使用混合效应模型估算药物的保质期。

Estimation of the shelf-life of drugs with mixed effects models.

作者信息

Chen J J, Hwang J S, Tsong Y

机构信息

Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas 72079, USA.

出版信息

J Biopharm Stat. 1995 Mar;5(1):131-40. doi: 10.1080/10543409508835102.

DOI:10.1080/10543409508835102

PMID:7613558

Abstract

This paper proposes a normal mixed effects model for stability analysis. An EM algorithm is developed to compute the maximum likelihood estimates of regression coefficients of the fixed effects and random effects, and variance components. The likelihood ratio test is used for the preliminary testing of batch-to-batch variation. An example from a marketing stability study is given to illustrate the proposed procedure.

摘要

本文提出了一种用于稳定性分析的正态混合效应模型。开发了一种期望最大化（EM）算法来计算固定效应、随机效应的回归系数以及方差分量的最大似然估计值。似然比检验用于批次间差异的初步检验。给出了一个来自市场稳定性研究的例子来说明所提出的程序。