ESTIMATING DRUG SHELF-LIFE WITH RANDOM BATCHES

被引：42

作者：

CHOW, SC ^{[1
]}

SHAO, J ^{[1
]}

机构：

[1] UNIV OTTAWA,DEPT MATH,OTTAWA K1N 6N5,ONTARIO,CANADA

来源：

BIOMETRICS | 1991年 / 47卷 / 03期

关键词：

CONFIDENCE BOUND; SHELF-LIFE; STABILITY; WEIGHTED LEAST SQUARES;

D O I：

10.2307/2532659

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

The problem of assessing the shelf-lives of drug products in the market is considered. We focus on the situation where the drug characteristic of interest has a linear relationship over time and batch-to-batch variation is present. Two methods for assessing shelf-lives are proposed based on the weighted least squares method under a regression model with random coefficients. An application to some stability data from the pharmaceutical industry is presented.

引用

页码：1071 / 1079

页数：9