Parametric two-tier sequential quality assurance test of delivery dose uniformity of multiple-dose inhaler and dry powder inhaler drug products

被引：8
|
作者：
Tsong, Yi [1 ]
Shen, Meiyu [1 ]
Lostritto, Richard T. [2 ]
Poochikian, Guiragos K. [2 ]
机构：
[1] US FDA, Ctr Drug Evaluat & Res, Off Translat Sci, Off Biostat, Silver Spring, MD 20993 USA
[2] US FDA, Ctr Drug Evaluat & Res, Off Pharmaceut Sci, Off New Drug Qual Assurance, Silver Spring, MD 20993 USA
来源：
JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2008年 / 18卷 / 05期
关键词：
delivered dose uniformity; double one-sided test; FDA draft guidance method; tolerance interval; two-tier group sequential;
D O I：
10.1080/10543400802287222
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The delivery dose uniformity is one of the most critical requirements of dry powder inhaler and metered dose inhaler products. In 1998, the U.S. Food and Drug Administration recommended a two-tier acceptance sampling plan in the Draft Guidance of Metered Dose Inhaler and Dry Powder Inhaler Drug Products Chemistry, Manufacturing and Controls. The two-tier procedure is a modification of the United States Pharmacopeia (USP) sampling plan of dose content uniformity. It employed a zero tolerance criterion. In addition, it has a near-zero probability acceptance at the second tier. In this article, a two-tier sequential tolerance interval approach is proposed that is equivalent to a two-tier two one-sided testing procedure. It controls the probability of the product delivering below a prespecified effective dose and the probability of the product delivering over a prespecified safety dose.
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页码：976 / 984
页数：9
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