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Evidence-based medicine. --- Drug approval.

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Drugs --- Biologicals --- Medical instruments and apparatus --- Drug Approval --- Equipment and Supplies --- Quality control --- Quality control. --- Canada. --- Canada

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Therapeutics --- Drugs --- Thérapeutique --- Médicaments --- History --- Testing --- Law and legislation --- Histoire --- Essais cliniques --- Droit --- Législation --- Drug therapy --- Clinical trials as topic --- Drug approval --- History, 20th century --- Essais cliniques des médicaments --- Histoire du 20ème siècle --- Études cliniques --- Relations interprofessionnelles dans le domaine de la santé --- history --- United States. --- Thérapeutique --- Médicaments --- Législation --- Drug Therapy --- Clinical Trials as Topic --- history. --- Drug Approval --- History, 20th Century. --- Histoire. --- History, 20th Century --- United States --- Essais cliniques comme sujet --- Médecine --- Histoire médecine --- Recherche --- États-Unis

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"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."--

Clinical trials -- Congresses. --- Drug approval -- Congresses. --- Drug development -- Congresses. --- Drug development --- Neuropharmacology --- Drugs --- Clinical trials --- Neurosciences --- Chemistry, Pharmaceutical --- Epidemiologic Study Characteristics as Topic --- Investigative Techniques --- Drug Therapy --- Diseases --- Evaluation Studies as Topic --- Therapeutics --- Epidemiologic Methods --- Health Care Evaluation Mechanisms --- Chemistry --- Pharmacology --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Natural Science Disciplines --- Public Health --- Biological Science Disciplines --- Quality of Health Care --- Health Care Quality, Access, and Evaluation --- Disciplines and Occupations --- Environment and Public Health --- Health Care --- Models, Animal --- Clinical Trials as Topic --- Drug Delivery Systems --- Nervous System Diseases --- Drug Discovery --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Research --- Testing --- Drug approval --- Neurosciecnes

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"The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop"--

Drug development -- Congresses. --- Drug development --- Drugs --- Drug approval --- Social Sciences --- Drug Discovery --- Chemicals and Drugs --- Evaluation Studies as Topic --- Social Control, Formal --- Legislation as Topic --- Chemistry, Pharmaceutical --- Sociology --- Anthropology, Education, Sociology and Social Phenomena --- Investigative Techniques --- Health Care Economics and Organizations --- Chemistry --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Pharmacology --- Health Care --- Natural Science Disciplines --- Biological Science Disciplines --- Disciplines and Occupations --- Drug Design --- Legislation, Drug --- Internationality --- Pharmaceutical Preparations --- Drug Evaluation --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Standards --- Testing --- Methods