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 209

Table 8.7 Key to comparisons in Table 8.8

R 2 value used to establish limits

(a) Type I region, lower limit (b) Type I region, upper limit

(c) Type II region, lower limit (d) Type II region, upper limit

Table 8.8 Qualitative comparison of OCCs for OIP APSDs from the IPAC-RS database in the
critical regions related to type I and II errors: EDA = decision based on ratio metric ( LPM / SPM );
Gr24: decision based on stage groups 2 and 4 (excluding group 3)
HFA suspension MDI ( w9k201 ) HFA suspension MDI ( w9j901 )

R 2 = 0.9 R 2 = 0.8 R 2 = 0.9 R 2 = 0.8

EDA EDA EDA EDA EDA EDA ≈ EDA

EDA EDA ≈ EDA ≈ EDA ≈ EDA

R 2 = 0.7 R 2 = 0.6 R 2 = 0.7 R 2 = 0.6

≈ EDA ≈ EDA ≈ EDA Gr24 EDA

≈ EDA ≈ EDA ≈ EDA Gr24 EDA

HFA solution MDI ( w9j801 ) Dry powder inhaler ( w9jk01 )

R 2 = 0.9 R 2 = 0.8 R 2 = 0.9 R 2 = 0.8

EDA EDA EDA EDA EDA EDA EDA EDA

EDA EDA EDA EDA EDA EDA EDA EDA

R 2 = 0.7 R 2 = 0.6 R 2 = 0.7 R 2 = 0.6

Gr24 EDA Gr24 EDA ≈ EDA ≈ EDA

Gr24 EDA Gr24 EDA ≈ EDA Gr24 EDA

Dry powder inhaler ( w9k901 ) CFC suspension MDI ( w9j601 )

R 2 = 0.9 R 2 = 0.8 R 2 = 0.9 R 2 = 0.8

EDA EDA EDA EDA EDA EDA Gr24 ≈

EDA EDA EDA EDA ≈ EDA Gr24 EDA

R 2 = 0.7 R 2 = 0.6 R 2 = 0.7 R 2 = 0.6

EDA EDA EDA EDA Gr24 EDA Gr24 EDA

≈ EDA ≈ EDA Gr24 EDA Gr24 EDA

CFC suspension MDI ( w9k001 ) CFC suspension MDI ( w9kw01 )

R 2 = 0.9 R 2 = 0.8 R 2 = 0.9 R 2 = 0.8

≈ EDA ≈ EDA ≈ EDA Gr24 EDA

≈ EDA Gr24 EDA Gr24 EDA Gr24 EDA

R 2 = 0.7 R 2 = 0.6 R 2 = 0.7 R 2 = 0.6

Gr24 EDA Gr24 EDA Gr24 EDA Gr24 EDA

Gr24 EDA Gr24 EDA Gr24 EDA Gr24 EDA

with the overall curve closer to the ideal OCC then to either of the stage grouping-
based alternatives.
Tables 8.7 and 8.8 summarize qualitatively a comparison of these OCCs in the
critical regions related to type I (false acceptance) and type II (false rejection) errors
(Fig. 8.38 ).
The entries in the cells in Tables 8.7 and 8.8 indicate superior performance for
the indicated metrics in the critical region of the OCC. Where no significant differ-
ence is observed, a character “≈” appears. Bolded values indicate that only the indi-
cated metric is capable and that there is a serious performance issue with the
alternative metric.