The Copy Generic

Author : Scott MacLochlainn
Publisher : University of Chicago Press
Page : 242 pages
File Size : 41,5 Mb
Release : 2022-11-25
Category : Religion
ISBN : 9780226822778

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The Copy Generic by Scott MacLochlainn Pdf

An illuminating look at the concept of the generic and its role in making meaning in the world. From off-brand products to elevator music, the “generic” is discarded as the copy, the knockoff, and the old. In The Copy Generic, anthropologist Scott MacLochlainn insists that more than the waste from the culture machine, the generic is a universal social tool, allowing us to move through the world with necessary blueprints, templates, and frames of reference. It is the baseline and background, a category that orders and values different types of specificity yet remains inherently nonspecific in itself. Across arenas as diverse as city planning, social media, ethnonationalism, and religion, the generic points to spaces in which knowledge is both overproduced and desperately lacking. Moving through ethnographic and historical settings in the Philippines, Europe, and the United States, MacLochlainn reveals how the concept of the generic is crucial to understanding how things repeat, circulate, and are classified in the world.

Author : Scott MacLochlainn
Publisher : University of Chicago Press
Page : 242 pages
File Size : 46,9 Mb
Release : 2022-11-25
Category : Social Science
ISBN : 9780226822761

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The Copy Generic by Scott MacLochlainn Pdf

An illuminating look at the concept of the generic and its role in making meaning in the world. From off-brand products to elevator music, the “generic” is discarded as the copy, the knockoff, and the old. In The Copy Generic, anthropologist Scott MacLochlainn insists that more than the waste from the culture machine, the generic is a universal social tool, allowing us to move through the world with necessary blueprints, templates, and frames of reference. It is the baseline and background, a category that orders and values different types of specificity yet remains inherently nonspecific in itself. Across arenas as diverse as city planning, social media, ethnonationalism, and religion, the generic points to spaces in which knowledge is both overproduced and desperately lacking. Moving through ethnographic and historical settings in the Philippines, Europe, and the United States, MacLochlainn reveals how the concept of the generic is crucial to understanding how things repeat, circulate, and are classified in the world.

Author : Leon Shargel,Isadore Kanfer
Publisher : CRC Press
Page : 288 pages
File Size : 47,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020038

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Generic Drug Product Development by Leon Shargel,Isadore Kanfer Pdf

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Author : Cori Hayden
Publisher : Duke University Press
Page : 137 pages
File Size : 40,8 Mb
Release : 2022-12-26
Category : Social Science
ISBN : 9781478023678

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The Spectacular Generic by Cori Hayden Pdf

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.

Author : Jeremy A. Greene
Publisher : Johns Hopkins University Press
Page : 375 pages
File Size : 54,9 Mb
Release : 2016-09-01
Category : Medical
ISBN : 9781421421643

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Generic by Jeremy A. Greene Pdf

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.

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 592 pages
File Size : 45,8 Mb
Release : 2002-08-15
Category : Medical
ISBN : 9781000611328

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Handbook of Biogeneric Therapeutic Proteins by Sarfaraz K. Niazi Pdf

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

Author : Gregory N. Carlson,Francis Jeffry Pelletier
Publisher : University of Chicago Press
Page : 490 pages
File Size : 54,6 Mb
Release : 1995-08
Category : Language Arts & Disciplines
ISBN : 0226092917

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The Generic Book by Gregory N. Carlson,Francis Jeffry Pelletier Pdf

In an attempt to address the theoretical gap between linguistics and philosophy, a group of semanticists, calling itself the Generic Group, has worked to develop a common view of genericity. Their research has resulted in this book, which consists of a substantive introduction and eleven original articles on important aspects of the interpretation of generic expressions. The introduction provides a clear overview of the issues and synthesizes the major analytical approaches to them. Taken together, the papers that follow reflect the current state of the art in the semantics of generics, and afford insight into various generic phenomena.

