Red Book

Red Book

Author: Thomson

Publisher: Wiley-Blackwell

Published: 2008

Total Pages: 0

ISBN-13: 9781563636714

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The new "2008 Red Book" not only presents the latest pricing and product information on more than 160,000 prescription and over-the-counter items, but also a complete list of newly FDA-approved brands, generics, and biologics.


Statistical Issues in Drug Development

Statistical Issues in Drug Development

Author: Stephen S. Senn

Publisher: John Wiley & Sons

Published: 2008-02-28

Total Pages: 523

ISBN-13: 9780470723579

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Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.


Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-09-28

Total Pages: 483

ISBN-13: 0309459575

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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.


Drugs and Drug Policy

Drugs and Drug Policy

Author: Mark A.R. Kleiman

Publisher: Oxford University Press

Published: 2011-07-13

Total Pages: 258

ISBN-13: 0199831386

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While there have always been norms and customs around the use of drugs, explicit public policies--regulations, taxes, and prohibitions--designed to control drug abuse are a more recent phenomenon. Those policies sometimes have terrible side-effects: most prominently the development of criminal enterprises dealing in forbidden (or untaxed) drugs and the use of the profits of drug-dealing to finance insurgency and terrorism. Neither a drug-free world nor a world of free drugs seems to be on offer, leaving citizens and officials to face the age-old problem: What are we going to do about drugs? In Drugs and Drug Policy, three noted authorities survey the subject with exceptional clarity, in this addition to the acclaimed series, What Everyone Needs to Know®. They begin, by defining "drugs," examining how they work in the brain, discussing the nature of addiction, and exploring the damage they do to users. The book moves on to policy, answering questions about legalization, the role of criminal prohibitions, and the relative legal tolerance for alcohol and tobacco. The authors then dissect the illicit trade, from street dealers to the flow of money to the effect of catching kingpins, and show the precise nature of the relationship between drugs and crime. They examine treatment, both its effectiveness and the role of public policy, and discuss the beneficial effects of some abusable substances. Finally they move outward to look at the role of drugs in our foreign policy, their relationship to terrorism, and the ugly politics that surround the issue. Crisp, clear, and comprehensive, this is a handy and up-to-date overview of one of the most pressing topics in today's world. What Everyone Needs to Know® is a registered trademark of Oxford University Press.


Drug Delivery

Drug Delivery

Author: W. Mark Saltzman

Publisher: Oxford University Press

Published: 2001-03-15

Total Pages: 385

ISBN-13: 0199879753

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Synthetic materials are a tremendous potential resource for treating human disease. For the rational design of many of these biomaterials it is necessary to have an understanding of polymer chemistry and polymer physics. Equally important to those two fields is a quantitative understanding of the principles that govern rates of drug transport, reaction, and disappearance in physiological and pathological situations. This book is a synthesis of these principles, providing a working foundation for those in the field of drug delivery. It covers advanced drug delivery and contemporary biomaterials.


The Cannabis Social Club

The Cannabis Social Club

Author: Mafalda Pardal

Publisher: Taylor & Francis

Published: 2022-07-29

Total Pages: 223

ISBN-13: 1000620344

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As cannabis legalization reforms are underway, there is some concern that non-profit, ‘middle ground’ options may remain under-researched and thus less visible. This book offers an in-depth account of one of the possible ‘middle ground’ models for the supply of cannabis: the Cannabis Social Club. Cannabis Social Clubs (CSCs) are typically formal, non-profit associations of adult cannabis users who produce and distribute that substance close to or at cost price among themselves. They constitute an user-driven model for the supply of cannabis. In most jurisdictions, CSCs remain a grass roots, unregulated initiative of groups of users, but the model has been legalized in Uruguay and Malta, and it has featured recent debates and legislative proposals in other countries. This book brings together contributions from internationally respected scholars, drawing on case studies, empirical findings and policy reflections, from a range of countries (such as Belgium, Canada, New Zealand, Spain, Uruguay, USA), and a consideration of the CSC model from different disciplinary backgrounds. Part one provides detailed analysis of where and how CSCs have been operating, and a critical analysis of their key features and relationship with institutional actors. Part two discusses several policy outcomes and proposes a design of a regulatory market, as well as considering whether the CSC model might be suited for adaptation to the supply of other substances. The Cannabis Social Club is important reading for academics in the fields of drug policy analysis, criminology, economics, policy studies and anthropology. It will also be of interest to policy makers, journalists, law-enforcement personnel.