Generic Pharmaceuticals
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Generic Drug Development Project Management
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Author : Sandeep Narayan Patil, PMP
language : en
Publisher: Notion Press
Release Date : 2021-04-17
Generic Drug Development Project Management written by Sandeep Narayan Patil, PMP and has been published by Notion Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-17 with Medical categories.
This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
Generic Drugs
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Author : Ryan S. Blanton
language : en
Publisher:
Release Date : 2009
Generic Drugs written by Ryan S. Blanton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Generic drugs categories.
The practice of "authorised generics" has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An "authorised generic" (sometimes termed a "branded", "flanking", or "pseudo" generic) is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favourable to consumers, authorised generics have nonetheless proven controversial. Some observers believe that authorised generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products. This book presents an analysis of the innovation and public health issues relating to authorised generic drugs. The book begins 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. It also provides detailed background information pertaining to the concept of authorised generics and assesses their potential impact upon patent challenges and consumer welfare, as well as a summary of congressional issues and possible alternatives.
How Increased Competition From Generic Drugs Has Affected Prices And Returns In The Pharmaceutical Industry
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Author :
language : en
Publisher: U.S. Government Printing Office
Release Date : 1998
How Increased Competition From Generic Drugs Has Affected Prices And Returns In The Pharmaceutical Industry written by and has been published by U.S. Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Business & Economics categories.
Greater Access To Generic Drugs
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Author : Michelle Meadows
language : en
Publisher:
Release Date : 2003
Greater Access To Generic Drugs written by Michelle Meadows and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Drugs categories.
Generic
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Author : Jeremy A. Greene
language : en
Publisher: Johns Hopkins University Press
Release Date : 2016-09-01
Generic written by Jeremy A. Greene and has been published by Johns Hopkins University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-01 with Medical categories.
Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2007-11-15
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-15 with Medical categories.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp
Bottle Of Lies
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Author : Katherine Eban
language : en
Publisher: HarperCollins
Release Date : 2020-06-23
Bottle Of Lies written by Katherine Eban and has been published by HarperCollins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-23 with Medical categories.
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.
The Generic Challenge
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Author : Martin A. Voet
language : en
Publisher: BrownWalker Press
Release Date : 2020-05-01
The Generic Challenge written by Martin A. Voet and has been published by BrownWalker Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-01 with Law categories.
This Sixth 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.
The Spectacular Generic
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Author : Cori Hayden
language : en
Publisher: Duke University Press
Release Date : 2022-12-26
The Spectacular Generic written by Cori Hayden and has been published by Duke University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-26 with Social Science categories.
In The Spectacular Generic, Cori Hayden examines how generic drugs have transformed public health politics and everyday experiences of pharmaceutical consumption in Latin America. Focusing on the Mexican pharmacy chain Farmacias Similares and its proprietor, Víctor González Torres, Hayden shows how generics have become potent commodities in a postpatent world. In the early 2000s, González Torres, a.k.a. “Dr. Simi,” capitalized on the creation of new markets for generic medicines, selling cheaper copies of leading-brand drugs across Latin America. But Dr. Simi has not simply competed with the transnationals; his enterprise has also come to compete with the Mexican state, reorganizing the provision of medicine and basic health care for millions of people. Hayden juxtaposes this story with Dr. Simi’s less successful efforts in Argentina, where he confronted a radically different configuration of pharmaceutical politics. Building from these diverging trajectories, Hayden illuminates the politics of generic substitution as a question that goes beyond substituting one drug for another. Generic politics can radically reshape the relations among consumers, states, and pharmaceutical markets, even as they have yet to resolve the problems of cost and access.
Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica