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.
- Pooled dissolution test
- Unit sample dissolution test
- Operating curve
- Statistical properties
- USP
- Simulation
Footnotes
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.
Log in using your username and password
Log in through your institution
Purchase access
patientACCESS
In This Issue
Jump to section
Related Articles
Cited By...
- No citing articles found.