Author : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 341 pages
File Size : 44,6 Mb
Release : 2023-12-04
Category : Science
ISBN : 9783527333264

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Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf

Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Author : Donald O. Beers,Kurt R. Karst
Publisher : Wolters Kluwer
Page : 2154 pages
File Size : 43,9 Mb
Release : 2013-05-22
Category : Law
ISBN : 9781454836094

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Generic and Innovator Drugs by Donald O. Beers,Kurt R. Karst Pdf

Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.

Author : Anonim
Publisher : U.S. Government Printing Office
Page : 94 pages
File Size : 51,7 Mb
Release : 1998
Category : Business & Economics
ISBN : PURD:32754071785707

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How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry by Anonim Pdf

Author : Julie Rovner
Publisher : SAGE
Page : 329 pages
File Size : 54,7 Mb
Release : 2009
Category : Medical
ISBN : 9780872897762

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Health Care Policy and Politics A to Z by Julie Rovner Pdf

Drawing on over two decades of experience covering health policy on Capitol Hill, National Public Radio journalist Julie Rovner has written explanations for over 300 key concepts to demystify the world of health care policy in the United States. The third edition of Health Care Policy and Politics A to Z has been completely updated and now includes many new entries. Readers will find updated information on long term health care spending, abortion, Medicaid and Medicare, health insurance and the uninsured, and the State Childrens Health Insurance Program (SCHIP). New entries reflect important changes in recent years and include the Medicare Modernization Act, abstinence education, electronic health records, health savings accounts, Plan B, the Presidents Emergency Plan for AIDS Relief (PEPFAR), and Project BioShield.

Author : United States. Congress. House. Select Committee on Aging. Subcommittee on Housing and Consumer Interests
Publisher : Unknown
Page : 248 pages
File Size : 47,8 Mb
Release : 1990
Category : Aged
ISBN : PSU:000017170796

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Rx for Generic Drug Safety by United States. Congress. House. Select Committee on Aging. Subcommittee on Housing and Consumer Interests Pdf

Author : Jean-Noël Kapferer
Publisher : Kogan Page Publishers
Page : 576 pages
File Size : 49,8 Mb
Release : 2008
Category : Business & Economics
ISBN : 9780749450854

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The New Strategic Brand Management by Jean-Noël Kapferer Pdf

Adopted internationally by business schools, MBA programmes and marketing practitioners alike, The New Strategic Brand Management is simply the reference source for senior strategists, positioning professionals and postgraduate students. Over the years it has not only established a reputation as one of the leading works on brand strategy but also has become synonymous with the topic itself. The new edition builds on this impressive reputation and keeps the book at the forefront of strategic brand thinking. Revealing and explaining the latest techniques used by companies worldwide, author Jean-Noël Kapferer covers all the leading issues faced by the brand strategist today, supported by an array of international case studies. With both gravitas and intelligent insight, the book reveals new thinking on a wealth of topics including: brand architecture and diversity strategies; market adaptation approaches; positioning in the private label and store brand environment, and much, much more. Whether you work for an international company seeking to leverage maximum financial value for your brand, or whether you are looking for practical guidance on brand management itself, Kapferer's market-leading book is the one you should be reading to develop the most robust and watertight approach for your company.

Author : Bruce A. Hird
Publisher : Lulu.com
Page : 421 pages
File Size : 55,5 Mb
Release : 2019-05-16
Category : Education
ISBN : 9781483493732

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Business Letter and E-mail Writing: An Indexed Handbook by Bruce A. Hird Pdf

This book is a collection of nearly 250 shortened or adapted business letters that were actually emailed, faxed, or posted. While the letters vary in complexity and length, all samples are comprised of straightforward sentences that upper intermediate readers of English as a second language should have no difficulty understanding and using. The book should also be useful for native English speakers seeking a fundamental approach to written business communication and for teachers in need of business-writing source material and exercises. The book is divided into three parts: Part 1: Letter samples and answers to the exercises (usually letter revisions). Part 2: Exercises (original letters, situational assignments, and sequencing assignments). Part 3: Hotel and travel matters.

Author : Anonim
Publisher : Unknown
Page : 206 pages
File Size : 40,8 Mb
Release : 1997
Category : Veterinary drugs
ISBN : MINN:31951P00897392Z

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FDA Veterinarian by Anonim Pdf