Pharmacopolitics PDF Download

Author: Arthur A. Daemmrich
Publisher: Chemical Heritage Foundation
ISBN: 9780807828441
Category : Law
Languages : en
Pages : 232

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Book Description
Pharmacopolitics: Drug Regulation in the United States and Germany

Author: Bert Spilker
Publisher: Lippincott Williams & Wilkins
ISBN:
Category : Business & Economics
Languages : en
Pages : 856

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Book Description

Author: Kai Purnhagen
Publisher: Springer Science & Business Media
ISBN: 9400765436
Category : Law
Languages : en
Pages : 452

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Book Description
This book examines the increasing role of the legal method of systematisation in European Union (EU) law. It argues that the legal method of systematisation that has been developed in a welfare-state context is increasingly used as a regulative tool to functionally integrate the market. The book uses the example of EU product regulation as a reference to illustrate the impact of systematisation on EU law. It draws conclusions from this phenomenon and redefines the current place and origin of systematisation in the EU legal system. It puts forward and demonstrates two main arguments. First, in certain sectors such as in EU product safety law, the quality of EU law changes from a sector-specific and reactive field of law to an increasingly coherent legal system at European level. Therefore, instead of punctual market intervention, it increasingly governs whole market areas. By doing so, it challenges and often fully replaces the respective welfare-based legal systems in the Member States for the benefit of the ideal of a market-driven EU legal system. Second, at European level, the ideal is in development. This illustrates the change of the function of Statecraft from nation-states to market-states.​

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309218136
Category : Medical
Languages : en
Pages : 292

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Book Description
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220

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Book Description
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

Author: Markus Müller
Publisher: Springer
ISBN: 3319273477
Category : Medical
Languages : en
Pages : 398

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Book Description
This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.

Author: Sergio Sismondo
Publisher:
ISBN: 9780995527782
Category : Drugs
Languages : en
Pages : 231

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Book Description

Author: Nancy Tomes
Publisher: UNC Press Books
ISBN: 1469622785
Category : Medical
Languages : en
Pages : 560

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Book Description
In a work that spans the twentieth century, Nancy Tomes questions the popular--and largely unexamined--idea that in order to get good health care, people must learn to shop for it. Remaking the American Patient explores the consequences of the consumer economy and American medicine having come of age at exactly the same time. Tracing the robust development of advertising, marketing, and public relations within the medical profession and the vast realm we now think of as "health care," Tomes considers what it means to be a "good" patient. As she shows, this history of the coevolution of medicine and consumer culture tells us much about our current predicament over health care in the United States. Understanding where the shopping model came from, why it was so long resisted in medicine, and why it finally triumphed in the late twentieth century helps explain why, despite striking changes that seem to empower patients, so many Americans remain unhappy and confused about their status as patients today.

Author: Gerald Posner
Publisher: Simon and Schuster
ISBN: 1501152033
Category : Business & Economics
Languages : en
Pages : 816

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Book Description
"Exorbitant prices for lifesaving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in pharmaceutical companies. Now, Americans are demanding national reckoning with a monolithic industry. In Pharma, award-winning journalist and New York Times best-selling author Gerald Posner uncovers the real story of the Sacklers, the family that became one of America's wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the centure of the opioid crisis. The unexpected twists and turns of the Sakler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. Pharma reveals how and why American drug companies have put earnings ahead of patients"--

Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 0470654759
Category : Medical
Languages : en
Pages : 977

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Book Description
Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.