| Autor: |
C. Thomas Lin, Hongyuan Cao, Yan Lan |
| Rok vydání: |
2012 |
| Předmět: |
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| Zdroj: |
Statistics in Biopharmaceutical Research. 4:136-148 |
| ISSN: |
1946-6315 |
| DOI: |
10.1198/sbr.2011.10037 |
| Popis: |
IPAC-RS developed a two-sided PTI test procedure in 2001 in response to the FDA draft guidance tests (FDA/CDER 1998; FDA/CDER 1999) for delivered dose uniformity for aerosol products. Subsequently, FDA proposed a two one-sided PTI test procedure (2005) to replace the original guidance test. The latter procedure was recently characterized and evaluated by Novick et al. (2009). The two procedures control product quality using different algorithms. In this article we evaluate the performance of these two procedures by simulations for different scenarios of parameter settings (mean, standard deviation, and sample size). Operating characteristic curves and contour plots for acceptance (or rejection) regions are generated to describe the consumer risk and the producer risk under each scenario. We apply the two procedures to batches produced under realistic simulated production situations and to mixtures of normally distributed DDU (delivered dose uniformity) data from simulated multidose products to illustrate ... |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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