Gutka Hiten J., Yang Harry, Kakar Shefali Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development 9783319996790

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Автор: Gutka Hiten J., Yang Harry, Kakar Shefali
Название: Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development
ISBN: 9783319996790
Издательство: Springer
Классификация:

Фармакология

Аптечная служба и отпуск лекарственных средств

Промышленная химия

Технологии производства фармацевтических препаратов

Экспертные системы / системы баз знаний

ISBN-10: 3319996797
Обложка/Формат: Hardcover
Страницы: 709
Вес: 1.20 кг.
Дата издания: 06.11.2018
Серия: Aaps advances in the pharmaceutical sciences series
Язык: English
Издание: 1st ed. 2018
Иллюстрации: 93 illustrations, color; 25 illustrations, black and white; xxiii, 709 p. 118 illus., 93 illus. in color.; 93 illustrations, color; 25 illustrations,
Размер: 234 x 156 x 40
Читательская аудитория: Professional & vocational
Подзаголовок: Regulatory, clinical, and biopharmaceutical development
Ссылка на Издательство: Link
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Поставляется из: Германии
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.
Дополнительное описание: Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape.- Biosimilars 101 – An Introduction to Biosimilars.- Innovation, Patents and Biologics: The Road to Biosimilar Competition.- Factors influencing investment,

Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development, Gutka Hiten J., Yang Harry, Kakar Shefali