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Author : Frank Stuart McGinnis
Publisher :
ISBN 13 :
Total Pages : 326 pages
Book Rating : 4.:/5 (123 download)
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:
Author : Richard Henry Parrish II
Publisher : Routledge
ISBN 13 : 1351523147
Total Pages : 275 pages
Book Rating : 4.3/5 (515 download)
Download or read book Defining Drugs written by Richard Henry Parrish II and published by Routledge. This book was released on 2017-09-25 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-related morbidity and mortality is rampant in contemporary industrial society, despite or perhaps because, government has assumed a critical role in the process by which drugs are developed and approved. Parrish asserts that, as a people, Americans need to understand how it is that government became the arbiter of pharmaceutical fact. The consequences of our failure to understand, he argues, may threaten individual choice and forestall the development of responsible therapeutics. Moreover, if current standards and control continues unabated, the next therapeutic reformation might well make possible the sanctioned commercial exploitation of patients. In Defining Drugs, Parrish argues that the federal government became arbiter of pharmaceutical fact because the professions of pharmacy and medicine, as well as the pharmaceutical industry, could enforce these definitions and standards only through police powers reserved to government. Parrish begins his provocative study by examining the development of the social system for regulating drug therapy in the United States. He reviews the standards that were negotiated, and the tensions of the period between Progressivism and the New Deal that gave cultural context and historical meaning to drug use in American society. Parrish describes issues related to the development of narcotics policy through education and legislation facilitated by James Beal and Edward Kremers, and documents the federal government's evolving role as arbiter of market tensions between pharmaceutical producers, government officials, and private citizens in professional groups, illustrating the influence of government in writing enforceable standards for pharmaceutical therapies. He shows how the expansion of political rights for practitioners and producers has shifted responsibility for therapeutic consequences from individual practitioners and patients to government. This timely and controversial volume is written for the scholar and the compassionate practitioner alike, and a general public concerned with pharmacy regulation in a free society.
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)
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.
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)
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.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : Dominique A. Tobbell
Publisher : Univ of California Press
ISBN 13 : 0520271130
Total Pages : 310 pages
Book Rating : 4.5/5 (22 download)
Download or read book Pills, Power, and Policy written by Dominique A. Tobbell and published by Univ of California Press. This book was released on 2012 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Tobbell analyzes the political and economic history of the alignment of the pharmaceutical industry, academic institutions and their faculty and organized medicine. This book is essential reading for policymakers and their staff as well as persons who study the history of health policy and those who contribute to it through medical research, advocacy and journalism. " -Daniel Fox, author of The Convergence of Science and Governance: Research, Health Policy, and American States "Dominique Tobbell’s vivid, balanced and probing account of pharmaceutical politics is a significant, needed analysis of the relationships between the pharmaceutical industry, university researchers, the medical profession and government in the Cold War period. More than this, Pills, Power, and Policy shows why it continues to be difficult to agree in the United States on the relative roles of corporate enterprise, government regulation, technological innovation, freedom to prescribe, and consumer marketing and protection, all played out against the rising costs of health care. Timely and thought-provoking."--Rosemary A. Stevens. DeWitt Wallace Distinguished Scholar, Department of Psychiatry, Weill Cornell Medical College "A superb and compelling account of the creation of one of America’s most reviled entities: Big Pharma. With clarity and subtlety, Pills, Power, and Policy weaves together the political, economic, and the medical to reveal the entangled history behind our modern pharmaceutical predicament."--Andrea Tone, Ph.D., Professor of History & Canada Research Chair in the Social History of Medicine, McGill University “Pills, Power and Policy provides an outstanding description and analysis of the evolution of drug policy. It is an extremely important contribution to our understanding of the political, scientific, and economic nature of pharmaceutical regulation." -Daniel S. Greenberg, Washington journalist and author of Science, Money and Politics: Political Triumph and Ethical Erosion
Author : Robert M. Elenbaas
Publisher :
ISBN 13 : 9781939862907
Total Pages : pages
Book Rating : 4.8/5 (629 download)
Download or read book Clinical Pharmacy in the United States written by Robert M. Elenbaas and published by . This book was released on 2019-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309046289
