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Fig. 5 | AAPS Open

Fig. 5

From: An industrial case study: QbD to accelerate time-to-market of a drug product

Fig. 5

Update of the criticality assessment for the process parameters of unit operation UO2 in the iRISKTM platform (left-hand panel) based on the DoE outcomes (right-hand panel; the plot shows the actual versus predicted values by the model fitted for one of the responses evaluated in the DoE (assay of API-1)). Criticality of parameters UO2_PP4 and UO2_PP3 was set as critical (CPP = critical process parameter) since their variation affects the assay of API-1 (at the 0.05 significance level)

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