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Updated: Jan 14, 2026

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关于利用生理学基础生物制药建模 (PBBM) 为BCS III类生物豁免者的新兴观点:网络研讨会摘要

Lanyan Fang1, Shereeni Veerasingham2, Yunming Xu3

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Journal of pharmaceutical sciences
|October 20, 2025
PubMed
概括

生物制药分类系统 (BCS) 第三类药物产品可以使用基于生理学的生物制药建模 (PBBM) 来简化生物豁免. 这种方法可以应对监管挑战,并为药物开发提供实际解决方案.

关键词:
在BCS中,BCS是指BCS.生物废弃物 生物废弃物溶解安全空间是一个溶解安全空间.辅助物质 辅助物质 辅助物质PBBM (生理学基础的生物制药建模)有关监管的监管机构虚拟生物等价性 (VBE) 是指

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