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Author: Uwe Marx
Publisher: John Wiley & Sons
ISBN: 3527609563
Category : Science
Languages : en
Pages : 318
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Book Description
Here, expert scientists from industry and academia share their knowledge on the assembly of functional human tissues in vitro and how to design drug screenings predictive of human exposure. In so doing, they combine the latest technological developments with strategic outlooks, such as novel cell and tissue systems for drug screening and testing, as well as emerging in vitro culture technologies. Equally importantly, the book does not shy away from regulatory acceptance and ethical issues.
Author: Uwe Marx
Publisher: John Wiley & Sons
ISBN: 3527609563
Category : Science
Languages : en
Pages : 318
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Book Description
Here, expert scientists from industry and academia share their knowledge on the assembly of functional human tissues in vitro and how to design drug screenings predictive of human exposure. In so doing, they combine the latest technological developments with strategic outlooks, such as novel cell and tissue systems for drug screening and testing, as well as emerging in vitro culture technologies. Equally importantly, the book does not shy away from regulatory acceptance and ethical issues.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
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Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author: Ann H. Crowe
Publisher:
ISBN:
Category : Drug abuse and crime
Languages : en
Pages : 96
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111
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Book Description
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Author: Alain G. Verstraete
Publisher: Pharmaceutical Press
ISBN: 0853696942
Category : Business & Economics
Languages : en
Pages : 461
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Book Description
This comprehensive text provides clear explanations of the effects of drugs on human performance and the need for workplace drug testing. It provides essential information on the regulatory and legal frameworks around the world, how to set policies and coverage of all aspects of drug analysis and the associated interpretation of results.Contents include:* epidemiology of drug use in the working population* the evidence base and guidelines for workplace drug testing* legal, regulatory aspects and policies for drugs and alcohol* urine and alternative sample collection process* analytical techniques and specimen adulteration.Case studies of successful programmes are also included to illustrate the principles discussed.Written by internationally acknowledged experts this informative book will be essential reading for anyone interested in workplace drug testing or setting up such a system including clinical and forensic toxicologists, occupational health physicians, nurses, human resources, drug counselling and treatment providers, analytical chemists and lawyers.Alain Verstraete is Professor at the Department of Clinical Chemistry, Microbiology and Immunology, Ghent University, Ghent, Belgium and Department Head of the Toxicology Laboratory of the Laboratory of Clinical Biology, Ghent University Hospital, Ghent, Belgium.
Author: Richard O. Lempert
Publisher:
ISBN:
Category : Alcoholism and employment
Languages : en
Pages :
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Book Description
Author: Raphael C. Wong
Publisher: Springer Science & Business Media
ISBN: 1592599516
Category : Medical
Languages : en
Pages : 308
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Book Description
A comprehensive review of the science of drug testing in all its aspects, placing emphasis on technologies that use body fluids other than urine for determining the presence of drugs of abuse. The authors discuss the various body fluid specimens suitable for testing for illicit drugs-particularly saliva, sweat, and hair-describe the structural and manufacturing aspects of on-site testing devices based on lateral flow immunoassay, and detail the pitfalls of using these specimens. They also discuss in detail the problem of sample adulteration and its detection. Since oral fluid has the best potential of succeeding urine as the next matrix of choice for drug detection, four popular saliva testing devices are examined: Intercept®, the Drager Drug Test®, Oratect®, and Drugwipe. Political, social, and legal issues are also considered in articles on privacy, the use of drug testing in courts, and the problem of sample adulteration.
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.
Author:
Publisher:
ISBN:
Category : Drug abuse
Languages : en
Pages : 134
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Book Description
Author: Amanda J. Jenkins
Publisher: Springer Science & Business Media
ISBN:
Category : Business & Economics
Languages : en
Pages : 312
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Book Description
It is at least a decade since scientists turned their imaginations to creating new compact, portable test instruments and self-contained test kits that could be used to analyze urine and saliva for alcohol, drugs, and their metabolites. Although the potential applications for such tests at the site of specimen collection, now called “on-site” or “point-of-care” testing, range far beyond hospital emergency rooms and law enforcement needs, it was catalyzed by the requirements of workplace drug testing and other drugs-of-abuse testing programs. These programs are now a minor national industry in the United States and in some western European countries, and cover populations as diverse as the military, incarcerated criminals, people suspected of driving under the influence of alcohol and other drugs, all athletes from college to professional ranks, and of course the general employed population, which is monitored for illegal drug use and numbers in the millions. It is not surprising, then, that the need for rapid and precise tests, conducted economically by trained professionals, has become a major goal. Current government approved and peer reviewed laboratory methods for urine analysis serve present needs very well and have become remarkably robust over the past twenty years, but the logistics of testing some moving populations, such as the military, the Coast Guard, workers on off-shore oil platforms, and athletes—perhaps the most mobile of these groups—are unacceptably cumbersome.
