| 引用本文: | 郭莎,许东泽,李涵涵,祁志云,吴昊.对静脉输注抗体类药物在临床使用中影响药品质量相关因素的探讨[J].中国现代应用药学,2024,41(18):79-86. |
| guo sha,xu dong ze,li han han,qi zhi yun,wu hao.An Exploration of Factors Affecting Drug Quality in the Clinical Use of Intravenous Antibody Infusions[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(18):79-86. |
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| 摘要: |
| 抗体药物作为发展最快的生物药物，如今广泛应用于自身免疫性疾病和癌症等疾病治疗。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。本文总结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。 |
| 关键词: 抗体类药物 使用中研究 使用中稳定性 使用中相容性 |
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| An Exploration of Factors Affecting Drug Quality in the Clinical Use of Intravenous Antibody Infusions |
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guo sha1, xu dong ze2, li han han2, qi zhi yun2, wu hao2
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1.National Institutes for Food and Drug Control;2.Shenyang Pharmaceutical University
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| Abstract: |
| Antibody drugs, as the fastest-growing biopharmaceuticals, are now widely used in the treatment of autoimmune diseases and cancer. 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 summarizes the factors that may affect the quality of antibody drugs during clinical use and briefly introduces the design and concerns of studies related to their use, providing a reference for research on the clinical application of antibody drugs. |
| Key words: antibody drugs in-use study in-use stability in-use compatibility |
