. Patterns and cycles of cocaine use in subcultures and the popular culture. Drug treatment from a marketing, supply-and-demand perspective, including an analysis of policy options. Treating Drug Problems, Volume 2 provides important information to policy makers and administrators, drug treatment specialists, and researchers.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038294
Category : Medical
Languages : en
Pages : 709
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Book Description
For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
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: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
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
Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
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Book Description
Author: David F. Musto
Publisher: Oxford University Press, USA
ISBN: 0195125096
Category : Medical
Languages : en
Pages : 431
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Book Description
The American Disease is a classic study of the development of drug laws in the United States. Supporting the theory that Americans' attitudes toward drugs have followed a cyclic pattern of tolerance and restraint, author David F. Musto examines the relationz between public outcry and the creation of prohibitive drug laws from the end of the Civil War up to the present. Originally published in 1973, and then in an expanded edition in 1987, this third edition contains a new chapter and preface that both address the renewed debate on policy and drug legislation from the end of the Reagan administration to the current Clinton administration. Here, Musto thoroughly investigates how our nation has dealt with such issues as the controversies over prevention programs and mandatory minimum sentencing, the catastrophe of the crack epidemic, the fear of a heroin revival, and the continued debate over the legalization of marijuana.
