Drug Standards

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Federal Regulation of Methadone Treatment

Author : Committee on Federal Regulation of Methadone Treatment
Publisher : National Academies Press
ISBN 13 : 0309598621
Total Pages : 251 pages
Book Rating : 4.3/5 (95 download)

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Book Synopsis Federal Regulation of Methadone Treatment by : Committee on Federal Regulation of Methadone Treatment

Download or read book Federal Regulation of Methadone Treatment written by Committee on Federal Regulation of Methadone Treatment and published by National Academies Press. This book was released on 1995-02-01 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.

Approved Prescription Drug Products

Author :
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Approved Prescription Drug Products by :

Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.

Quality and cost standards for drugs

Author : United States. Task Force on Prescription Drugs
Publisher :
ISBN 13 :
Total Pages : 34 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Quality and cost standards for drugs by : United States. Task Force on Prescription Drugs

Download or read book Quality and cost standards for drugs written by United States. Task Force on Prescription Drugs and published by . This book was released on 1969 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Drug Standards

Author : American Pharmaceutical Association. Committee on National Formulary
Publisher :
ISBN 13 :
Total Pages : 184 pages
Book Rating : 4.U/5 (183 download)

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Book Synopsis Drug Standards by : American Pharmaceutical Association. Committee on National Formulary

Download or read book Drug Standards written by American Pharmaceutical Association. Committee on National Formulary and published by . This book was released on 1960 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

Author : Stephen M. Kanovsky
Publisher :
ISBN 13 : 9781935065876
Total Pages : 672 pages
Book Rating : 4.0/5 (658 download)

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Book Synopsis A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition by : Stephen M. Kanovsky

Download or read book A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Fourth Interim Report

Author : United States. Task Force on Prescription Drugs
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Fourth Interim Report by : United States. Task Force on Prescription Drugs

Download or read book Fourth Interim Report written by United States. Task Force on Prescription Drugs and published by . This book was released on 1969 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Treating Drug Problems:

Author : Committee for the Substance Abuse Coverage Study
Publisher : National Academies Press
ISBN 13 : 9780309043960
Total Pages : 332 pages
Book Rating : 4.0/5 (439 download)

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Book Synopsis Treating Drug Problems: by : Committee for the Substance Abuse Coverage Study

Download or read book Treating Drug Problems: written by Committee for the Substance Abuse Coverage Study and published by National Academies Press. This book was released on 1992-01-01 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

FDA Bioequivalence Standards

Author : Lawrence X. Yu
Publisher : Springer
ISBN 13 : 1493912526
Total Pages : 472 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis FDA Bioequivalence Standards by : Lawrence X. Yu

Download or read book FDA Bioequivalence Standards written by Lawrence X. Yu and published by Springer. This book was released on 2014-09-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

New Drug Regulations Under the Federal Food, Drug and Cosmetic Act

Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 150 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis New Drug Regulations Under the Federal Food, Drug and Cosmetic Act by : United States. Food and Drug Administration

Download or read book New Drug Regulations Under the Federal Food, Drug and Cosmetic Act written by United States. Food and Drug Administration and published by . This book was released on 1967 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Nurse's Role in Medication Safety

Author : Laura Cima
Publisher : Joint Commission Resources
ISBN 13 : 1599406187
Total Pages : 179 pages
Book Rating : 4.5/5 (994 download)

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Book Synopsis The Nurse's Role in Medication Safety by : Laura Cima

Download or read book The Nurse's Role in Medication Safety written by Laura Cima and published by Joint Commission Resources. This book was released on 2011-12 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written especially for nurses in all disciplines and health care settings, this second edition of The Nurses's Role in Medication Safety focuses on the hands-on role nurses play in the delivery of care and their unique opportunity and responsibility to identify potential medication safety issues. Reflecting the contributions of several dozen nurses who provided new and updated content, this book includes strategies, examples, and advice on how to: * Develop effective medication reconciliation processes * Identify and address causes of medication errors * Encourage the reporting of medication errors in a safe and just culture * Apply human factors solutions to medication management issues and the implementation of programs to reduce medication errors * Use technology (such as smart pumps and computerized provider order entry) to improve medication safety * Recognize the special issues of medication safety in disciplines such as obstetrics, pediatrics, geriatrics, and oncology and within program settings beyond large urban hospitals, including long term care, behavioral health care, critical access hospitals, and ambulatory care and office-based surgery

Drug Standards

Author : American Pharmaceutical Association
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (954 download)

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Book Synopsis Drug Standards by : American Pharmaceutical Association

Download or read book Drug Standards written by American Pharmaceutical Association and published by . This book was released on 1932 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration

Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 82 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration by : United States. Food and Drug Administration

Download or read book Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration written by United States. Food and Drug Administration and published by . This book was released on 1979 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Technology Assessment Directory

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309038294
Total Pages : 709 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Medical Technology Assessment Directory by : Institute of Medicine

Download or read book Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The History of the Development of Drug Standards in the United States

Author : Frank Stuart McGinnis
Publisher :
ISBN 13 :
Total Pages : 326 pages
Book Rating : 4.:/5 (123 download)

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Book Synopsis The History of the Development of Drug Standards in the United States by : Frank Stuart McGinnis

Download or read book The History of the Development of Drug Standards in the United States written by Frank Stuart McGinnis and published by . This book was released on 1944 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Managed Care Pharmacy Practice

Author : Navarro
Publisher : Jones & Bartlett Publishers
ISBN 13 : 076378883X
Total Pages : 659 pages
Book Rating : 4.7/5 (637 download)

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Book Synopsis Managed Care Pharmacy Practice by : Navarro

Download or read book Managed Care Pharmacy Practice written by Navarro and published by Jones & Bartlett Publishers. This book was released on 2008-12-11 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managed Care Pharmacy Practice, Second Edition offers information critical to the development and operation of a managed care pharmacy program. The text also covers the changes that have taken place within the delivery of pharmacy services, as well as the evolving role of pharmacists.