Pon Annpey, Raghavarao Damaraju
Biostatistics, Novartis Pharmaceuticals Corp., East Hanover, NJ 07936-1080, USA.
J Biopharm Stat. 2002 Aug;12(3):277-93. doi: 10.1081/bip-120014559.
To reduce the cost of stability testing in drug research and development, both bracketing and matrixing designs are recommended in the U.S. Food and Drug Administration's (FDA) guidelines for drug products with a single active ingredient (component). When the drug product contains multiple active components, the naïve approach is to take the minimum of shelf lives obtained from individual components as the labeled shelf life. The purpose of this article is to compare the distributions of the shelf life obtained as the minimum shelf life of two components for full FDA's sampling plan, matrixing, and bracketing designs. The results were obtained based on theoretical considerations and simulation studies.
为降低药物研发中稳定性测试的成本，美国食品药品监督管理局（FDA）针对单一活性成分（组分）的药品指南推荐了分组设计和矩阵设计。当药品含有多种活性成分时，简单的方法是以各成分获得的最短保质期中的最小值作为标注的保质期。本文旨在比较对于完整的FDA抽样计划、矩阵设计和分组设计，将两种成分的最短保质期作为保质期所得到的分布情况。结果是基于理论考量和模拟研究得出的。
