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      • Trusted Partner
        On trial
        Medicine
        July 2024

        On trial

        Testing new drugs in psychiatry, 1940–1980

        by Marietta Meier, Magaly Tornay, Mario König

        The heroic story of the invention of antidepressants is a key part of the psychopharmaceutical turn. On Trial revolves around one of its pioneers, psychiatrist Roland Kuhn, who practiced in Münsterlingen, a state-run psychiatric hospital in Switzerland. Kuhn became famous for the 'discovery' of the first antidepressant, Tofranil, and more recently notorious for his numerous trials on often unsuspecting patients. Largely based on the extensive and previously inaccessible sources of Kuhn's private archive, the book delves into the early days of industry-sponsored clinical research in psychiatry. It examines how the clinic, patients, doctors, nursing staff, corporations, and authorities interacted in the trials. Conducted from the 1940s to 1980s, the Münsterlingen drug trials are historicised and situated in the period's evolving landscape of experimentation.

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      • Procedures for Testing Color Vision
        Pharmacology
        January 1981

        Procedures for Testing Color Vision

        Report of Working Group 41

        by Committee on Vision, National Research Council

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      • Electronic Travel Aids
        Pharmacology
        January 1986

        Electronic Travel Aids

        New Directions for Research

        by Working Group on Mobility Aids for the Visually Impaired and Blind, Committee on Vision

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      • Medical Technology Assessment Directory
        Pharmacology
        January 1988

        Medical Technology Assessment Directory

        A Pilot Reference to Organizations, Assessments, and Information Resources

        by Council on Health Care Technology

        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.

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      • New Medical Devices
        Pharmacology
        January 1988

        New Medical Devices

        Invention, Development, and Use

        by National Academy of Engineering, Institute of Medicine

        In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

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      • Broadening the Base of Treatment for Alcohol Problems
        Pharmacology
        January 1990

        Broadening the Base of Treatment for Alcohol Problems

        by Committee on Treatment of Alcohol Problems, Institute of Medicine

        In this congressionally mandated study, an expert committee of the Institute of Medicine takes a close look at where treatment for people with alcohol problems seems to be headed, and provides its best advice on how to get there. Careful consideration is given to how the creative growth of treatment can best be encouraged while keeping costs within reasonable limits. Particular attention is devoted to the importance of developing therapeutic approaches that are sensitive to the special needs of the many diverse groups represented among those who have developed problems related to their use of "man's oldest friend and oldest enemy." This book is the most comprehensive examination of alcohol treatment to date.

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      • Quality of Life and Technology Assessment
        Pharmacology
        January 1989

        Quality of Life and Technology Assessment

        by Council on Health Care Technology, Institute of Medicine

        The field of health care technology assessment focuses on the use of medical technologies--their impacts on safety, efficacy, and effectiveness; cost-effectiveness and cost benefit; quality; and their social, legal, and ethical implications. This wide-ranging monograph addresses some of the gaps in understanding health status and quality of life, such as the use of quality-of-life measures in technology assessment, organ transplantation, and pharmaceutical trials. One chapter provides basic references for the technical attributes of many established measures and some lesser known ones. The final chapter offers recommendations concerning the appropriate applications of these measures and highlights areas for cooperative research.

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      • Contact Lens Use Under Adverse Conditions
        Pharmacology
        January 1990

        Contact Lens Use Under Adverse Conditions

        Applications in Military Aviation

        by Working Group on Contact Lens Use Under Adverse Conditions, Committee on Vision, National Research Council

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      • Setting Priorities for Health Technologies Assessment
        Pharmacology
        January 1992

        Setting Priorities for Health Technologies Assessment

        A Model Process

        by Molla S. Donaldson and Harold C. Sox, Jr., Editors; Committee on Priorities for Assessment and Reassessment of Health Care Technologies, Institute of Medicine

        The problem of deciding which health care technologies to evaluate is urgent. With new technologies proliferating alongside steadily increasing health care costs, it is critical to discriminate among technologies to direct tests and treatments at those who can benefit the most. Given the vast number of clinical problems and technologies to be evaluated, the many months of work required to study just one problem, and the relatively few clinicians with highly developed analytic skills, institutions must set priorities for assessment. This book sets forth criteria and a method that can be used by public agencies such as the Office of Health Technology Assessment (in the U.S. Public Health Service) and by any private organization conducting such work to decide which technologies to assess or reassess.

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      • Sources of Medical Technology
        Pharmacology
        January 1995

        Sources of Medical Technology

        Universities and Industry

        by Nathan Rosenberg, Annetine C. Gelijns, and Holly Dawkins, Editors; Committee on Technological Innovation in Medicine, Institute of Medicine

        Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.

