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Author :
Publisher :
ISBN 13 :
Total Pages : 144 pages
Book Rating : 4.3/5 (91 download)
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:
Author : National Academy of Sciences/Smithsonian Institution
Publisher : National Academies Press
ISBN 13 : 0309037395
Total Pages : 535 pages
Book Rating : 4.3/5 (9 download)
Download or read book Biodiversity written by National Academy of Sciences/Smithsonian Institution and published by National Academies Press. This book was released on 1988-01-01 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This important book for scientists and nonscientists alike calls attention to a most urgent global problem: the rapidly accelerating loss of plant and animal species to increasing human population pressure and the demands of economic development. Based on a major conference sponsored by the National Academy of Sciences and the Smithsonian Institution, Biodiversity creates a systematic framework for analyzing the problem and searching for possible solutions.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)
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.
Author : WHO Expert Committee on the Selection and Use of Essential Medicines
Publisher : WHO
ISBN 13 :
Total Pages : 144 pages
Book Rating : 4.3/5 ( download)
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.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309486483
Total Pages : 175 pages
Book Rating : 4.3/5 (94 download)
Download or read book Medications for Opioid Use Disorder Save Lives written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-06-16 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already existâ€"like evidence-based medicationsâ€"are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Daniel E. Harmon
Publisher : The Rosen Publishing Group, Inc
ISBN 13 : 1435850262
Total Pages : 66 pages
Book Rating : 4.4/5 (358 download)
Download or read book New Medicines written by Daniel E. Harmon and published by The Rosen Publishing Group, Inc. This book was released on 2009-01-15 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discusses the history of medical research and the ethical issues surrounding the Food and Drug Administration's regulation of the testing, marketing, and sale of drugs in the United States.
Author : Bernice Z. Schacter
Publisher : Bloomsbury Publishing USA
ISBN 13 : 0313083258
Total Pages : 281 pages
Book Rating : 4.3/5 (13 download)
Download or read book The New Medicines written by Bernice Z. Schacter and published by Bloomsbury Publishing USA. This book was released on 2005-12-30 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented? How do consumers know that drugs are safe and effective? How are they tested? Who regulates their production - and who watches the regulators? How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do? The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold. In addition to explaining how drugs reach the medicine cabinet, the author - an experienced researcher and teacher - provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as: The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated. The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal. The strengths and weaknesses of the approval process of the Food and Drug Administration. The controversial new marketing techniques of the pharmaceutical industry. A balanced work that provides readers with an unbiased look at the drug industry, The New Medicines will answer the questions of anyone who has ever looked at a bottle of their prescription pills and wondered, how did that get here?
Author : Donald R. Kirsch
Publisher : Simon and Schuster
ISBN 13 : 1628727195
Total Pages : 298 pages
Book Rating : 4.6/5 (287 download)
Download or read book The Drug Hunters written by Donald R. Kirsch and published by Simon and Schuster. This book was released on 2016-12-13 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: The surprising, behind-the-scenes story of how our medicines are discovered, told by a veteran drug hunter. The search to find medicines is as old as disease, which is to say as old as the human race. Through serendipity— by chewing, brewing, and snorting—some Neolithic souls discovered opium, alcohol, snakeroot, juniper, frankincense, and other helpful substances. Ötzi the Iceman, the five-thousand-year-old hunter frozen in the Italian Alps, was found to have whipworms in his intestines and Bronze-age medicine, a worm-killing birch fungus, knotted to his leggings. Nowadays, Big Pharma conglomerates spend billions of dollars on state-of the art laboratories staffed by PhDs to discover blockbuster drugs. Yet, despite our best efforts to engineer cures, luck, trial-and-error, risk, and ingenuity are still fundamental to medical discovery. The Drug Hunters is a colorful, fact-filled narrative history of the search for new medicines from our Neolithic forebears to the professionals of today, and from quinine and aspirin to Viagra, Prozac, and Lipitor. The chapters offer a lively tour of how new drugs are actually found, the discovery strategies, the mistakes, and the rare successes. Dr. Donald R. Kirsch infuses the book with his own expertise and experiences from thirty-five years of drug hunting, whether searching for life-saving molecules in mudflats by Chesapeake Bay or as a chief science officer and research group leader at major pharmaceutical companies.
Author : J. Rick Turner
Publisher : Springer Science & Business Media
ISBN 13 : 1441964185
Total Pages : 269 pages
Book Rating : 4.4/5 (419 download)
Download or read book New Drug Development written by J. Rick Turner and published by Springer Science & Business Media. This book was released on 2010-07-16 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.
Author : Katherine Eban
Publisher : HarperCollins
ISBN 13 : 0063054108
Total Pages : 523 pages
Book Rating : 4.0/5 (63 download)
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 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a 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.
Author : Merrill Goozner
Publisher : Univ of California Press
ISBN 13 : 9780520246706
Total Pages : 308 pages
Book Rating : 4.2/5 (467 download)
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.".
Author :
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.3/5 (91 download)
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1981 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Author : Holly Fernandez Lynch
Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.2/5 (315 download)
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.
Author : Mark J. Plotkin
Publisher : Penguin
ISBN 13 : 014012991X
Total Pages : 353 pages
Book Rating : 4.1/5 (41 download)
Download or read book Tales of a Shaman's Apprentice written by Mark J. Plotkin and published by Penguin. This book was released on 1994-08-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fascinating account of a pioneering ethnobotanist’s travels in the Amazon—at once a gripping adventure story, a passionate argument for conservationism, and an investigation into the healing power of plants, by the author of The Amazon: What Everyone Needs to Know For thousands of years, healers have used plants to cure illness. Aspirin, the world's most widely used drug, is based on compounds originally extracted from the bark of a willow tree, and more than a quarter of medicines found on pharmacy shelves contain plant compounds. Now Western medicine, faced with health crises such as AIDS, Alzheimer's disease, and cancer, has begun to look to the healing plants used by indigenous peoples to develop powerful new medicines. Nowhere is the search more promising than in the Amazon, the world's largest tropical forest, home to a quarter of all botanical species on this planet—as well as hundreds of Indian tribes whose medicinal plants have never been studied by Western scientists. In Tales of a Shaman's Apprentice, ethnobotanist Mark J. Plotkin recounts his travels and studies with some of the most powerful Amazonian shamans, who taught him the plant lore their tribes have spent thousands of years gleaning from the rain forest. For more than a decade, Dr. Plotkin raced against time to harvest and record new plants before the rain forests' fragile ecosystems succumb to overdevelopment—and before the Indians abandon their own culture and learning for the seductive appeal of Western material culture. Tales of a Shaman's Apprentice relates nine of the author's quests, taking the reader along on a wild odyssey as he participates in healing rituals; discovers the secret of curare, the lethal arrow poison that kills in minutes; tries the hallucinogenic snuff epena that enables the Indians to speak with their spirit world; and earns the respect and fellowship of the mysterious shamans as he proves that he shares both their endurance and their reverence for the rain forest.
