药物动力学建模以优化基于mAb的疗法的开发和治疗潜力
Xiaoqing Fan1, Chengcong Chen1, Lin Zhang1
1Guangdong-Hong Kong-Macao Joint Laboratory for New Drug Screening, School of Pharmacy, The Chinese University of Hong Kong, Hong Kong, SAR, PR China.
Advanced drug delivery reviews
|March 9, 2026
概括
药物动力学建模对于推进单克隆抗体 (mAb) 疗法至关重要. 先进的建模技术改善了这些复杂的生物药物的开发和优化,以获得更好的患者结果.
科学领域:
- 药理学和药物开发领域
- 生物技术是生物技术.
- 免疫治疗是一种免疫疗法.
背景情况:
- 单克隆抗体 (mAbs) 正在彻底改变医学,有超过200种已批准的药物和许多针对各种疾病的候选药物.
- 模式多样化 (双特异性抗体,抗体-药物合物) 提高了选择性和效力,但引入了复杂的药理学挑战.
- 传统的药理动力学 (PK) 模型与mAb特定的行为 (如目标介导药物排放 (TMDD)) 斗争.
研究的目的:
- 审查高级PK建模在单克隆抗体 (mAb) 药物发现和开发中的关键作用.
- 突出 PK 建模是如何解决复杂抗体架构带来的独特挑战的.
- 强调PK建模对优化抗体治疗药物的有效性和安全性的贡献.
主要方法:
- 审查机械PK建模方法,包括TMDD模型,基于生理学的PK (PBPK) 建模和系统药理学.
- 机器学习 (ML) 和人工智能 (AI) 的整合用于参数推断和预测改进.
- 应用PK建模用于临床前临床转换,剂量选择和暴露-反应分析.
主要成果:
- 先进的PK建模使得从临床前数据到人体试验的定量翻译成为可能.
- 基于模型的方法促进了合理的首次人体剂量选择和治疗方案优化.
- PK建模有助于评估免疫性影响和平衡治疗疗效与安全.
结论:
- 对于基于mAb的疗法的高效和精确开发,PK建模是不可或缺的.
- 新型建模工具和AI/ML集成加速药物开发并扩大治疗潜力.
- 在PK建模方面的持续创新将确保在患者群体中针对抗体治疗的最佳结果.
关键词:
抗体药物联结物 抗体药物联结物双特异性抗体 双特异性抗体单克隆抗体是一种单克隆抗体.在 PBPK 建模中使用 PBPK 模型.在 PK 建模中,PK 建模是目标介导的药物处置是指通过目标介导的药物处置.基于mAb的治疗方法更多相关视频
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