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Updated: Jul 12, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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在试点生物可用性/生物等价性研究中,Cmax生物等价性的预测潜力,通过替代 ƒ2相似性因子方法

Sara Carolina Henriques1,2, Paulo Paixão1, Luis Almeida2

  • 1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, 1649-003 Lisboa, Portugal.

Pharmaceutics
|October 28, 2023
PubMed
概括

试点生物可用性/生物等价性研究可以使用几何平均值 (Gmean) f2因子来更好地做出决策. 这种方法有助于确定是否需要关键研究,特别是具有更高可变性的研究.

关键词:
生物等价性 生物等价性仿制药是指一般的药物.建模和模拟的模型和模拟.药物动力学模拟 药物动力学模拟药物动力学 药物动力学试点研究试点研究ƒ2因子 ƒ2因子

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