Bayesian model averaging of longitudinal dose-response models

被引:0
|
作者
Payne, Richard D. [1 ,3 ]
Ray, Pallavi [1 ]
Thomann, Mitchell A. [2 ]
机构
[1] Eli Lilly & Co, Global Stat Sci, Indianapolis, IN USA
[2] Boehringer Ingelheim Pharmaceut Inc, Dept Biostat & Data Sci, Ridgefield, CT USA
[3] Lilly Corp Ctr, Global Stat Sci, Indianapolis, IN 46285 USA
关键词
dose response; Bayesian model averaging; longitudinal modeling; dose selection; clinical trials; CLINICAL-TRIALS;
D O I
10.1080/10543406.2023.2292214
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Selecting a safe and clinically beneficial dose can be difficult in drug development. Dose justification often relies on dose-response modeling where parametric assumptions are made in advance which may not adequately fit the data. This is especially problematic in longitudinal dose-response models, where additional parametric assumptions must be made. This paper proposes a class of longitudinal dose-response models to be used in the Bayesian model averaging paradigm which improve trial operating characteristics while maintaining flexibility a priori. A new longitudinal model for non-monotonic longitudinal profiles is proposed. The benefits and trade-offs of the proposed approach are demonstrated through a case study and simulation.
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页码:349 / 365
页数:17
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