Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 199

Fig. 8.21 Superimposed CI-measured APSDs for CFC suspension MDI ( w9j601 ) from the
IPAC-RS database
Fig. 8.22 Stage-by-stage box plots of CI results for CFC suspension MDI w9j601 ; the encircled
“plus” signs represent the stage mean values for all n = 43 results
logistic sigmoidal model to the cumulative APSD. Figures 8.22 and 8.23 illustrate
the outcomes for product w9j601 .
Limits were established by first constructing a goodness-of-fit statistic based on the
concept of a coefficient of determination ( R 2 ). The target APSD was displaced by its