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Generic And Innovator Drugs
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Book Synopsis Generic Drug Product Development by : Leon Shargel
Download or read book Generic Drug Product Development written by Leon Shargel and published by CRC Press. This book was released on 2013-10-24 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Generic written by Jeremy A. Greene and published by JHU Press. This book was released on 2014-10-27 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: The turbulent history of generic pharmaceuticals raises powerful questions about similarity and difference in modern medicine. 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" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. 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.
Book Synopsis How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry by :
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Generic drug entry prior to patent expiration an FTC study by :
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Book Synopsis Excipient Applications in Formulation Design and Drug Delivery by : Ajit S Narang
Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.
Book Synopsis Diagnostics and Therapy in Veterinary Dermatology by : Dawn Logas
Download or read book Diagnostics and Therapy in Veterinary Dermatology written by Dawn Logas and published by John Wiley & Sons. This book was released on 2021-10-08 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diagnostics and Therapy in Veterinary Dermatology presents thorough coverage of the latest discoveries, drugs, and treatments for dermatologic conditions in animals. Chapters written by experts in each respective area of veterinary dermatology contain up-to-date information on new diagnostic tools and tests, autoimmune diseases, parasitic and fungal infections, medical management of acute and chronic conditions, alternative dermatologic therapies, and more. Offering practical solutions for both specialist and general practice veterinarians dealing with dermatology cases, this wide-ranging resource also addresses antibiotic resistance and misuse, the availability of foods for elimination diet trials, problems with generic drugs, emerging infectious diseases, and other important problems currently facing the profession. Throughout the text, veterinary practitioners are provided with real-world guidance on improving how they work up their dermatology cases and strengthening communication between the primary care veterinarian and the dermatologist. Edited by a leading board-certified dermatologist, this volume: Focuses on cats and dogs Includes numerous high-quality clinical photographs illustrating all key concepts Covers topics such as how to use your nursing staff to the fullest, the One Health movement, and how changing climate is increasing the spread of certain dermatologic diseases Discusses approaches for building a better working relationship between clients, primary care veterinarians and dermatologists Provides insights on the future of technology in the diagnosis and treatment of dermatologic diseases Covering the very latest developments in the field, Diagnostics and Therapy in Veterinary Dermatology is essential reading for veterinary dermatologists, veterinary students, and any veterinary general practitioner with a dermatology caseload.
Book Synopsis Approved Prescription Drug Products by :
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Book Synopsis Generic Drug Product Development by : Isadore Kanfer
Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Generic and Innovator Drugs by : Donald O. Beers
Download or read book Generic and Innovator Drugs written by Donald O. Beers and published by Wolters Kluwer. This book was released on 2013-05-22 with total page 2154 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Therapy for Severe Psoriasis E-Book by : Jashin J. Wu
Download or read book Therapy for Severe Psoriasis E-Book written by Jashin J. Wu and published by Elsevier Health Sciences. This book was released on 2016-12-02 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: A brand-new title in the field of dermatology, Therapy for Severe Psoriasis provides the ultimate coverage of the treatment options available for today's most serious cases, including biologics and oral therapies. It features discussions of the newest drug therapies, recent FDA-approved biosimilars, and combination approaches to care, while an overview chapter was designed to aid those new to the field in understanding the nuances of difficult-to-treat subtypes of psoriasis. Comprehensive and focused, Therapy for Severe Psoriasis will be a welcome addition to the library of any dermatologist seeking in-depth information on the challenges of this condition. - Each of the 16 chapters includes either an in-depth focus on a single therapy or an overview of a unique aspect of psoriasis, including: UVB therapy, methotrexate, acitretin, cyclosporine, apremilast, etanercept, infliximab, adalimumab, ustekinumab, secukinumab, and ixekizumab. - Takes an evidence-based approach to hard-to-treat severe psoriasis. - Discusses the newest drug therapies (such as ixekizumab), plus recent FDA-approved biosimilars, a topic unique to this particular psoriasis text. - Presents combination approaches for instances when standard treatments are not successful. - Includes an overview chapter to help beginners understand the nuances of the disorder.
Book Synopsis Innovation, Economic Development, and Intellectual Property in India and China by : Kung-Chung Liu
Download or read book Innovation, Economic Development, and Intellectual Property in India and China written by Kung-Chung Liu and published by Springer Nature. This book was released on 2019-09-06 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.
Book Synopsis Clinical Pharmacokinetics by : Malcolm Rowland
Download or read book Clinical Pharmacokinetics written by Malcolm Rowland and published by . This book was released on 1989 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since pharmacokinetics can greatly affect how different patients respond to the same drug, both students and physicians need a basic clinical understanding of this vital area. The Third Edition of Clinical Pharmacokinetics provides a practical perspective, with these added features considerations of both stereochemistry and the increasing number of polypeptide and protein drugs being developed; the range and number of problems at the end of each chapter has been expanded; a second color added to make the text more user friendly; important equations highlighted by shading.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Encyclopedia of Pharmacy Practice and Clinical Pharmacy by :
Download or read book Encyclopedia of Pharmacy Practice and Clinical Pharmacy written by and published by Academic Press. This book was released on 2019-06-28 with total page 2370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos
Book Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan
Download or read book Biologics, Biosimilars, and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
