New Drugs

Author : Lawrence Tim Friedhoff
Publisher : Booksurge Publishing
Page : 0 pages
File Size : 51,7 Mb
Release : 2009
Category : Drug development
ISBN : 141969961X

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New Drugs by Lawrence Tim Friedhoff Pdf

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.

Author : Irving Kirsch
Publisher : Random House
Page : 240 pages
File Size : 53,8 Mb
Release : 2009-10-13
Category : Business & Economics
ISBN : 9781409086352

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The Emperor's New Drugs by Irving Kirsch Pdf

Everyone knows that antidepressant drugs are miracles of modern medicine. Professor Irving Kirsch knew this as well as anyone. But, as he discovered during his research, there is a problem with what everyone knows about antidepressant drugs. It isn't true. How did antidepressant drugs gain their reputation as a magic bullet for depression? And why has it taken so long for the story to become public? Answering these questions takes us to the point where the lines between clinical research and marketing disappear altogether. Using the Freedom of Information Act, Kirsch accessed clinical trials that were withheld, by drug companies, from the public and from the doctors who prescribe antidepressants. What he found, and what he documents here, promises to bring revolutionary change to the way our society perceives, and consumes, antidepressants. The Emperor's New Drugs exposes what we have failed to see before: depression is not caused by a chemical imbalance in the brain; antidepressants are significantly more dangerous than other forms of treatment and are only marginally more effective than placebos; and, there are other ways to combat depression, treatments that don't only include the empty promise of the antidepressant prescription. This is not a book about alternative medicine and its outlandish claims. This is a book about fantasy and wishful thinking in the heart of clinical medicine, about the seductions of myth, and the final stubbornness of facts.

Author : Anonim
Publisher : Unknown
Page : 144 pages
File Size : 46,6 Mb
Release : 1998
Category : Veterinary drugs
ISBN : UOM:39015035689275

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FDA Approved Animal Drug Products by Anonim Pdf

Author : Naitee Ting,Ding-Geng Chen,Shuyen Ho,Joseph C. Cappelleri
Publisher : Springer
Page : 241 pages
File Size : 47,5 Mb
Release : 2017-04-08
Category : Medical
ISBN : 9789811041945

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Phase II Clinical Development of New Drugs by Naitee Ting,Ding-Geng Chen,Shuyen Ho,Joseph C. Cappelleri Pdf

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.

Author : Katherine Eban
Publisher : HarperCollins
Page : 512 pages
File Size : 40,9 Mb
Release : 2020-06-23
Category : Medical
ISBN : 9780063054103

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Bottle of Lies by Katherine Eban Pdf

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.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 44,5 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060

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Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf

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
Page : 144 pages
File Size : 50,5 Mb
Release : 2004
Category : Medical
ISBN : IND:30000093001240

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The Selection and Use of Essential Medicines by WHO Expert Committee on the Selection and Use of Essential Medicines Pdf

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 : Mohd Sajjad Ahmad Khan,Iqbal Ahmad,Debprasad Chattopadhyay
Publisher : Academic Press
Page : 710 pages
File Size : 44,5 Mb
Release : 2018-10-23
Category : Medical
ISBN : 9780128146200

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New Look to Phytomedicine by Mohd Sajjad Ahmad Khan,Iqbal Ahmad,Debprasad Chattopadhyay Pdf

New Look to Phytomedicine: Advancements in Herbal Products as Novel Drug Leads is a compilation of in-depth information on the phytopharmaceuticals used in modern medicine for the cure and management of difficult-to-treat and challenging diseases. Readers will find cutting-edge knowledge on the use of plant products with scientific validation, along with updates on advanced herbal medicine in pharmacokinetics and drug delivery. This authoritative book is a comprehensive collection of research based, scientific validations of bioactivities of plant products, such as anti-infective, anti-diabetic, anti-cancer, immune-modulatory and metabolic disorders presented by experts from across the globe. Step-by-step information is presented on chemistry, bioactivity and the functional aspects of biologically active compounds. In addition, the pharmacognosy of plant products with mechanistic descriptions of their actions, including pathogenicity is updated with information on the use of nanotechnology and molecular tools in relation to herbal drug research. Compiles up-to-date information on the chemotherapeutics used in the treatment of infective and metabolic disorders Presents advancements in the discovery of new drugs from plants using molecular and nanotechnology tools Examines detailed information on the use of herbals agents in cancer, HIV and other ailments, including diabetes, malaria and neurological disorders

Author : Samuel J. Mann
Publisher : Rowman & Littlefield Publishers
Page : 204 pages
File Size : 42,9 Mb
Release : 2012-06-16
Category : Health & Fitness
ISBN : 9781442215191

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Hypertension and You by Samuel J. Mann Pdf

Most of the 75 million Americans who have high blood pressure need medication to control it, but many are prescribed medication that is wrong for them. Dr. Mann reveals how readers, with the oversight of their physician, can get off the wrong medications and onto the right ones to achieve a healthy blood pressure without side effects.