Total Pages : 337 pages
Book Rating : 4.3/5 (9 download)
Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309048370
Total Pages : 239 pages
Book Rating : 4.3/5 (9 download)
Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author : Mark A.R. Kleiman
Publisher : Oxford University Press
ISBN 13 : 0199831386
Total Pages : 258 pages
Book Rating : 4.1/5 (998 download)
Download or read book Drugs and Drug Policy written by Mark A.R. Kleiman and published by Oxford University Press. This book was released on 2011-07-13 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: While there have always been norms and customs around the use of drugs, explicit public policies--regulations, taxes, and prohibitions--designed to control drug abuse are a more recent phenomenon. Those policies sometimes have terrible side-effects: most prominently the development of criminal enterprises dealing in forbidden (or untaxed) drugs and the use of the profits of drug-dealing to finance insurgency and terrorism. Neither a drug-free world nor a world of free drugs seems to be on offer, leaving citizens and officials to face the age-old problem: What are we going to do about drugs? In Drugs and Drug Policy, three noted authorities survey the subject with exceptional clarity, in this addition to the acclaimed series, What Everyone Needs to Know®. They begin, by defining "drugs," examining how they work in the brain, discussing the nature of addiction, and exploring the damage they do to users. The book moves on to policy, answering questions about legalization, the role of criminal prohibitions, and the relative legal tolerance for alcohol and tobacco. The authors then dissect the illicit trade, from street dealers to the flow of money to the effect of catching kingpins, and show the precise nature of the relationship between drugs and crime. They examine treatment, both its effectiveness and the role of public policy, and discuss the beneficial effects of some abusable substances. Finally they move outward to look at the role of drugs in our foreign policy, their relationship to terrorism, and the ugly politics that surround the issue. Crisp, clear, and comprehensive, this is a handy and up-to-date overview of one of the most pressing topics in today's world. What Everyone Needs to Know® is a registered trademark of Oxford University Press.
Author : Benjamin E. Blass
Publisher : Academic Press
ISBN 13 : 0128172150
Total Pages : 738 pages
Book Rating : 4.1/5 (281 download)
Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator's fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist's early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. - Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property - Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape - Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery - Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry
Author : David F. Musto
Publisher : Oxford University Press, USA
ISBN 13 : 0195125096
Total Pages : 431 pages
Book Rating : 4.1/5 (951 download)
Download or read book The American Disease written by David F. Musto and published by Oxford University Press, USA. This book was released on 1999 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Steven Belenko
Publisher : Greenwood
ISBN 13 :
Total Pages : 424 pages
Book Rating : 4.3/5 (91 download)
Download or read book Drugs and Drug Policy in America written by Steven Belenko and published by Greenwood. This book was released on 2000-03-30 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Court cases, speeches, laws, opinion pieces, and other documents bring to life the controversies surrounding the issues. Explanatory introductions to documents aid users in understanding the various arguments put forth while illuminating the significance of each document."--BOOK JACKET.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author : Raymond G Hill
Publisher : Elsevier Health Sciences
ISBN 13 : 0702053163
Total Pages : 361 pages
Book Rating : 4.7/5 (2 download)
Download or read book Drug Discovery and Development - E-Book written by Raymond G Hill and published by Elsevier Health Sciences. This book was released on 2012-07-20 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. - The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ? non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ? Visiting Industrial Professor of Pharmacology in the University of Bristol ? Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ? Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ? President and Chair of the Council of the British Pharmacological Society ? member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: - Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. - New topic - DMPK Optimization Strategy in drug discovery. - New chapter on Scaffolds: Small globular proteins as antibody substitutes. - Totally updated chapters on Intellectual Property and Marketing - 50 new illustrations in full colour Features - Accessible, general guide to pharmaceutical research and development. - Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. - Written by a strong team of scientists with long experience in the pharmaceutical industry. - Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: '... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. - Highly Commended in the medicine category of the BMA 2006 medical book competition - Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year
