Автор: Chow, Shein-Chung Название: Biosimilars ISBN: 1466579692 ISBN-13(EAN): 9781466579699 Издательство: Taylor&Francis Рейтинг: Цена: 23734.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Chow, Shein-Chung Название: Biosimilars ISBN: 0367379724 ISBN-13(EAN): 9780367379728 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products.
Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products.
Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
Автор: Jean-Louis Prugnaud; Jean-Hugues Trouvin Название: Biosimilars ISBN: 2817805143 ISBN-13(EAN): 9782817805146 Издательство: Springer Рейтинг: Цена: 14635.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Описание: The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Описание: The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Автор: Gutka Hiten J., Yang Harry, Kakar Shefali Название: Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development ISBN: 3319996797 ISBN-13(EAN): 9783319996790 Издательство: Springer Рейтинг: Цена: 20733.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Автор: W.-H. Boehncke; H.H. Radeke Название: Biologics in General Medicine ISBN: 364243567X ISBN-13(EAN): 9783642435676 Издательство: Springer Рейтинг: Цена: 20733.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The idea for this book was born during the symposium on biologics organized by ZAFES (Center for Drug Research, Development and Safety at the University of Frankfurt am Main) in September 2005. Highly distinguished researchers special- ing in the field of biologics had gathered together to exchange information on this relatively new subject. Realizing that this symposium was one of the few sources of condensed information on biologics, it became obvious that we had to create a means of informing an interested wider circle of scientists and especially general c- nicians. Therefore, the editors of this book suggested to the researchers at the symposium andalsotoprominent scientists andcliniciansinvolvedinthe developmentand application of biologics as their major field of interest the idea of assembling this compendium. We received an overwhelmingly positive response – thankfully also from the publisher – most being more than willing to support this innovative project with highly relevant chapters on the latest state of the art. As we were eager to fill the information gap with up-to-date knowledge, the project had to be finished within the shortest time possible. To all experienced with editing this was obviously a ch- lengeand we areverythankfultoall thecontributorsthatour timeline hadtobe extended by only a few months. This book represents a collection of the most recent knowledge on biologics written by people who have been active in the field for many years. Wolf-Henning Boehncke Heinfried H. Radeke Contents 1 Introduction: Definition and Classification of Biologics W. -H. Boehncke, H. H. Radeke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Описание: The use of biologics - drugs made from living organisms - has raised specific scientific, industrial, medical and legal issues. The essays contained in this collection each deal with a case study of a biologic substance, or group of biologics, and its use during the twentieth century.
Автор: Muttil Pavan, Kunda Nitesh K. Название: Mucosal Delivery of Drugs and Biologics in Nanoparticles ISBN: 3030359123 ISBN-13(EAN): 9783030359126 Издательство: Springer Цена: 24392.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: It provides an overview of nanotechnology in drug delivery with a description of different types of nanoparticles, methods of preparation and characterization, and functionalization for site-specific drug delivery.
Описание: Richard Garfield`s `Carnival Of Monsters` is being revamped by VR in 2019! The carnival is coming, ready to amaze with unusual creatures never seen before! As the master of your very own Carnival of Monsters, can you present the audience with the spectacle they demand by capturing the most magnificent menagerie of monsters? The carnival master who can explore the magical lands where these creatures dwell and bring back the finest specimens will know riches and fame galore. But be careful-not all monsters are peaceful, so keep a few hunters on hand to keep them from getting loose! Richard Garfield`s Carnival of Monsters is a card-drafting and set-collecting game for 2 to 5 players, ages 10 and up. In this approximately 45-minute game, players draft cards from their hands, trying to collect sets of matching lands so they can capture and display exotic creatures to earn victory points. Along the way, they can hire talented staff to aid their efforts, pursue their own secret goals, or take advantage of fortuitous events. At the end of each season, they must make sure that none of their monsters escape, while the player who can best meet the demands of the audience will be awarded with a bonus!
Автор: Weichang Zhou; Anne Kantardjieff Название: Mammalian Cell Cultures for Biologics Manufacturing ISBN: 3662522705 ISBN-13(EAN): 9783662522707 Издательство: Springer Рейтинг: Цена: 42688.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.
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