静脉输注抗体类药物在临床使用中的药品质量影响因素探讨
Exploration of Factors Affecting Drug Quality in the Clinical Use of Intravenous Antibody Infusions
郭莎 1许东泽 2李涵涵 2祁志云 3吴昊2
作者信息
- 1. 中国食品药品检定研究院,北京 102629
- 2. 沈阳药科大学制药工程学院,沈阳 110000
- 3. 中国食品药品检定研究院,北京 102629;沈阳药科大学制药工程学院,沈阳 110000
- 折叠
摘要
抗体药物作为发展最快的生物药,已被广泛应用于自身免疫性疾病和肿瘤等疾病治疗.抗体药物作为蛋白质药物,具有不稳定性,质量受到监管部门严格管控.然而,静脉输注抗体类药物在临床使用中相关研究较少,可能存在风险隐患,影响患者用药安全.本文综述了抗体药物在临床使用过程中可能影响药品质量的相关因素,并简单介绍了使用中研究设计及顾虑,为抗体药物的使用中研究提供参考.
Abstract
Antibody drugs,as the fastest-growing biopharmaceuticals,are now widely used in the treatment of autoimmune diseases and tumor.As protein drugs,antibody drugs are inherently unstable and their quality is strictly regulated by regulatory authorities.However,there is limited research on the clinical use of antibody drugs,which may pose potential risks and impact patient safety.This paper summarized the factors that maight affect the quality of antibody drugs during clinical use and briefly introduced the design and concerns of studies related to their usage,providing a reference for research on the clinical application of antibody drugs.
关键词
抗体类药物/使用中/使用中稳定性/使用中相容性Key words
antibody drugs/in-use/in-use stability/in-use compatibility引用本文复制引用
出版年
2024
NETL
NSTL
万方数据