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Statistical properties of the USP dissolution test with pooled samples.

Authors
Type
Published Article
Journal
PDA journal of pharmaceutical science and technology / PDA
Publication Date
Volume
59
Issue
5
Pages
310–319
Identifiers
PMID: 16316066
Source
Medline
License
Unknown

Abstract

The Montecarlo simulation method is used to study the statistical properties of the USP pooled dissolution test. In this paper, the statistical behavior of the dissolution test for pooled samples is studied, including: a) the operating characteristic curve showing the probability of passing the test versus the mean amount dissolved, b) the influence of measurement uncertainty on the result of the test, c) an analysis of the dependence of the statistical behavior on the underlying distribution of the individual amounts dissolved, d) a comparison of the statistical behavior of the unit dissolution test versus the pooled dissolution test, e) the average number of stages needed to reach a decision presented as a function of parameters of the lot, f) the relative influence of the three stages of the test on the probability of acceptance.

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