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 186

Table 8.4 Regression analysis of eight OPIs from the blinded IPAC-RS APSD database
Product Metric b 0 b 1 Model R 2 (%)

w9k201 Ratio 0.00284634 3.69211 Power 99.9

Group 1 −40.84 22.076 Linear 48.2

Group 2 −32.049 12.2654 Linear 79.4

Group 3 41.951 −2.929 Linear 5.2

Group 4 16.653 −2.8122 Linear 25.5

w9k901 Ratio 0.118678 3.0304 Power 99.7

Group 1 58.888 3.252 Linear 0.5

Group 2 −17.71 8.5686 Linear 74.5

Group 3 −7.11 11.301 Linear 13.6

Group 4 6.8964 −1.3431 Linear 13.4

w9j901 Ratio 0.00618604 4.24202 Power 99.8

Group 1 42.328 0.995 Linear 0.2

Group 2 −30.489 18.0471 Linear 91.8

Group 3 68.16 −10.151 Linear 37.7

Group 4 17.988 −5.67 Linear 28.9

w9j601 Ratio 0.0684496 3.53278 Power 99.8

Group 1 65.34 2.018 Linear 0.1

Group 2 −2.9706 2.2962 Linear 50.1

Group 3 41.459 0.088 Linear 0.0

Group 4 7.97 −1.7094 Linear 31.5

w9j801 Ratio 0.10997 2.85358 Power 99.6

Group 1 30.549 20.56 Linear 31.9

Group 2 −3.5972 6.4721 Linear 59.3

Group 3 56.861 −10.406 Linear 15.1

Group 4 25.0026 −11.1332 Linear 73.5

w9k001 Ratio 0.00731676 4.1528 Power 99.9

Group 1 −20.109 11.304 Linear 12.0

Group 2 −36.46 14.9147 Linear 59.4

Group 3 58.554 −2.684 Linear 0.9

Group 4 41.804 −9.5447 Linear 57.1

w9jk01 Ratio 0.0150038 3.24843 Power 99.3

Group 1 90.81 −9.985 Linear 2.8

Group 2 −18.585 8.5812 Linear 59.2

Group 3 −9.537 13.078 Linear 8.5

Group 4 6.522 0.3908 Linear 0.2

w9kw01 Ratio 0.0292224 2.99468 Power 99.9

Group 1 −4.411 7.623 Linear 10.6

Group 2 −15.472 9.6498 Linear 62.3

Group 3 25.338 5.684 Linear 5.4

Group 4 73.147 −17.9754 Linear 77.9

This represents an interval expected to contain 95% of the time or with 95%
confidence, an individual MMAD value associated with a particular ratio value.
The projected prediction intervals from the different regression models are
reported in Table 8.5 . The prediction intervals for the ratio are narrower than for the
grouped stages, highlighting the fact that the ratio is able to detect changes in
MMAD with more precision compared to grouped stages.