Author : T.T. Hansel,P.J. Barnes
Publisher : Karger Medical and Scientific Publishers
Page : 324 pages
File Size : 48,7 Mb
Release : 2010-08-31
Category : Medical
ISBN : 9783805595674

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New Drugs and Targets for Asthma and COPD by T.T. Hansel,P.J. Barnes Pdf

Asthma, allergy and chronic obstructive lung disease are common throughout the world and are increasing in incidence, particularly in the developing world. This volume provides a state-of-the-art account of the identification of new targets and the development of new therapies for these conditions. Some 40 chapters by clinical academics and senior members of the pharmaceutical industry detail the latest breakthroughs in research and development. In asthma, a promising approach is the use of therapy directed against specific Th2 responses through biological antagonists of IL-5, IL-4 and IL-13. There have also been major advances in our understanding of innate immune responses to pathogen-associated molecular patterns, and in the area of Toll-like receptors. Up to date and comprehensive, this book will be of particular relevance to those working in the pharmaceutical industry (in preclinical research and clinical development), to academic researchers in the field of respiratory medicine, and to respiratory health care specialists.

Author : Merrill Goozner
Publisher : Univ of California Press
Page : 308 pages
File Size : 46,5 Mb
Release : 2005-10-10
Category : Medical
ISBN : 0520246705

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The $800 Million Pill by Merrill Goozner Pdf

"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 : Donald Light
Publisher : Columbia University Press
Page : 179 pages
File Size : 44,8 Mb
Release : 2010
Category : Business & Economics
ISBN : 9780231146920

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The Risks of Prescription Drugs by Donald Light Pdf

Raises key questions about topics in the pharmaceutical industry, including how the risks of side effects are weighed, if privatization of that risk is prudent, and the high prices for drugs.

Author : Phuc Van Pham
Publisher : Springer
Page : 157 pages
File Size : 42,6 Mb
Release : 2018-10-25
Category : Science
ISBN : 9783319993287

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Stem Cell Drugs - A New Generation of Biopharmaceuticals by Phuc Van Pham Pdf

This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products. Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.

Author : Sean C. Sweetman
Publisher : Unknown
Page : 3335 pages
File Size : 42,6 Mb
Release : 2006-01-01
Category : Medical
ISBN : 0853697043

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Martindale by Sean C. Sweetman Pdf

This is thirty-fifth edition of Martindale, which provides reliable, and evaluated information on drugs and medicines used throughout the world. It contains encyclopaedic facts about drugs and medicines, with: 5,500 drug monographs; 128,000 preparations; 40,700 reference citations; 10,900 manufacturers. There are synopses of disease treatments which enables identification of medicines, the local equivalent and the manufacturer. It also Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines. Based on published information and extensively referenced

Author : Anonim
Publisher : Elsevier
Page : 592 pages
File Size : 50,5 Mb
Release : 2020-11-04
Category : Medical
ISBN : 9780128203293

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Side Effects of Drugs Annual by Anonim Pdf

Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 42, first published in 1977, and continually published as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs, presents clinicians and medical investigators with a critical survey of new data and trends in adverse drug reactions and interactions. Topics covered in this new release include Central Nervous System Stimulants and Drugs that Suppress Appetite, Antidepressants, Lithium, Drugs of Abuse, Hypnotics and Sedatives, Antipsychotic Drugs, Antiepileptics, Opioid Analgesics and Narcotic Antagonists, Anti-Inflammatory and Antipyretic Analgesics and Drugs Used in Gout, and much more. Provides a critical yearly survey of the new data and trends regarding the side effects of drugs Authored and reviewed by worldwide pioneers in the clinical and practice sciences Presents an essential clinical guide on the side effects of drugs for practitioners and healthcare professionals alike