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.
Описание: * Greatly expanded and completely revised * Covers now not only drug application of biopharmaceuticals but also their use in diagnostics and vaccine development. * Includes material on quality control, safety issue, patent and legal regulations .
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.
Автор: Schoenwald Название: Pharmacokinetics in Drug Discovery and Development ISBN: 1566769736 ISBN-13(EAN): 9781566769730 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: From basic principles to industrial and regulatory applications to clinical and research applications, this book reviews the subspecialties in the field of pharmacokinetics. It covers topics such as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, and linear systems approaches.
Автор: Wang Название: Biological Drug Products: Development and Strategies ISBN: 1118148894 ISBN-13(EAN): 9781118148891 Издательство: Wiley Рейтинг: Цена: 24544.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book overviews the fundamental aspects, challenges, and strategies for developing a variety of biological drugs -- a large and growing segment of the pharmaceutical industry. Contributing authors discuss the development process, safety and clinical assessments, manufacturing, regulatory and intellectual property issues.
Описание: By guiding in the application of techniques and tools for predicting ADMET outcomes in drug candidates, Predictive ADMET offers a road map for drug discovery scientists to generate effective and safe drugs for unmet medical needs.
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