RT Journal Article
SR Electronic
T1 Statistical Properties of the USP Dissolution Test with Pooled Samples
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 310
OP 319
VO 59
IS 5
A1 Carlos D. Saccone
A1 Nora S. Meneces
A1 Julio Tessore
YR 2005
UL http://journal.pda.org/content/59/5/310.abstract
AB 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.