| 期刊全称 | Biosimilars | | 期刊简称 | Regulatory, Clinical | | 影响因子2023 | Hiten J. Gutka,Harry Yang,Shefali Kakar | | 视频video | | | 发行地址 | Discusses the regulatory landscape and policies that define and govern the approval of biosimilar therapeutics in different geographies.Focus on QbD and analytical similarity for biosimilar developmen | | 学科分类 | AAPS Advances in the Pharmaceutical Sciences Series | | 图书封面 |  | | 影响因子 | .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 a | | Pindex | Book 2018 |
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发表于 2025-3-21 17:34:42
