Estimation of the probability of passing the USP dissolution test

Hsiuying Wang*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

To ensure that a drug product will meet standards for identity, strength and stability as specified in the United States Pharmacopedia and National Formulary (USP/NF), it needs to pass a number of tests such as the content uniformity test and dissolution test at various stages of the manufacturing process. The sponsors usually have in-house specification limits based on some lower bounds of the probabilities of passing USP/NF tests to make sure that there is a high probability of passing the tests. Several probability lower bounds for dissolution test have been provided in the literature. In this paper, a method of calculating the probabilities of passing the dissolution tests is proposed. For the population mean and variance in some specified range, the probability derived from the methodology is very close to the exact probability. Therefore, the proposed method can provide an easy and accurate way to calculate the probability.

Original languageEnglish
Pages (from-to)407-413
Number of pages7
JournalJournal of Biopharmaceutical Statistics
Volume17
Issue number3
DOIs
StatePublished - 1 May 2007

Keywords

  • Dissolution test

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