Analytical Similarity Assessment in Biosimilar Product Development, Chow, Shein-Chung
Автор: Karen M. Nagel Название: Introduction to Biologic and Biosimilar Product Development and Analysis ISBN: 3030074927 ISBN-13(EAN): 9783030074920 Издательство: Springer Рейтинг: Цена: 102480.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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: Karen M. Nagel Название: Introduction to Biologic and Biosimilar Product Development and Analysis ISBN: 3319984276 ISBN-13(EAN): 9783319984278 Издательство: Springer Рейтинг: Цена: 83850.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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: 188850.00 T 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: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 183750.00 T 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.
Автор: Kerry B. Barker, Sandeep M. Menon, Ralph B. D`Agostino, Siyan Xu, Bo Jin Название: Biosimilar Clinical Development: Scientific Considerations and New Methodologies ISBN: 1482231697 ISBN-13(EAN): 9781482231694 Издательство: Taylor&Francis Рейтинг: Цена: 132710.00 T Наличие на складе: Нет в наличии. 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: Chow, Shein-Chung Название: Biosimilars ISBN: 1466579692 ISBN-13(EAN): 9781466579699 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Biologics and biosimilars ISBN: 1138594229 ISBN-13(EAN): 9781138594227 Издательство: Taylor&Francis Рейтинг: Цена: 132710.00 T 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: 65320.00 T 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: Sarfaraz K. Niazi Название: Biosimilars and Interchangeable Biologics: Strategic Elements ISBN: 1138775509 ISBN-13(EAN): 9781138775503 Издательство: Taylor&Francis Рейтинг: Цена: 107190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
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.
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: 158380.00 T 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: P.M. Dean Название: Molecular Similarity in Drug Design ISBN: 9401045895 ISBN-13(EAN): 9789401045896 Издательство: Springer Рейтинг: Цена: 186330.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Molecular similarity searching is fast becoming a key tool in organic chemistry. The chapters focus principally on those methods which have reached sufficient maturity to be of immediate practical use in molecular design.
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