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Blinding as a Solution to Bias
What information should jurors have during court proceedings to render a just decision? Should politicians know who is donating money to their campaigns? Will scientists draw biased conclusions about drug efficacy when they know more about the patient or study population? The potential for bias in decision-making by physicians, lawyers, politicians, and scientists has been recognized for hundreds of years and drawn attention from media and scholars seeking to understand the role that conflicts of interests and other psychological processes play. However, commonly proposed solutions to biased decision-making, such as transparency (disclosing conflicts) or exclusion (avoiding conflicts) do not...
Pharmacoepidemiology
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.
The Present Illness
Beyond political posturing and industry quick-fixes, why is the American health care system so difficult to reform? Health care reform efforts are difficult to achieve and have been historically undermined by their narrow scope. In The Present Illness, Martin F. Shapiro, MD, PhD, MPH, weaves together history, sociology, extensive research, and his own experiences as a physician to explore the broad range of afflictions impairing US health care and explains why we won't be able to fix the system without making significant changes across society. With a sharp eye and ready humor, Shapiro dissects the ways all groups participating—clinicians and their organizations, medical schools and their ...
Innovation and Protection
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Exposed
A sharp exposé of the roots of the cost-exposure consensus in American health care that shows how the next wave of reform can secure real access and efficiency. The toxic battle over how to reshape American health care has overshadowed the underlying bipartisan agreement that health insurance coverage should be incomplete. Both Democrats and Republicans expect patients to bear a substantial portion of health care costs through deductibles, copayments, and coinsurance. In theory this strategy empowers patients to make cost-benefit tradeoffs, encourages thrift and efficiency in a system rife with waste, and defends against the moral hazard that can arise from insurance. But in fact, as Christ...
Introduction to Clinical Ethics: Perspectives from a Physician Bioethicist
This textbook offers an introduction to the field of bioethics, specifically from a practicing physician standpoint. It engages a wide range of recent scholarship and emerging research covering many crucial topics in clinical ethics. While there has been increasing attention to the role of bioethics in medicine, the gap between theory and practice still exists, and it continues to impede the dialogue between health care professionals from one side and bioethicists and philosophers of medicine from the other side. This book builds bridges and open channels of connection between different parties in these conversations. It does so from a physician’s practical perspective, engaging recent scholarship and emerging research, to shed light on pivotal ethical dilemmas in contemporary clinical practice.
The Law and Economics of Generic Drug Regulation
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering th...
The Cambridge Handbook of Investment-Driven Intellectual Property
This handbook challenges the conventional wisdom that intellectual property is the law of creativity. Traditionally, IP has been instrumental for protecting creations of the mind, with only inventors of original works enjoying exclusive rights. Related, sui generis, and quasi-IP rights, which protect monetary investments and efforts rather than originality and inventiveness, were considered exceptions to the general principles of IP. But increasingly, IP rights are being granted to safeguard corporate investments. This handbook brings together an international roster of contributors to explore this emerging trend. Why are investments the primary driver of legal protection, and often the main requirement to obtain it? Who benefits from such new forms of protection? What should the scope of these new rights be? And are they desirable in the first place? In doing so, the volume is the first to highlight and systematically critique the move from 'intellectual' to 'investment' property.
Pharmaceutical Freedom
Jessica Flanigan defends patients' rights of self-medication on the grounds that same moral reasons against medical paternalism in clinical contexts are also reasons against paternalistic pharmaceutical policies, including prohibitive approval processes and prescription requirements.
