Bottle of Lies: The Inside Story of the Generic Drug
A NEW YORK TIMES BESTSELLER 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 pharmaceuticalsMany 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 ...
- ASIN: 0062338781
Pocket Guide for Brand and Generic
Pocket Guide for Brand and Generic Drugs contains an alphabetical list of brand name drugs and their generic name. This handy pocket-size guide is an excellent resource for use in the classroom to accompany additional educational products, and as an on-the-job reference. Pocket Guide for Brand and Generic Drugs is an affordable, helpful reference tool for both students and clinicians alike. Bundle this Pocket Guide with additional Jones & Bartlett texts, and save up to 30%! Ask your Account Specialist about bundle options and bulk purchase specials for your program!
- Brand: Brand: Jones Bartlett Learning
- ASIN: 1449664989
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Drugs and the Pharmaceutical Sciences) (Volume
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products―from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage fo...
- Brand: Brand: CRC Press
- ASIN: 1420086359
The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth
This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
- ASIN: 1627346171
Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter.How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. As Greene reveals in this fascinating account, questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" an...
- ASIN: B00N51594S
The LDN Book: How a Little-Known Generic Drug _ Low Dose Naltrexone _ Could Revolutionize Treatment for Autoimmune Diseases, Cancer, Autism, Depression, and
Low Dose Naltrexone (LDN) holds the potential to help millions of people suffering from various autoimmune diseases and cancers, and even autism, chronic fatigue, and depression, find relief. Administered off-label in small daily doses (0.5 to 4.5 mg), this generic drug is extremely affordable and presents few known side effects. So why has it languished in relative medical obscurity? The LDN Book explains the drug’s origins, its primary mechanism, and the latest research from practicing physicians and pharmacists as compiled by Linda Elsegood of The LDN Research Trust, the world’s largest LDN charity organization with over 19,000 members worldwide. Featuring ten chapters contributed by medical professionals on LDN’s efficacy and two patient-friendly appendices, The LDN Book is a comprehensive resource for doctors, pharmacists, and patients who want to learn more about how LDN is helping people now, and a clarion call for further research that could help millions more.
- Brand: Chelsea Green Pub Co
- ASIN: 1603586644
Authorized Generic Drugs: Short and Long-Term Competitive Effects (Pharmacology - Research, Safety Testing and
Rising health care costs have for many years focused congressional attention upon the development and availability of prescription drugs. Recently, the presence of authorised generic pharmaceuticals in the drug marketplace has been the subject of congressional concern. An authorised generic is a pharmaceutical that is marketed by or on behalf of a brand-named drug company, but is sold under a generic name. The brand-name firm may distribute the drug under its own auspices or via a license to a generic drug company. The price of this authorised copy is ordinarily lower than that of the brand-name drug. Some sources refer to authorised generics as branded, flanking, or pseudo generics. This book presents an analysis of the innovation and public health issues relating to authorised generic drugs beginning with a review of the procedures through which independent generic drug companies receive government permission to market their products and resolve patent disputes with brand-name firms and consumer welfare.
- Brand: Brand: Nova Science Publishers
- ASIN: 1622570758
Memorizing Pharmacology: A Relaxed Approach to Learning the Top 200 Brand and Generic Drugs by
Can you learn pharmacology in a day? Yes.Whether you're studying for the NCLEX, NAPLEX, USMLE Step-1, PANCE, or just want to pass a pharmacology exam tomorrow, it is a subject you need to, but don't want to deal with. As a working parent of 7-year-old triplet daughters, I understand time management presents one of the greatest barriers to my pharmacology students' success. Many students feel cold overwhelm and information overload.After this book. This easy-to-read guide organizes pharmacology into manageable, logical steps you can fit in short pockets of time. The proven system helps you memorize medications quickly and form immediate connections. With mnemonics from students and instructors, you'll see how both sides approach learning.After you've finished the 200 Top Drugs in this book, reading pharmacology exam questions will seem like reading plain English. You'll have a new understanding of pharmacology to do better in class, clinical and your board exam. You'll feel the confidence you'd hoped for as a future health professional.The secret is that if you learn drugs in a certain order, you can remember them for as long as you like.
- ASIN: B01D6GQHKQ
Bottles Of Lies : Ranbaxy and the Dark Side of Indian
In 2004, Dinesh Thakur, a senior employee of Ranbaxy, then India s largest pharma company, discovered a terrible secret. Ranbaxy had been fabricating the test results of their drugs,endangering millions of patients. Thakur resigned and became a whistleblower to the US Food and Drug Administration, one of the regulators Ranbaxy had been lying to, and ultimately brought the multibillion-dollar behemoth to its knees. This is the sensational account of the high-stakes chase to bring Ranbaxy to book and the fall from grace of one of corporate India s biggest success stories.But the rot in Indian pharma isn t confined to Ranbaxy alone. In this book, investigative journalist Katherine Eban relies on over 20,000 FDA documents and interviews with over 240 people to show how fraud and trickery are deeply entrenched in much of the industry in India, and raises troubling questions about some of its biggest names Wockhardt, Dr Reddy s,Glenmark and RPG Life Sciences. Filled with shocking and eye-opening details, this book laysbare the ugly truth of Indian pharma. It will make you view every pill you take with foreboding and suspicion.
- ASIN: 9353450446
Complete Guide to Prescription & Nonprescription Drugs
The classic guide to all major prescription and nonprescription drugs, featuring revised, up-to-date FDA information and an A–Z list of illnesses for easy reference. Includes coverage of dosage and length of time before a drug takes effect; side effects; special precautions; interactions with other food and drugs; standards for use by different age groups; and more.
- ASIN: 0143131982
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