Author: Publisher:
ISBN:
Category : Drug abuse
Languages : en
Pages : 426
Book Description
Drug Forum
Author: Transforming Clinical Research in the United States
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151
Book Description
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
The Orange Book
Author: Richard McGuirePublisher:
ISBN: 9788875702021
Category :
Languages : it
Pages : 32
Book Description
Ecco un albero con 14 succose arance. Una per una, i loro destini si rivelano nelle pagine del libro: la prima è stata portata ad un amico malato, la settima è stata divisa tra compagni di lavoro, la decima è stata mangiata da un famoso pianista. E naturalmente, la quattordicesima è stata comprata da qualcuno che conosci e potrebbe essere la prossima che mangerai. Ogni arancia è una forma arancione su uno sfondo semplice ed essenziale disegnato a matita blu, popolato di personaggi e situazioni di tutti i giorni, su cui risalta creando un collegamento visivo ed espressivo continuo. Annotation Supplied by Informazioni Editoriali
Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 118
Book Description
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.
Pediatric Drug Development
Author: Andrew E. MulbergPublisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782
Book Description
Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
Drug Forum
Author: Drugs without the hot air
Author: David NuttPublisher: Bloomsbury Publishing
ISBN: 0857844962
Category : Medical
Languages : en
Pages : 449
Book Description
The dangers of illegal drugs are well known and rarely disputed, but how harmful are alcohol and tobacco by comparison? The issue of what a drug is and how we should live with them affects us all: parents, teachers, users – anyone who has taken a painkiller or drunk a glass of wine. Written by renowned psychiatrist, Professor David Nutt, Drugs without the hot air casts a refreshingly honest light on drugs and answers crucial questions that are rarely ever disputed. What are we missing by banning medical research into magic mushrooms, LSD and cannabis? Can they be sources of valuable treatments? How can psychedelics treat depression? Drugs without the hot air covers a wide range of topics, from addiction and whether addictive personalities exist to the role of cannabis in treating epilepsy, an overview on the opioid crisis, and an assessment of how harmful vaping is. This new expanded and revised second edition includes even more details on international policies, particularly in the US. David's research has won international support, reducing drug-related harm by introducing policies that are founded on scientific evidence. But there is still a lot to be done. Accessibly written, this much-awaited second edition is an important book for everyone that brings us all up to date with the 'war of drugs'.
Informing the Future
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309215366
Category : Medical
Languages : en
Pages : 203
Book Description
This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.
The Drug Development Paradigm in Oncology
Author: National Academies of Sciences, Engineering, and MedicinePublisher: National Academies Press
ISBN: 0309457971
Category : Medical
Languages : en
Pages : 145
Book Description
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Model Rules of Professional Conduct
Author: American Bar Association. House of DelegatesPublisher: American Bar Association
ISBN: 9781590318737
Category : Law
Languages : en
Pages : 216
Book Description
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
