生物制药专业英语(修订版)

作者简介

马超，韩语博士，贵阳理工学院制药工程学院副教授。 刘丽萍，生物工程医学博士，贵阳理工学院制药工程学院副教授。

内容简介

Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice. 本书为制药学院高校规划教材，修订后更适合高校教学使用