生物制品质量标准研究与建立一般原则的探讨

Principles for specification establishment of biological products

生物制品成分多样,结构复杂,质量标准需根据产品特点拟定。生物制品质量标准的研究建立系综合药学、临床前、临床试验研究及上市后研究结果开发、确认和不断完善的过程,质量标准研究贯穿整个药品的生命周期。本文结合国际技术指南及实际审评案例,对生物制品质量标准研究及建立的一般原则进行了探讨,以期为生物制品研发和评价工作提供参考。

Biologics are highly heterogeneous in compositions and complicated in structures, whose specifications should be product-specific based on full characterization of the products. The establishment of specifications is a comprehensive process chemistry manufacture and controls （CMC which exists throughout the whole life cycle to standardize the specifications design, qu study, pre- the product alification and clinical study, This article d continued verification of the results of clinical study and post-marketing study iscussed the general considerations of how biological products, taking the international technical guidelines and some real cases of new drug review into consideration, to provide reference for industry and reviewers