Analytical Similarity Assessment in Biosimilar Product Development, Chow, Shein-Chung
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Описание: Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
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: 23757.00 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.
Автор: Jean-Louis Prugnaud; Jean-Hugues Trouvin Название: Biosimilars ISBN: 2817805143 ISBN-13(EAN): 9782817805146 Издательство: Springer Рейтинг: Цена: 16769.00 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.
Автор: Niazi Название: Biosimilarity The Fda Perspective ISBN: 1498750397 ISBN-13(EAN): 9781498750394 Издательство: Taylor&Francis Рейтинг: Цена: 28327.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
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: Lee Sang Joon, Chow Shein-Chung Название: Methodologies in Biosimilar Product Development ISBN: 0367896346 ISBN-13(EAN): 9780367896348 Издательство: Taylor&Francis Рейтинг: Цена: 28327.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Methodologies in Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product.
Автор: Chow, Shein-Chung Название: Biosimilars ISBN: 1466579692 ISBN-13(EAN): 9781466579699 Издательство: Taylor&Francis Рейтинг: Цена: 22202.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Biologics and biosimilars ISBN: 1138594229 ISBN-13(EAN): 9781138594227 Издательство: Taylor&Francis Рейтинг: Цена: 19906.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Biologics and Biosimilars: Drug Development and Clinical Affairs is a systematic integration and evaluation of all aspects of biologics and biosimilars, R&D and clinical use, global regulation, and more.
Автор: Chow, Shein-Chung Название: Biosimilars ISBN: 0367379724 ISBN-13(EAN): 9780367379728 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 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.
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