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      • The Development of Medications for the Treatment of Opiate and Cocaine Addictions
        Pharmacology
        January 1995

        The Development of Medications for the Treatment of Opiate and Cocaine Addictions

        Issues for the Government and Private Sector

        by Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, Editors; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Institute of Medicine

        Pharmacotherapy, as a means of treating drug addiction in combination with other treatment modalities, has received too little attention from the research community, the pharmaceutical industry, public health officials, and the federal government. Medications to combat drug addiction could have an enormous impact on the medical consequences and socioeconomic problems associated with drug abuse, both for drug-dependent individuals and for American society as a whole. This book examines the current environment for and obstacles to the development of anti-addiction medications, specifically those for treating opiate and cocaine addictions, and proposes incentives for the pharmaceutical industry that would help overcome those obstacles and accelerate the development of anti-addiction medications.

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      • Radiation in Medicine
        Pharmacology
        March 1996

        Radiation in Medicine

        A Need for Regulatory Reform

        by Kate-Louise D. Gottfried and Gary Penn, Editors; Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission, Institute of Medicine

        Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.

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      • Telemedicine
        Pharmacology
        October 1996

        Telemedicine

        A Guide to Assessing Telecommunications for Health Care

        by Marilyn J. Field, Editor; Committee on Evaluating Clinical Applications of Telemedicine, Institute of Medicine

        Telemedicine--the use of information and telecommunications technologies to provide and support health care when distance separates the participants--is receiving increasing attention not only in remote areas where health care access is troublesome but also in urban and suburban locations. Yet the benefits and costs of this blend of medicine and digital technologies must be better demonstrated before today's cautious decisionmakers invest significant funds in its development. Telemedicine presents a framework for evaluating patient care applications of telemedicine. The book identifies managerial, technical, policy, legal, and human factors that must be taken into account in evaluating a telemedicine program. The committee reviews previous efforts to establish evaluation frameworks and reports on results from several completed studies of image transmission, consulting from remote locations, and other telemedicine programs. The committee also examines basic elements of an evaluation and considers relevant issues of quality, accessibility, and cost of health care. Telemedicine will be of immediate interest to anyone with interest in the clinical application of telemedicine.

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      • Xenotransplantation
        Pharmacology
        July 1996

        Xenotransplantation

        Science, Ethics, and Public Policy

        by Committee on Xenograft Transplantation: Ethical Issues and Public Policy, Institute of Medicine

        Xenotransplantation involves the transplantation of cells, tissues, and whole organs from one species to another. Interest in animal-to-human xenotransplants has been spurred by the continuing shortage of donated human organs and by advances in knowledge concerning the biology of organ and tissue rejection. The scientific advances and promise, however, raise complex questions that must be addressed. This book considers the scientific and medical feasibility of xenotransplantation and explores the ethical and public policy issues surrounding the possibility of renewed clinical trials. The volume focuses on the science base of xenotransplantation, public health risks of infectious disease transmission, and ethical and public policy issues, including the views of patients and their families.

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      • Public Health Effectiveness of the FDA 510(k) Clearance Process
        Pharmacology
        October 2010

        Public Health Effectiveness of the FDA 510(k) Clearance Process

        Balancing Patient Safety and Innovation: Workshop Report

        by Theresa Wizemann, Editor; Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Institute of Medicine

        The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

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      • Building a National Framework for the Establishment of Regulatory Science for Drug Development
        Pharmacology
        February 2011

        Building a National Framework for the Establishment of Regulatory Science for Drug Development

        Workshop Summary

        by Yeonwoo Lebovitz, Rebecca English, and Anne Claiborne; Forum on Drug Discovery, Development, and Translation; Institute of Medicine

        The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.

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      • Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development
        Pharmacology
        February 2011

        Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development

        Workshop Summary

        by Steve Olson and Adam Berger, Rapporteurs; Roundtable on Translating Genomic-Based Research on Health; Institute of Medicine

        Despite the many basic research discoveries in genetics, relatively few gene-based treatments, drugs, or preventative measures have been developed. One way to bridge this gap may be for industry, academia, and government to develop partnerships that share resources while distributing risk. However, intellectual property protections and other barriers can inhibit collaborative efforts. The Institute of Medicine held a workshop on July 22, 2010, to explore these issues and develop solutions.

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      • Perspectives on Biomarker and Surrogate Endpoint Evaluation
        Pharmacology
        January 2011

        Perspectives on Biomarker and Surrogate Endpoint Evaluation

        Discussion Forum Summary

        by Alison Mack, Erin Balogh, and Christine Micheel, Rapporteurs; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease; Institute of Medicine

        In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.

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