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「电子书」Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development 单克隆抗体的生物仿制药: 生产、临床前和临床研究的实用指南 PDF

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本书通过描述开发单克隆抗体(mAb)药物的生物仿制药所涉及的科学和过程来满足重大需求,涵盖了生物仿制药开发的所有方面:临床前、临床、监管、生产。


- 引导读者了解开发单克隆抗体(mAb)药物的生物仿制药所涉及的复杂情况

- 以流程图、表格和数字为特色,清楚地说明了流程,使本书易于理解和接受。

- 包括对FDA批准的mAb药物的回顾,作为对事实和有用信息的快速参考

- 研究了改进生物仿制药的新技术和策略


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.


• Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs

• Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible

• Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information

• Examines new technologies and strategies for improving biosimilar mAbs


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