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Updated: Sep 15, 2025

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
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A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

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基于模型的方法用于生物等价性研究中的二阶段组序列或适应性设计,使用并行和交叉设计

Florence Loingeville1, Manel Rakez2, Thu Thuy Nguyen3

  • 1ULR 2694 - METRICS : Evaluation of Health Technologies and Medical Practices, University of Lille, CHU Lille, Lille, France.

Statistical methods in medical research
|July 14, 2025
PubMed
概括

这项研究表明,基于模型的TOST (MB-TOST) 是生物等价性研究的非分区分析TOST (NCA-TOST) 的可行替代方案. 两阶段设计,包括组序列和自适应设计,减少样本大小,特别是对于高度可变的药物.

关键词:
生物等价性 生物等价性测试 p 值的组合测试.非线性混合效应模型对样本大小的重新估计.两个单面试验.两个阶段的设计设计.我类型的错误控制控制.

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