A Modern Approach to Stability Studies via Bayesian Linear Mixed Models Incorporating Auxiliary Effects.

导出 LinkOut

翻译打印收藏纠错

第一作者： Miguel,Cordero

第一单位： Chair of Statistics and Econometrics, University of Bamberg, Feldkirchenstraße 21, D-96052 Bamberg.

作者： Miguel,Cordero ^[1] ; Florian,Meinfelder ^[1] ; Tobias,Eilert ^[2]

作者单位： Chair of Statistics and Econometrics, University of Bamberg, Feldkirchenstraße 21, D-96052 Bamberg. ^[1] Boehringer Ingelheim Pharma GmbH & Co. KG, CMC Statistics BioPharma, Birkendorfer Straße 65, D-88397 Biberach an der Riß, Germany. ^[2]

关键词 Auxiliary effects Batch distribution Bayes factor Bayesian borrowing Bayesian modelling ICH-Q1E Linear mixed model Model selection Shelf life Shelf life distribution Stability study

主题词贝叶斯定理(Bayes Theorem);药物稳定性(Drug Stability);线性模型(Linear Models);药物贮藏(Drug Storage);药用制剂(Pharmaceutical Preparations)

DOI 10.1016/j.xphs.2024.02.020

PMID 38417792

发布时间 2024-06-14

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交