Download or read book New Drugs written by Lawrence Tim Friedhoff and published by Booksurge Publishing. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success. Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products.
Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Emperor s New Drugs written by Irving Kirsch and published by Basic Books. This book was released on 2010-01-26 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do antidepressants work? Of course—everyone knows it. Like his colleagues, Irving Kirsch, a researcher and clinical psychologist, for years referred patients to psychiatrists to have their depression treated with drugs before deciding to investigate for himself just how effective the drugs actually were. Over the course of the past fifteen years, however, Kirsch's research—a thorough analysis of decades of Food and Drug Administration data—has demonstrated that what everyone knew about antidepressants was wrong. Instead of treating depression with drugs, we've been treating it with suggestion. The Emperor's New Drugs makes an overwhelming case that what had seemed a cornerstone of psychiatric treatment is little more than a faulty consensus. But Kirsch does more than just criticize: he offers a path society can follow so that we stop popping pills and start proper treatment for depression.
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
Download or read book Hypertension and You written by Samuel J. Mann and published by Rowman & Littlefield Publishers. This book was released on 2012-06-16 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many of the nearly 70 million Americans with hypertension (high blood pressure) would like to bring it under control through lifestyle changes such as losing weight, cutting back on salt, exercising, or reducing stress. But, like it or not, most will require medication to get their blood pressure where it needs to be. The good news is that we have many excellent blood pressure medications which, when prescribed wisely, can control hypertension in almost everyone. The bad news is that, despite good intentions, doctors are placing millions of people who have hypertension on medications, drug combinations, or doses that are wrong for them, with staggering consequences that include uncontrolled hypertension, higher risk for stroke and heart attack, avoidable side effects, and billions of wasted health care dollars. Here, Dr. Mann, a nationally recognized hypertension specialist, identifies the drugs most likely to have side effects, and those that can be used in their place. He describes the shortcomings of some of the new drugs, while also introducing readers to some excellent old drugs that are woefully underused as a result of the publicity blitz surrounding the new, expensive ones. He emphasizes the importance of matching the medication and dosage to the individual who will be taking them, and presents the overlooked clues that can tell us who should be on which drug (even an excellent drug can be the wrong one if it is given to the wrong person or in the wrong dose). Hypertension and You is directed at the more than 50 million Americans (including a majority of people over the age of 60) who are taking blood pressure medication. Many patients suspect they might be on the wrong medication, but don’t know enough to be sure. This book shows how medications can be prescribed more wisely to achieve better results and gives patients the knowledge they need to capably discuss their medications with their health care providers. Hypertension and You provides many ideas and approaches that will be new to readers, and also to many physicians, and which no other book offers. It’s the first book to make the case that something is terribly wrong with how doctors are prescribing drugs for this condition. It provides readers with better knowledge of the available medications, empowering them to work with their physician to get onto the medications that are right for them.
Download or read book Phase II Clinical Development of New Drugs written by Naitee Ting and published by Springer. This book was released on 2017-04-08 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Ten Drugs written by Thomas Hager and published by Abrams. This book was released on 2019-03-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: “The stories are skillfully told and entirely entertaining . . . An expert, mostly feel-good book about modern medicine” from the award-winning author (Kirkus Reviews, starred review). Behind every landmark drug is a story. It could be an oddball researcher’s genius insight, a catalyzing moment in geopolitical history, a new breakthrough technology, or an unexpected but welcome side effect discovered during clinical trials. Piece together these stories, as Thomas Hager does in this remarkable, century-spanning history, and you can trace the evolution of our culture and the practice of medicine. Beginning with opium, the “joy plant,” which has been used for 10,000 years, Hager tells a captivating story of medicine. His subjects include the largely forgotten female pioneer who introduced smallpox inoculation to Britain, the infamous knockout drops, the first antibiotic, which saved countless lives, the first antipsychotic, which helped empty public mental hospitals, Viagra, statins, and the new frontier of monoclonal antibodies. This is a deep, wide-ranging, and wildly entertaining book. “[An] absorbing new book.” —The New York Times Book Review “[A] well-written and engaging chronicle.” —The Wall Street Journal “Lucidly informative and compulsively readable.” —Publishers Weekly “Entertaining [and] insightful.” —Booklist “Well-written, well-researched and fascinating to read Ten Drugs provides an insightful look at how drugs have shaped modern medical practices. Towards the end of the book Hager writes that he ‘came away surprised by some of the things he had learned.’ I had the very same reaction.” —Penny Le Couteur, coauthor of Napoleon’s Buttons: How 17 Molecules Changed History
Download or read book The 800 Million Pill written by Merrill Goozner and published by Univ of California Press. This book was released on 2005-10-10 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Goozner shows how drug innovation is driven by dedicated scientists intent on finding cures for diseases, not by pharmaceutical firms, whose bottom line often takes precedence over the advance of medicine. Stories of a university biochemist who spent twenty years searching for single blood protein that later became the best-selling biotech drug in the world, a government employee who discovered the causes for dozens of crippling genetic disorders, and the Department of Energy-funded research that made the Human Genome Project possible - these accounts illustrate how medical breakthroughs actually take place.".
