Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309142318
Category : Medical
Languages : en
Pages : 101

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Book Description
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309142318
Category : Medical
Languages : en
Pages : 101

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Book Description
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Catalog of Copyright Entries

Catalog of Copyright Entries PDF Author: Library of Congress. Copyright Office
Publisher:
ISBN:
Category : Copyright
Languages : en
Pages : 1118

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Book Description


Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107

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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.

Drugs without the hot air

Drugs without the hot air PDF Author: David Nutt
Publisher: Bloomsbury Publishing
ISBN: 0857844962
Category : Medical
Languages : en
Pages : 449

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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'.

The Orange Book

The Orange Book PDF Author: Richard McGuire
Publisher:
ISBN: 9788875702021
Category :
Languages : it
Pages : 32

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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

Informing the Future

Informing the Future PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309215366
Category : Medical
Languages : en
Pages : 203

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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.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151

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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.

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

Building a National Framework for the Establishment of Regulatory Science for Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158893
Category : Medical
Languages : en
Pages : 94

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Book Description
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.

WHO Expert Committee on Drug Dependence

WHO Expert Committee on Drug Dependence PDF Author:
Publisher: World Health Organization
ISBN: 924002302X
Category : Law
Languages : en
Pages : 215

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Book Description
This report presents the recommendations of the forty-third Expert Committee on Drug Dependence (ECDD). The ECDD is responsible for the assessment of psychoactive substances for possible scheduling under the International Drug Control Conventions. The ECDD reviews the therapeutic usefulness, the liability for abuse and dependence, and the public health and social harm of each substance. The ECDD advises the Director-General of WHO to reschedule or to amend the scheduling status of a substance. The Director-General will, as appropriate, communicate the recommendations to the Secretary-General of the United Nations, who will in turn communicate the advice to the Commission on Narcotic Drugs. This report summarizes the findings of the forty-third meeting at which the Committee reviewed 11 psychoactive substances: – 5-Methoxy-N,N-diallyltryptamine (5-MeO-DALT) – 3-Fluorophenmetrazine (3-FPM) – 3-Methoxyphencyclidine (3-MeO-PCP) – Diphenidine – 2-Methoxydiphenidine (2-MeO-DIPHENIDINE) – Isotonitazene – MDMB-4en-PINACA – CUMYL-PEGACLONE – Flubromazolam – Clonazolam – Diclazepam The report also contains the critical review documents that informed recommendations made by the ECDD regarding international control of those substances.

Drug Misuse and Motherhood

Drug Misuse and Motherhood PDF Author: Marcia Jackson
Publisher: Routledge
ISBN: 1134485913
Category : Medical
Languages : en
Pages : 332

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Book Description
The inadequacy of drug treatment services for women is an international issue, noted at all major conferences The needs of women have assumed an increasingly important part of the range of topics for further research and attention by service providers and policy makers There is a great lack of information in this field and this book will fill that gap