the new medicines how drugs are created approved marketed and sold

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The New Medicines

Author : Bernice Zeldin Schacter
ISBN : 027598141X
Genre : Health & Fitness
File Size : 66. 9 MB
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Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc.

Marijuana As Medicine

Author : Alison Mack
ISBN : 9780309065313
Genre : Medical
File Size : 66. 41 MB
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Some people suffer from chronic, debilitating disorders for which no conventional treatment brings relief. Can marijuana ease their symptoms? Would it be breaking the law to turn to marijuana as a medication? There are few sources of objective, scientifically sound advice for people in this situation. Most books about marijuana and medicine attempt to promote the views of advocates or opponents. To fill the gap between these extremes, authors Alison Mack and Janet Joy have extracted critical findings from a recent Institute of Medicine study on this important issue, interpreting them for a general audience. Marijuana As Medicine? provides patients--as well as the people who care for them--with a foundation for making decisions about their own health care. This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. The dangers of smoking marijuana, as well as the effects of its active chemical components on the immune system and on psychological health. The potential use of marijuana-based medications on symptoms of AIDS, cancer, multiple sclerosis, and several other specific disorders, in comparison with existing treatments. Marijuana As Medicine? introduces readers to the active compounds in marijuana. These include the principal ingredient in Marinol, a legal medication. The authors also discuss the prospects for developing other drugs derived from marijuana's active ingredients. In addition to providing an up-to-date review of the science behind the medical marijuana debate, Mack and Joy also answer common questions about the legal status of marijuana, explaining the conflict between state and federal law regarding its medical use. Intended primarily as an aid to patients and caregivers, this book objectively presents critical information so that it can be used to make responsible health care decisions. Marijuana As Medicine? will also be a valuable resource for policymakers, health care providers, patient counselors, medical faculty and students--in short, anyone who wants to learn more about this important issue.

Making Cancer History

Author : James S. Olson
ISBN : STANFORD:36105124191763
Genre : Medical
File Size : 42. 28 MB
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The history of the M. D. Anderson Cancer Center vividly reveals how cancer treatment in America -- and our attitudes toward the disease -- has changed since the middle of the twentieth century. One of the preeminent cancer centers in the world, M. D. Anderson is also one of the first medical institutions devoted exclusively to caring for people with cancer and researching treatments and cures for the disease. Historian James S. Olson's narrative relates the story of the center's founding and of the surgeons, radiologists, radiotherapists, nurses, medical oncologists, scientists, administrators, and patients who built M. D. Anderson into the world-class institution it is today. Through interviews with M. D. Anderson's leaders and patients, Olson brings to life the struggle to understand and treat cancer in America. A cancer survivor who has himself been treated at the center, Olson imbues this history with humor, passion, and humanity. -- Helen Valier

Reasonable Rx

Author : Stan Finkelstein
ISBN : 0132703998
Genre : Business & Economics
File Size : 76. 63 MB
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A Real Plan for Making Drugs Affordable–and Promoting Innovation, Too “This book is a necessity for understanding the pharmaceutical industry. Both the pluses and minuses of the present system are set forth with a judicious combination of historical narrative, economic analysis, and statistical data. The highly original proposals for reform will be a major stimulant to analysis and policy-making.” –Kenneth Arrow, Nobel Laureate in Economics, Professor Emeritus, Stanford University “This is a timely book by authors who know what they are talking about. They tackle a big problem: rising drug prices that are threatening to overwhelm us all–and especially those with limited or absent health care insurance. Will we drive people overseas for healthcare? Will there be social unrest? This book describes the problem and then offers a solution. Worth a careful read by everyone, pharmaceutical manufacturers and government policymakers especially.” –Roger Williams, M.D., Chief Executive Officer of the United States Pharmacopeia and a former senior official of the Food and Drug Administration “This book confounds two sets of skeptics: Those who say there’s no way to resolve the conflict between the need to fund pharmaceutical research and our desire to keep medicine affordable; and those who think that economics never has anything good to say.” –Honorable Barney Frank, Congressman from Massachusetts “This book comes at the right time and could become the starting point of discussions, which will eventually lead us into new era in the healthcare care industry. It will without a doubt become a must for insiders of the pharma- and biotech industries.” –Dr. Jürgen Drews, retired President of Roche Pharmaceutical Group Global Research Acknowledgments viii About the Authors ix Introduction xi Chapter 1: Drugs and Drug Prices 1 Chapter 2: The American Way to Discover Drugs 21 Chapter 3: The Drug Industry Today 39 Chapter 4: Are Drug Companies Risky? 59 Chapter 5: How Not to Lower Drug Prices 77 Chapter 6: Squandering R & D Resources 103 Chapter 7: How to Lower Drug Prices 129 Appendix: Our Solution in Detail 155 Index 177

Access To Medicine In The Global Economy

Author : Cynthia Ho
ISBN : 9780199750184
Genre : Law
File Size : 26. 23 MB
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Access to medicine is a topic of widespread interest. However, some issues that impact such access are presently inadequately understood. In particular, international laws require most nations to provide patents on drugs, resulting in premium prices that limit access. In Access to Medicine in the Global Economy, Professor Cynthia Ho explains such laws and their impact for a diverse group of readers, from scholars and policy makers to students in a variety of disciplines. This book explains and interprets important international agreements, beginning with the landmark Agreement on Trade Related Aspects of Intellectual Property (TRIPS), but also including more recent free trade agreements and the pending Anti-Counterfeiting Trade Agreement (ACTA). Professor Ho addresses controversial topics, such as when a nation can provide a compulsory license, as well as whether a nation may suspend in-transit generic goods. The book also discusses how patent-like rights (such as "data exclusivity") prevent lower-cost generic medicines from entering into the marketplace and provides strategies for minimizing the harm of such rights. Clear explanations and diagrams, frequently asked questions, and case studies make these topics accessible to any reader. The case studies also provide a theory of patent perspectives that helps explain why access to medicine, though a universal goal, remains elusive in practice. The book aims to provide an important first step toward eventual workable solutions by promoting a better understanding of existing and future laws that impact access to medicine.

New Drug Approval Process Fifth Edition

Author : Richard A. Guarino
ISBN : 1420088491
Genre : Medical
File Size : 26. 66 MB
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The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed. Updated chapters include: advances in international regulatory requirements, including ICH guidelines and harmonization a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

Congressional Record V 153 Pt 2 January 18 2007 To February 1 2007

Author : U S Congress
ISBN : 0160868254
Genre : Political Science
File Size : 67. 71 MB
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Effective Drug Regulation

Author : Ratanawijitrasin S
ISBN : 9789241562065
Genre : Medical
File Size : 29. 9 MB
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Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.

Advanced Emergency Care And Transportation Of The Sick And Injured

Author : American Academy of Orthopaedic Surgeons (AAOS),
ISBN : 9781449684280
Genre : Medical
File Size : 28. 7 MB
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Based on the new National EMS Education Standards for Advanced Emergency Medical Technician, the Second Edition offers complete coverage of every competency statement with clarity and precision in a concise format that ensures student comprehension and encourages critical thinking. New cognitive and didactic material is presented, along with new skills and features, to create an innovative AEMT training solution. Topics including advanced pathophysiology, acid-base balance, fluids and electrolytes, intravenous therapy, intraosseous access, blood glucose monitoring, and administration of AEMT-level medications tailor this textbook to the new Advanced EMT level. Important Notice: The digital edition of this book is missing some of the images or content found in the physical edition.

Countering The Problem Of Falsified And Substandard Drugs

Author : Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
ISBN : 9780309269391
Genre : Medical
File Size : 82. 25 MB
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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

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