Download or read book The Risks of Prescription Drugs written by Donald Light and published by Columbia University Press. This book was released on 2010 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Few people realize that prescription drugs have become a leading cause of death, disease, and disability. Adverse reactions to widely used drugs, such as psychotropics and birth control pills, as well as biologicals, result in FDA warnings against adverse reactions. The Risks of Prescription Drugs describes how most drugs approved by the FDA are under-tested for adverse drug reactions, yet offer few new benefits. Drugs cause more than 2.2 million hospitalizations and 110,000 hospital-based deaths a year. Serious drug reactions at home or in nursing homes would significantly raise the total. Women, older people, and people with disabilities are least used in clinical trials and most affected. Health policy experts Donald Light, Howard Brody, Peter Conrad, Allan Horwitz, and Cheryl Stults describe how current regulations reward drug companies to expand clinical risks and create new diseases so millions of patients are exposed to unnecessary risks, especially women and the elderly. They reward developing marginally better drugs rather than discovering breakthrough, life-saving drugs. The Risks of Prescription Drugs tackles critical questions about the pharmaceutical industry and the privatization of risk. To what extent does the FDA protect the public from serious side effects and disasters? What is the effect of giving the private sector and markets a greater role and reducing public oversight? This volume considers whether current rules and incentives put patients' health at greater risk, the effect of the expansion of disease categories, the industry's justification of high U.S. prices, and the underlying shifts in the burden of risk borne by individuals in the world of pharmaceuticals. Chapters cover risks of statins for high cholesterol, SSRI drugs for depression and anxiety, and hormone replacement therapy for menopause. A final chapter outlines six changes to make drugs safer and more effective. Suitable for courses on health and aging, gender, disability, and minority studies, this book identifies the Risk Proliferation Syndrome that maximizes the number of people exposed to these risks. Additional Columbia / SSRC books on the privatization of risk and its implications for Americans: Bailouts: Public Money, Private ProfitEdited by Robert E. Wright Disaster and the Politics of InterventionEdited by Andrew Lakoff Health at Risk: America's Ailing Health System-and How to Heal ItEdited by Jacob S. Hacker Laid Off, Laid Low: Political and Economic Consequences of Employment InsecurityEdited by Katherine S. Newman Pensions, Social Security, and the Privatization of RiskEdited by Mitchell A. Orenstein
Download or read book The Selection and Use of Essential Medicines written by WHO Expert Committee on the Selection and Use of Essential Medicines and published by WHO. This book was released on 2004 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.
Download or read book FDA in the Twenty First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Download or read book Drugs and Drug Policy written by Mark A.R. Kleiman and published by Oxford University Press. This book was released on 2011-07-13 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Nursing2022 Drug Handbook written by Lippincott Williams & Wilkins and published by Lippincott Williams & Wilkins. This book was released on 2021-03-04 with total page 2933 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE #1 Drug Guide for nurses & other clinicians...always dependable, always up to date! Look for these outstanding features: Completely updated nursing-focused drug monographs featuring 3,500 generic, brand-name, and combination drugs in an easy A-to-Z format NEW 32 brand-new FDA-approved drugs in this edition, including the COVID-19 drug remdesivir—tabbed and conveniently grouped in a handy “NEW DRUGS” section for easy retrieval NEW Thousands of clinical updates—new dosages and indications, Black Box warnings, genetic-related information, adverse reactions, nursing considerations, clinical alerts, and patient teaching information Special focus on U.S. and Canadian drug safety issues and concerns Photoguide insert with images of 439 commonly prescribed tablets and capsules
Download or read book Drugs for Life written by Joseph Dumit and published by Duke University Press. This book was released on 2012-09-03 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Challenges our understanding of health, risks, facts, and clinical trials [Payot]
Download or read book Drug Use for Grown Ups written by Dr. Carl L. Hart and published by Penguin. This book was released on 2022-01-11 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Hart’s argument that we need to drastically revise our current view of illegal drugs is both powerful and timely . . . when it comes to the legacy of this country’s war on drugs, we should all share his outrage.” —The New York Times Book Review From one of the world's foremost experts on the subject, a powerful argument that the greatest damage from drugs flows from their being illegal, and a hopeful reckoning with the possibility of their use as part of a responsible and happy life Dr. Carl L. Hart, Ziff Professor at Columbia University and former chair of the Department of Psychology, is one of the world's preeminent experts on the effects of so-called recreational drugs on the human mind and body. Dr. Hart is open about the fact that he uses drugs himself, in a happy balance with the rest of his full and productive life as a researcher and professor, husband, father, and friend. In Drug Use for Grown-Ups, he draws on decades of research and his own personal experience to argue definitively that the criminalization and demonization of drug use--not drugs themselves--have been a tremendous scourge on America, not least in reinforcing this country's enduring structural racism. Dr. Hart did not always have this view. He came of age in one of Miami's most troubled neighborhoods at a time when many ills were being laid at the door of crack cocaine. His initial work as a researcher was aimed at proving that drug use caused bad outcomes. But one problem kept cropping up: the evidence from his research did not support his hypothesis. From inside the massively well-funded research arm of the American war on drugs, he saw how the facts did not support the ideology. The truth was dismissed and distorted in order to keep fear and outrage stoked, the funds rolling in, and Black and brown bodies behind bars. Drug Use for Grown-Ups will be controversial, to be sure: the propaganda war, Dr. Hart argues, has been tremendously effective. Imagine if the only subject of any discussion about driving automobiles was fatal car crashes. Drug Use for Grown-Ups offers a radically different vision: when used responsibly, drugs can enrich and enhance our lives. We have a long way to go, but the vital conversation this book will generate is an extraordinarily important step.
Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 1984 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
