A new approach to estimating shelf-life

被引：12
|
作者：
Kiermeier, A
Jarrett, RG
Verbyla, AP
机构：
[1] Univ Adelaide, Biometr SA, SARDI, Glen Osmond, SA 5064, Australia
[2] CSIRO, Math & Informat Sci, Clayton, Vic 3169, Australia
来源：
PHARMACEUTICAL STATISTICS | 2004年 / 3卷 / 01期
关键词：
constraint; modified profile likelihood; quantile; shetf-life; stability analysis;
D O I：
10.1002/pst.78
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The current approach to the estimation of shelf-life and the determination of the label shelf-life as detailed in the International Conference on Harmonisation guidelines to industry is presented. The shortcomings of the status quo are explained and a possible solution is offered, which gives rise to a new definition of shelf-life. Several methods for calculating a label shelf-life are presented and investigated using a simulation study. Recommendations to adopt the new definition and to increase sample sizes are made. Copyright (C) 2004 John Wiley Sons Ltd.
引用
收藏
页码：3 / 11
页数：9
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