可比性
免疫原性
药效学
药代动力学
关键质量属性
单克隆抗体
生物仿制药
医学
药理学
风险分析(工程)
计算生物学
新产品开发
抗体
生物
免疫学
业务
内科学
数学
营销
组合数学
作者
Wendy S. Putnam,Saileta Prabhu,Yanan Zheng,Meena Subramanyam,Yow‐Ming Wang
标识
DOI:10.1016/j.tibtech.2010.07.001
摘要
Regulatory guidance stipulates that comparability assessment is required to support manufacturing process changes during the development of a biological product or post-approval. However, strategies for assessing the comparability of pre- and post-change materials are still evolving. A hierarchical risk-based approach is recommended, starting with analytical testing to ensure quality, followed by biological characterization and, if needed, in vivo pharmacokinetic (PK), PK-pharmacodynamic (PD), safety and/or efficacy studies. The need for an in vivo study and the type of study required depend on the magnitude and the potential impact of the changes and the timing in the development process. This review discusses factors affecting the PK, PD and immunogenicity of monoclonal antibodies, and provides guidance for determining non-clinical and clinical comparability assessment strategies.
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