小编小结
参考文献
1.When three is not a crowd: trispecific antibodies for enhanced cancer immunotherapy.
2.A novel CD19/CD22/CD3 trispecific antibody enhances therapeutic efficacy and overcomes immune escape against B-ALL.
3.A recombinant trispecific single-chain Fv derivative directed against CD123 and CD33 mediates effective elimination of acute myeloid leukaemia cells by dual targeting.
4.Trispecific antibodies enhance the therapeutic efficacy of tumor-directed T cells through T cell receptor co-stimulation.
2024-07-16
2024-06-20
2024-06-24
2024-06-27
2024-07-13
2024-06-27
2024-06-12
随着敏捷开发和 AI 技术逐渐融入制药行业的合规管理,软件系统的定制化要求越来越高。本文主要从法规指南角度分析和评价定制软件验证的有效性。指导制药行业通过更加科学的风险管理手段开展验证,以实现系统选项、实施及测试过程的风险管控,保证后续运行阶段的 GXP 符合性。同时也满足《药品生产质量管理规范(2010 年修订)》计算机化系统 [1] 和《药品记录与数据管理要求(试行)》的要求 [2-3]。
作者:赵延武 程静 张文标 王军 张永秉
评论
加载更多