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 222

Fig. 8.55 Plot illustrating the ability of LPM / SPM ratio to predict MMAD ; the width of the range
of acceptable MMAD values is approximately eight times larger than the uncertainty interval of the
prediction, indicating a relatively high capability to discriminate different values of MMAD with
the acceptance limits

Table 8.10 IPAC-RS database file codes for OCC assessment process

Figure(s) depicting
OCC assessment File code OIP type

w9k001 CFC suspension MDI 8.49-8.53

w9j601 CFC suspension MDI 8.56

w9j801 HFA solution MDI 8.57

w9j901 HFA suspension MDI 8.58

w9jk01 DPI 8.59

w9k201 HFA suspension MDI 8.60

w9k901 DPI 8.61

w9kw01 CFC suspension MDI 8.62

43 and 39 CI data sets, respectively. The techniques used for expanding the range of
APSD shifts also allowed for potential changes in ISM that could be expected to
occur due to physical mechanisms associated with APSD shifts in OIPs. In some
cases shifts in APSD were accompanied by an increase or decrease in the mass of
API entering the size-fractionating CI stages contributing to ISM , resulting in a
corresponding increase or decrease in this metric.
These assessments show that when ISM is included, the decision-making process
can detect changes in the amount (mass of API) as well as the shape of the APSD.
The OC curve plots show instances of correct rejection, due to unacceptable ISM ,
even when the MMAD was still within an acceptable range. This is evident in the
black plot symbols (indicating a correct decision), within the acceptable range of
MMAD , but outside the acceptable range for grouped stages or ratio. Assessments
presented in Figs. 8.56 , 8.57 , 8.58 , 8.59 , 8.60 , 8.61 , and 8.62 show results consistent