biosimilars and interchangeable biologics strategic elements

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Biosimilars And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 9781498743488
Genre : Medical
File Size : 48. 10 MB
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What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Biosimilarity

Author : Sarfaraz K. Niazi
ISBN : 9781315351377
Genre : Medical
File Size : 77. 64 MB
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The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy.

Biological Drug Products

Author : Wei Wang
ISBN : 9781118695227
Genre : Medical
File Size : 63. 79 MB
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Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.

United States Code

Author : United States
ISBN : OSU:32437123253821
Genre : Law
File Size : 36. 91 MB
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The Price Of Innovation New Estimates Of Drug Development Costs

Author : Christoph Fürleger
ISBN : 9783640791675
Genre : Business & Economics
File Size : 78. 55 MB
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Studienarbeit aus dem Jahr 2010 im Fachbereich VWL - Finanzwissenschaft, Universität Bayreuth, Sprache: Deutsch, Abstract: Die vom Bundesministerim für Gesundheit ausgewiesenen Arzneimittelausgaben in der GKV verzeichneten in den letzten 10 Jahren einen nominalen Anstieg um 54,56 Prozent. Der Anteil an den Gesamtausgaben der GKV stieg in diesem Zeitraum von 14,52 auf 17,57 Prozent (vgl. BMG (2010), S. 1). Für das Jahr 2010 errechnete der Schätzerkreis der gesetzlichen Krankenversicherungen im Oktober 2009 eine Deckungslücke von 7,45 Milliarden Euro zwischen den Einnahmen und Ausgaben im Gesundheitsfond (vgl. BVA Schätzerkreis (2009). Zur Entlastung der Ausgabenseite in der GKV werden daher zahlreiche Maßnahmen u.a. im Bereich der Arzneimittelversorgung diskutiert. Im Fokus stehen dabei im Besonderen patentgeschützte Arzneimittel. Für diese Produkte konnte die Pharmaindustrie bisher die Preise, bis zum Erstattungshöchstbetrag, frei festsetzen. Neben der Kosten-Nutzen- Bewertung und weiteren Faktoren sollen nach der aktuellen Gesetzeslage bei der Festlegung des Erstattungshöchstbetrags auch die Entwicklungskosten von Medikamenten berücksichtigt werden (vgl. § 31 Abs. 2a SGB V).

Congressional Record

Author : United States. Congress
ISBN : STANFORD:36105216617220
Genre : Law
File Size : 71. 20 MB
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The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is in session. The Congressional Record began publication in 1873. Debates for sessions prior to 1873 are recorded in The Debates and Proceedings in the Congress of the United States (1789-1824), the Register of Debates in Congress (1824-1837), and the Congressional Globe (1833-1873)

Pharmacopoea Helvetica Classic Reprint

Author : Switzerland Bundesrat
ISBN : 0666202427
Genre : Science
File Size : 90. 64 MB
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Excerpt from Pharmacopoea Helvetica Die ersten schweizerischen Pharmakopoen gingen nicht aus der Initiative der Behrden hervor, sondern waren private Unternehmun gen. So z. B. Das Antidotarlum geminam generale et speciale des Baseler Professors Joh. Lee. Wecker, das 1595 in Basel erschien und aus Weckers Antldotarlum speciale, Basel 1561, und dem Antidota rium generale, Basel 1585, des gleichen Verfassers zusammengezogen war, so die Pharmaeopma spagyrica des Zricher Apothekers Adrian Ziegler, Zrich 1616, u. A. Aber auch die 1677 in Genf erschienene Pharmaeopma Helvetiorum des lac. Constant de Rebecque war trotz ihres Titels ein privates Unternehmen und das gleiche gilt von der schnen Pharmacopma Helvetica, Basel 1771, zu der Albrecht von aller die Vorrede schrieb. Dieselbe trgt aber doch schon den Ver merk scitu et consensu gratiosi Collegii medici Basiliensis digesta, war also wenigstens halbamtlich. Das Gleiche gilt von der Phar macopma Genevensis ad usum nosocomiorum aus dem Jahre 1780 (sptere Auflagen 1783 und die von den Doktoren De la Roche, (wer und Dunant redigiert worden war und sowohl die Sim plicia wie die Composita enthielt. In der ersten Hlfte des XIX. Jahrhunderts waren in der Schweiz vorwiegend Pharmakopoen des Auslandes, besonders Deutschlands, in Benutzung, z. B. Die Pharmacoa Wrtembergica, die Pharma c0poea Badensis, und besonders die Pharmac0poea Borussica. In den franzsisch sprechenden Kantonen war die Pharmacop'e francaise in Benutzung, im Tessin vielfach die italienische Pharmakope. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works.

Journal Of The House Of Representatives Of The United States

Author : United States. Congress. House
ISBN : STANFORD:36105131834082
Genre : Legislation
File Size : 77. 43 MB
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Some vols. include supplemental journals of "such proceedings of the sessions, as, during the time they were depending, were ordered to be kept secret, and respecting which the injunction of secrecy was afterwards taken off by the order of the House."

Federal Register

Author :
ISBN : OSU:32437123241305
Genre : Delegated legislation
File Size : 76. 21 MB
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Federal Register Index

Author :
ISBN : MINN:31951P01137907X
Genre : Administrative law
File Size : 67. 84 MB
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